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Study of Novel Approaches for Prevention (SNAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01183689
Recruitment Status : Active, not recruiting
First Posted : August 18, 2010
Results First Posted : May 7, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Weight Gain
Interventions Behavioral: Small Behavior Changes
Behavioral: Large Behavior Changes
Enrollment 599
Recruitment Details SNAP targeted an enrollment of 600 participants, aged 18-35 years, with a BMI of 21.0 to 30.9. Participants were recruited from 2 clinical sites (Providence, RI and Chapel Hill, NC). The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period (Aug 2010-Feb 2012).
Pre-assignment Details Participants were pre-screened online and by telephone before attending an orientation, followed by two screening visits. 609 participants were randomized; although 10 participants never attended the randomization visit and did not learn of their group assignment.
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description "Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Period Title: Overall Study
Started 202 200 197
Month 4 Visit 197 192 187
Year 1 Visit 187 172 183
Year 2 Visit 178 172 174
Year 3 Visit 139 125 126
Year 4 Visit 38 33 30
Completed 202 200 197
Not Completed 0 0 0
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes Total
Hide Arm/Group Description "Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Total of all reporting groups
Overall Number of Baseline Participants 202 200 197 599
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 202 participants 200 participants 197 participants 599 participants
Age : 18-24 years
53
  26.2%
60
  30.0%
56
  28.4%
169
  28.2%
Age : 25-35 years
149
  73.8%
140
  70.0%
141
  71.6%
430
  71.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 197 participants 599 participants
Female
158
  78.2%
157
  78.5%
154
  78.2%
469
  78.3%
Male
44
  21.8%
43
  21.5%
43
  21.8%
130
  21.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 202 participants 200 participants 197 participants 599 participants
African American
19
   9.4%
25
  12.5%
22
  11.2%
66
  11.0%
Non-Hispanic white
148
  73.3%
146
  73.0%
144
  73.1%
438
  73.1%
Asian/Pacific Islander
7
   3.5%
11
   5.5%
7
   3.6%
25
   4.2%
Hispanic
15
   7.4%
10
   5.0%
21
  10.7%
46
   7.7%
Multiple/Refused
13
   6.4%
8
   4.0%
3
   1.5%
24
   4.0%
BMI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 197 participants 599 participants
<25.0 kg/m2
97
  48.0%
84
  42.0%
96
  48.7%
277
  46.2%
>=25.0 kg/m2
105
  52.0%
116
  58.0%
101
  51.3%
322
  53.8%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 202 participants 200 participants 197 participants 599 participants
71.4  (10.2) 71.9  (11.0) 70.8  (11.0) 71.4  (10.7)
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 197 participants 599 participants
Not college graduate
39
  19.3%
46
  23.0%
35
  17.8%
120
  20.0%
College graduate
163
  80.7%
154
  77.0%
162
  82.2%
479
  80.0%
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 197 participants 599 participants
Employed full time
127
  62.9%
125
  62.5%
125
  63.5%
377
  62.9%
Student full time
49
  24.3%
61
  30.5%
55
  27.9%
165
  27.5%
Other
26
  12.9%
14
   7.0%
17
   8.6%
57
   9.5%
1.Primary Outcome
Title Weight Changes From Baseline Over Follow-up.
Hide Description Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Overall Number of Participants Analyzed 202 200 197
Mean (Standard Error)
Unit of Measure: kilograms
0.26  (0.22) -0.56  (0.22) -2.37  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Small Behavior Changes
Comments Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.23 to 1.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments Above is provided the mean difference between Arms 1 and 2.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Large Behavior Changes
Comments Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments This was fitted with Proc Mixed in SAS.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.64
Confidence Interval (2-Sided) 95%
2.05 to 3.22
Estimation Comments 95% confidence interval excludes 0
2.Secondary Outcome
Title Weight Gain 1 Pound or More at Any Time Over Follow-up
Hide Description Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Overall Number of Participants Analyzed 202 200 197
Mean (Standard Error)
Unit of Measure: percentage gaining 1 pound or more among
40.8  (4.4) 32.5  (3.8) 23.6  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Small Behavior Changes
Comments Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.
Type of Statistical Test Other
Comments Generalized Estimating Equations
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.02 to 1.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Large Behavior Changes
Comments This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.28
Confidence Interval (2-Sided) 95%
1.64 to 3.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Weight Changes
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Overall Number of Participants Analyzed 202 200 197
Mean (Standard Error)
Unit of Measure: kilograms
0.54  (0.33) -0.77  (0.33) -1.50  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Small Behavior Changes
Comments Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.39 to 2.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47
Estimation Comments Listed above is the mean difference between arms 1 and 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Large Behavior Changes
Comments A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments A linear contrast was used to compare groups 1 and 3 at 24 months.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.11 to 2.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Changes in Systolic Blood Pressure
Hide Description Compare changes in systolic blood pressure across the three intervention groups
Time Frame Measured at 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with measurements at Year 2
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: mmHg
1.73  (0.69) -3.72  (0.70) -2.66  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.06 to 3.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Mean differences in systolic blood pressure between groups 1 and 3 over time.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
-0.98 to 2.84
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Changes From Baseline in Diastolic Blood Pressure
Hide Description Change from baseline to 2 years in diastolic blood pressure
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing data at 2 years
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: mmHg
-0.41  (0.51) -2.14  (0.52) -1.33  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
0.32 to 3.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
-0.49 to 2.33
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Changes From Baseline to 2 Years in Total Cholesterol
Hide Description Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Year 2 measures
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: mg/dl
-0.56  (1.75) 0.74  (1.73) 1.33  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean changes from baseline to 2 years were compared between Groups 1 and 2.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments The p-value results from a 2 degree of freedom F-test.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.30
Confidence Interval (2-Sided) 95%
-6.12 to 3.52
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments This p-value is from a 2 degree of freedom test for differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-4.36 to 0.58
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Obesity
Hide Description Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Overall Number of Participants Analyzed 195 195 193
Mean (Standard Error)
Unit of Measure: percentage of participants
16.9  (2.7) 7.9  (2.0) 8.6  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Small Behavior Changes
Comments The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
1.23 to 4.52
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Self-regulation With Large Behavior Changes
Comments Generalized estimating equations were used. Differences were summarized with odds ratios.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments This p-value is from a 2 degree of freedom test for differences among the 3 groups.
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.13
Confidence Interval (2-Sided) 95%
1.12 to 4.10
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Dietary Restraint: Mean Change From Baseline to 2 Years
Hide Description

The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint).

Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: Units on a scale
0.39  (0.18) 0.59  (0.19) 1.27  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups
Method ANOVA
Comments the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.61 to 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Differences among the 3 groups were based on analyses of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments This p-value is from a 2 degree of freedom test for differences among all 3 groups
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.02 to 1.08
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Disinhibition
Hide Description

The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0–16, with higher scores reflecting greater levels of disinhibition).

REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

Time Frame Changes at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: Units on a scale
0.07  (0.17) -0.78  (0.17) -0.03  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Changes in units of the scale from baseline to 2 years
Type of Statistical Test Superiority
Comments A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.
Method ANOVA
Comments The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.32 to -0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.57 to 0.37
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Flexible Dietary Control
Hide Description

Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control.

REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64.

Time Frame Changes from baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: units on a scale
0.39  (0.18) 0.59  (0.19) 1.27  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes, Large Behavior Changes
Comments 2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study
Type of Statistical Test Superiority
Comments 2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study
Statistical Test of Hypothesis P-Value <0.001
Comments 2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints
Method ANOVA
Comments 2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.31 to 0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments This p-value is from a 2 degree freedom test of differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.37 to 1.39
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Rigid Dietary Control
Hide Description

Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control.

REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

Time Frame Changes from baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: 2 year changes in units on a scale
0.35  (0.21) 0.22  (0.21) 1.75  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments 2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 2 degree of freedom F-test from analysis of variance
Method ANOVA
Comments 2 degree of freedom F-test from analysis of variance to compare mean differences among arms
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.71 to 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
0.82 to 1.98
Estimation Comments [Not Specified]
12.Secondary Outcome
Title General Health Index
Hide Description

The General Health Index, a one-item question from the CDC’s Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes.

Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention

Time Frame Changes from baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: 2 year changes in units on a scale
0.04  (0.06) -0.04  (0.06) -0.11  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments 2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments This p-value is from a 2 degree of freedom test for differences among the 3 arms.
Method ANOVA
Comments 2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.24 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments This p-value is from the 2 degree of freedom test of differences among the 3 arms.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.32 to 0.02
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)
Hide Description Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Mean changes among all participants with measurements at Year 2
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: Mean Change from Baseline in mg/dl
-0.09  (0.83) 1.43  (0.82) 2.12  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
-0.77 to 3.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compared mean differences among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments This p-value is from a 2 degree of freedom F test.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
-0.09 to 4.51
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)
Hide Description Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Mean changes from baseline among all participants with year 2 measures
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: Mean change in LDL-C in mg/dl
-0.01  (1.46) 0.16  (1.44) 1.43  (1.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments This p-value is from a 2 degree of freedom F-test from analysis of variance.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-3.89 to 4.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean changes among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments This p-value is from a 2 degree of freedom test.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
-2.61 to 5.49
Estimation Comments No significant differences between groups 1 and 3.
15.Secondary Outcome
Title Mean Change in Fasting Glucose From Baseline to 2 Years
Hide Description Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with measurements at 2 years
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: Mean change from baseline in mg/dl
1.48  (0.49) 0.40  (0.49) -0.18  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-2.44 to 0.28
Estimation Comments No significant difference between groups 1 and 2.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments This p-value is from an F-test to compare differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.66
Confidence Interval (2-Sided) 95%
-3.00 to -0.32
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Change in Fasting Insulin From Baseline to 2 Years
Hide Description Mean change in fasting insulin (uU/ml) from baseline to 2 years
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: Mean changes at 2 years in uU/ml
-0.27  (0.33) -0.73  (0.33) -1.48  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-1.37 to 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-2.11 to -0.30
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Depression Symptomatology
Hide Description Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants with 2 year data
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 178 172 174
Mean (Standard Error)
Unit of Measure: units on a scale
1.68  (0.50) 0.60  (0.51) 1.73  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
-0.84 to 3.00
Estimation Comments The 95% confidence interval for differences between groups 1 and 2 includes 0.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare differences among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments This p-value is from an analysis of variance comparing all 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-1.45 to 1.35
Estimation Comments The 95% confidence interval for differences between groups 1 and 3 includes 0.
18.Secondary Outcome
Title Insulin Resistance
Hide Description We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).
Time Frame Change from baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 158 154 159
Mean (Standard Error)
Unit of Measure: HOMA-IR
-0.03  (0.08) -0.15  (0.08) -0.33  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments 2 degree of freedom F-test to compare mean 2 year differences among 3 arms
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments 2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.34 to 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments This p-value is from a 2 degree of freedom test for differences among the 3 groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.52 to -0.08
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Total Energy Dietary Intake Per Day (Kcals)
Hide Description

Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy.

REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335.

Time Frame Changes from baseline to 2 years in kilocalories
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 167 159 162
Mean (Standard Error)
Unit of Measure: kilocalories
-134  (40) -186  (41) -185  (41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments 2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments 2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -52
Confidence Interval (2-Sided) 95%
-164 to 60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -50
Confidence Interval (2-Sided) 95%
-162 to 61
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change in Waist Circumference (cm)
Hide Description Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.
Time Frame Change from baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 159 154 159
Mean (Standard Error)
Unit of Measure: centimeters
0.21  (0.46) -1.06  (0.47) -2.21  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments 2 degree of freedom F-test from ANOVA to compare differences among 3 arms
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments 2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms
Method ANOVA
Comments No adjustment to degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-2.55 to 0.02
Estimation Comments Difference between groups 1 and 2: 95% confidence interval includes 0
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Mean change in waist girth from baseline to year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments The p-value is from a 2 degree of freedom F-test for differences among the 3 arms
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.42
Confidence Interval (2-Sided) 95%
-3.69 to -1.14
Estimation Comments The 95% confidence interval for differences between groups 1 and 3 does not include 0.
21.Secondary Outcome
Title Self-weighing
Hide Description Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Small Behavior Changes Large Behavior Changes
Hide Arm/Group Description:
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

Exercise: At the start of the program, participants will be given a pedometer and asked

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes

Overall Number of Participants Analyzed 152 145 153
Measure Type: Count of Participants
Unit of Measure: Participants
30
  19.7%
44
  30.3%
56
  36.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Small Behavior Changes
Comments Logistic regression to compare differences among the 3 groups
Type of Statistical Test Superiority
Comments Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.
Statistical Test of Hypothesis P-Value 0.004
Comments This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
1.04 to 3.02
Estimation Comments The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Large Behavior Changes
Comments Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments 2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms
Method Regression, Logistic
Comments No adjustments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.35
Confidence Interval (2-Sided) 95%
1.40 to 3.94
Estimation Comments The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.
22.Other Pre-specified Outcome
Title 6 Year Weight Changes
Hide Description Changes from baseline to year 6 in body weight
Time Frame 6 years
Outcome Measure Data Not Reported
Time Frame Adverse Event Data were collected on all participants from the time the participant signed the consent throughout the duration of the study (an average follow-up of 3 years). Participants were asked at each visit (scheduled to occur at months 4, 12, 24, 36, and 48 depending on when participants were enrolled relative to the end of follow-up) to report any medical events that occurred. Participants were also allowed to contact the clinic staff to report an adverse events at any intervening time
Adverse Event Reporting Description Participants were asked about hospitalizations and any medical events at each study visit (4 months, 1 year, annually thereafter). Participants could also contact the study staff between visits to report an adverse event.
 
Arm/Group Title Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Hide Arm/Group Description "Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

All-Cause Mortality
Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/202 (1.98%)      11/200 (5.50%)      9/197 (4.57%)    
Gastrointestinal disorders       
Gall bladder * [1]  0/202 (0.00%)  0 3/200 (1.50%)  3 1/197 (0.51%)  2
Stomach virus * [2]  0/202 (0.00%)  0 1/200 (0.50%)  1 0/197 (0.00%)  0
Crohn's disease * [3]  0/202 (0.00%)  0 0/200 (0.00%)  0 1/197 (0.51%)  1
General disorders       
Motor Vehicle Accident *  0/202 (0.00%)  0 1/200 (0.50%)  1 0/197 (0.00%)  0
Elective breast surgery * [4]  1/202 (0.50%)  1 0/200 (0.00%)  0 0/197 (0.00%)  0
Benign mass * [5]  0/202 (0.00%)  0 0/200 (0.00%)  0 1/197 (0.51%)  1
Syncope * [6]  0/202 (0.00%)  0 0/200 (0.00%)  0 1/197 (0.51%)  1
Infections and infestations       
Tonsillectomy * [7]  0/202 (0.00%)  0 0/200 (0.00%)  0 1/197 (0.51%)  1
E-coli bacterial infection * [8]  0/202 (0.00%)  0 0/200 (0.00%)  0 1/197 (0.51%)  1
Musculoskeletal and connective tissue disorders       
Musculoskeletal *  1/202 (0.50%)  1 2/200 (1.00%)  2 0/197 (0.00%)  0
Arthritis * [9]  0/202 (0.00%)  0 1/200 (0.50%)  1 0/197 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Obstetric *  2/202 (0.99%)  2 3/200 (1.50%)  3 0/197 (0.00%)  0
Psychiatric disorders       
Psychiatric * [10]  0/202 (0.00%)  0 0/200 (0.00%)  0 3/197 (1.52%)  6
*
Indicates events were collected by non-systematic assessment
[1]
Stomach pain related to gallstones
[2]
Hospitalization for stomach virus
[3]
Hospitalization for Crohn's disease
[4]
Elective breast surgery
[5]
Outpatient surgery for benign mass on left maxillary sinus
[6]
Syncope led to fall and hospitalization for concussion
[7]
Tonsillectomy
[8]
Hospitalization for E-coli bacterial infection
[9]
Rheumatoid arthritis - increased pain following pregnancy -- condition was present 10 years prior to study entry
[10]
One participant was hospitalized 3 times for depression. One participant was hospitalized twice for paranoid schizophrenia. One other participant was hospitalized once for depression.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Self-regulation With Small Behavior Changes Self-regulation With Large Behavior Changes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   119/202 (58.91%)      118/200 (59.00%)      109/197 (55.33%)    
Cardiac disorders       
Cardiovascular   3/202 (1.49%)  3 7/200 (3.50%)  7 7/197 (3.55%)  7
Endocrine disorders       
Diabetes   2/202 (0.99%)  3 1/200 (0.50%)  1 0/197 (0.00%)  0
Gastrointestinal disorders       
Gall bladder   1/202 (0.50%)  1 1/200 (0.50%)  1 1/197 (0.51%)  1
General disorders       
Motor vehicle accident   26/202 (12.87%)  30 28/200 (14.00%)  31 27/197 (13.71%)  30
Other   56/202 (27.72%)  68 40/200 (20.00%)  48 54/197 (27.41%)  64
Metabolism and nutrition disorders       
Weight loss related   1/202 (0.50%)  1 1/200 (0.50%)  1 1/197 (0.51%)  1
Musculoskeletal and connective tissue disorders       
Muscoskeletal   55/202 (27.23%)  65 50/200 (25.00%)  63 45/197 (22.84%)  51
Pregnancy, puerperium and perinatal conditions       
Obstetric   15/202 (7.43%)  21 13/200 (6.50%)  15 10/197 (5.08%)  13
Psychiatric disorders       
Psychiatric   16/202 (7.92%)  17 18/200 (9.00%)  20 16/197 (8.12%)  18
Respiratory, thoracic and mediastinal disorders       
Ashthma Attack   0/202 (0.00%)  0 1/200 (0.50%)  1 2/197 (1.02%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Espeland
Organization: Wake Forest University School of Medicine
Phone: 336-716-2826
EMail: mespelan@wakehealth.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01183689     History of Changes
Other Study ID Numbers: IRB00010097
5U01HL090875 ( U.S. NIH Grant/Contract )
First Submitted: August 13, 2010
First Posted: August 18, 2010
Results First Submitted: November 1, 2017
Results First Posted: May 7, 2018
Last Update Posted: August 20, 2019