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Financial Incentives to Exercise for Adolescents (MOVE)

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: NCT01848353
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : March 14, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Insulin Resistance
Obesity
Sedentary Lifestyle
Intervention Behavioral: Exercise training
Enrollment 142
Recruitment Details Recruitment for the exercise intervention was July 2013 - April 2016. Recruitment for the reference group was July 2015 - April 2017. All participants were were recruited from medical clinics, schools, or community settings in Southeast Oklahoma.
Pre-assignment Details 142 people enrolled (completed informed consent). During screening, 4 OW/Ob and 8 NW people were disqualified, and 5 OW/Ob and 5 NW people voluntarily withdrew. Baseline data were thus available for 120 people. After baseline testing was complete, 81 OW/Ob participants were randomly assigned to either standard pay or incentive group for Phase 1.
Arm/Group Title Standard Payment Incentivized Payment Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1), or increase exercise duration (minutes per session) during weeks 17-32 (phase 2). In phase 3 the payment will be a lottery, with the number of lottery chances based on exercise frequency and duration. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest. This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Period Title: Phase 1
Started 38 43 20 19
Completed 35 42 20 19
Not Completed 3 1 0 0
Reason Not Completed
Withdrawal by Subject             3             1             0             0
Period Title: Phase 2
Started 23 [1] 28 [1] 0 [2] 0 [2]
Completed 20 26 0 0
Not Completed 3 2 0 0
Reason Not Completed
Withdrawal by Subject             3             2             0             0
[1]
26 participants from Phase 1 intervention (both groups) withdrew and did not complete Phase 2
[2]
Normal weight participants only completed baseline testing in Phase 1.
Period Title: Phase 3
Started 5 [1] 10 [1] 0 [2] 0 [2]
Completed 4 9 0 0
Not Completed 1 1 0 0
Reason Not Completed
Withdrawal by Subject             1             1             0             0
[1]
31 participants from Phase 2 intervention (both groups) withdrew and did not complete Phase 3
[2]
Normal weight participants only completed baseline testing in Phase 1.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Normal Weight, Low Activity Group Normal Weight, High Activity Group Total
Hide Arm/Group Description

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest. This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest. Total of all reporting groups
Overall Number of Baseline Participants 38 43 20 19 120
Hide Baseline Analysis Population Description
Normal weight groups completed only the baseline testing. The overweight/obese group entered the exercise program at phase 1, and then continued on to phases 2 and 3 if they remained enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 43 participants 20 participants 19 participants 120 participants
13.8  (2.2) 14.2  (2.2) 14.6  (2.3) 14.3  (1.9) 14.4  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 43 participants 20 participants 19 participants 120 participants
Female
21
  55.3%
25
  58.1%
11
  55.0%
7
  36.8%
64
  53.3%
Male
17
  44.7%
18
  41.9%
9
  45.0%
12
  63.2%
56
  46.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 43 participants 20 participants 19 participants 120 participants
American Indian or Alaska Native
38
 100.0%
43
 100.0%
20
 100.0%
19
 100.0%
120
 100.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 43 participants 20 participants 19 participants 120 participants
38 43 20 19 186
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 38 participants 43 participants 20 participants 19 participants 120 participants
33.4  (7.0) 34.8  (6.1) 20.8  (1.9) 20.1  (2.4) 30.1  (9.0)
1.Primary Outcome
Title Change From Baseline in Volume of Exercise (Total Time)
Hide Description Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
In Phase 1, 81 people were randomized, but 4 withdrew after assignment so 77 people had exercise behavior data for analyses. In Phase 2, 51 were randomized, but 5 withdrew after assignment, leaving 46 for behavior analyses. In Phase 3, 15 were randomized, 2 withdrew after assignment, leaving 13 for behavior analyses.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3
Hide Arm/Group Description:

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Overall Number of Participants Analyzed 35 42 20 26 4 9
Mean (Standard Deviation)
Unit of Measure: hours
15.2  (10.1) 15.0  (8.1) 8.0  (5.5) 12.4  (11.1) 10.2  (3.8) 8.8  (4.7)
2.Secondary Outcome
Title Insulin Resistance
Hide Description Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (iHOMA2, %S). Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description:

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Overall Number of Participants Analyzed 25 32 9 11 4 6 20 19
Mean (Standard Deviation)
Unit of Measure: % of sensitivity
75  (49) 69  (44) 66  (36) 77  (45) 57  (28) 65  (35) 170  (75) 179  (92)
3.Secondary Outcome
Title Exercise Fitness
Hide Description Peak oxygen uptake (VO2max) during a progressive intensity bicycle test to fatigue. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 2 people in Phase 1 (1 in each group), 1 person in NW low activity group.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description:

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Overall Number of Participants Analyzed 24 31 9 11 4 6 19 19
Mean (Standard Deviation)
Unit of Measure: ml/kg fat free mass/minute
36.9  (8.0) 37.4  (8.6) 39.0  (10.8) 39.2  (12.9) 39.2  (5.8) 43.0  (6.6) 61.7  (7.5) 45.1  (5.4)
4.Secondary Outcome
Title Body Composition
Hide Description Body fat content. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 1 person in NW Lo fit group.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description:

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Overall Number of Participants Analyzed 25 32 9 11 4 6 19 19
Mean (Standard Deviation)
Unit of Measure: Total body fat percentage
43.9  (7.8) 44.4  (7.7) 40.8  (4.4) 40.9  (7.1) 40.4  (3.5) 44.9  (9.1) 21.2  (6.3) 23.3  (7.7)
5.Other Pre-specified Outcome
Title Physical Activity
Hide Description Daily step counts measured with accelerometers. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
In Phase 1, 20 of 77 starters lost to follow-up (no post-test data). In Phase 2, 26 of 46 starters lost to follow-up. In Phase 3, 3 of 13 starters lost to follow-up. Missing data: Phase 1 (4 std, 5 incentive), Phase 2 (2 std, 3 incentive), Phase 3 (1 std, 2 incentive), NW (1 Low, 1 High).
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description:

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Overall Number of Participants Analyzed 21 27 7 8 3 4 19 18
Mean (Standard Deviation)
Unit of Measure: steps per day
6048  (2711) 6028  (3136) 4862  (1217) 6787  (4273) 4166  (1882) 6863  (2321) 9492  (3176) 8338  (3103)
6.Other Pre-specified Outcome
Title Blood Lipids
Hide Description Standard assessment of fasting triglycerides. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Time Frame at baseline (week 0) and weeks 16, 32, and 48.
Hide Outcome Measure Data
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In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
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All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
Overall Number of Participants Analyzed 25 32 9 11 4 6 20 19
Mean (Standard Deviation)
Unit of Measure: mg/dl
92  (56) 97  (68) 64  (30) 114  (87) 83  (50) 102  (80) 51  (24) 60  (30)
Time Frame Adverse events were monitored for each participant for as long as they were actively enrolled in the study, a period of up to 48 weeks for the exercise intervention group.
Adverse Event Reporting Description Injury or illness due to exercise performed as part of the study
 
Arm/Group Title Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Hide Arm/Group Description

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.

Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest. This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
All-Cause Mortality
Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/43 (0.00%)   0/23 (0.00%)   0/28 (0.00%)   0/5 (0.00%)   0/10 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
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Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/43 (0.00%)   0/23 (0.00%)   0/28 (0.00%)   0/5 (0.00%)   0/10 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Payment, Phase 1 Incentivized Payment, Phase 1 Standard Payment, Phase 2 Incentivized Payment, Phase 2 Ramp-down Payment, Phase 3 Raffle Payment, Phase 3 Normal Weight, Low Activity Group Normal Weight, High Activity Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/43 (0.00%)   0/23 (0.00%)   0/28 (0.00%)   0/5 (0.00%)   0/10 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
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
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Name/Title: Kevin Short, PhD, Associate Professor
Organization: University of Oklahoma Health Sciences Center
Phone: (405) 271-8001 ext 43094
EMail: kevin-short@ouhsc.edu
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01848353    
Other Study ID Numbers: P20 MD000528-RP2
First Submitted: April 25, 2013
First Posted: May 7, 2013
Results First Submitted: April 10, 2018
Results First Posted: March 14, 2019
Last Update Posted: April 3, 2019