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Daily Self-weighing and Holiday-associated Weight Gain in Adults

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ClinicalTrials.gov Identifier: NCT03718000
Recruitment Status : Completed
First Posted : October 24, 2018
Results First Posted : June 13, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jamie Cooper, PhD, University of Georgia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Obesity
Intervention Device: Daily self-weighing (DSW)
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description Participants in this group received no intervention during the holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Period Title: Overall Study
Started 55 56
Completed 53 51
Not Completed 2 5
Reason Not Completed
Relocation             2             4
Pregnancy             0             1
Arm/Group Title Control Daily Self-Weighing (DSW) Total
Hide Arm/Group Description Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Total of all reporting groups
Overall Number of Baseline Participants 55 56 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 56 participants 111 participants
28.3  (10.6) 30.5  (12.1) 29.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 111 participants
Female
41
  74.5%
41
  73.2%
82
  73.9%
Male
14
  25.5%
15
  26.8%
29
  26.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 55 participants 56 participants 111 participants
55
 100.0%
56
 100.0%
111
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 55 participants 56 participants 111 participants
166.9  (9.5) 167.5  (8.4) 167.2  (9.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 55 participants 56 participants 111 participants
67.0  (13.1) 66.6  (11.9) 66.8  (12.5)
Total Body Fat Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage of body fat
Number Analyzed 55 participants 56 participants 111 participants
25.9  (8.3) 26.4  (6.7) 26.2  (7.5)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 55 participants 56 participants 111 participants
81.6  (11.2) 79.3  (9.4) 80.5  (10.3)
Hip Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 55 participants 56 participants 111 participants
102.0  (8.6) 101.4  (7.7) 101.7  (8.2)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 55 participants 56 participants 111 participants
115.2  (13.5) 114.2  (11.4) 114.7  (12.5)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 55 participants 56 participants 111 participants
75.6  (9.2) 73.3  (8.3) 74.5  (8.8)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 55 participants 56 participants 111 participants
172.4  (46.9) 165.3  (32.0) 168.9  (39.5)
Triglyceride  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 55 participants 56 participants 111 participants
79.8  (32.0) 95.0  (51.5) 87.4  (41.8)
HDL-Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 55 participants 56 participants 111 participants
53.8  (11.7) 50.9  (12.6) 52.4  (12.2)
LDL-Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 55 participants 56 participants 111 participants
102.7  (47.2) 96.4  (24.6) 99.6  (35.9)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 55 participants 56 participants 111 participants
23.9  (3.5) 23.6  (2.9) 23.8  (3.2)
[1]
Measure Description: weight and height were combined to report BMI in kg/m^2
1.Primary Outcome
Title Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday
Hide Description Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g.
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during the holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: kg
Pre- to Post-Holiday 2.65  (0.33) -0.13  (0.27)
Pre- to 14-week follow-up post-holiday 1.51  (0.39) -0.15  (0.35)
2.Secondary Outcome
Title Body Mass Index (BMI) (kg/m^2)
Hide Description weight and height will be combined to report BMI in kg/m^2
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Visit 2 24.9  (3.6) 23.7  (2.9)
Visit 3 24.5  (4.0) 23.7  (2.9)
3.Secondary Outcome
Title Body Fat (%)
Hide Description Dual Energy X-Ray Absorptiometry
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: Percentage of body fat
Visit 2 26.7  (8.5) 25.3  (6.6)
Visit 3 26.7  (8.3) 26.1  (6.6)
4.Secondary Outcome
Title Waist Circumference (cm)
Hide Description Measuring tape
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: cm
Visit 2 81.4  (10.8) 80.6  (9.3)
Visit 3 79.5  (10.5) 79.1  (9.4)
5.Secondary Outcome
Title Hip Circumference (cm)
Hide Description Measuring tape
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: cm
Visit 2 102.2  (10.0) 102.2  (12.0)
Visit 3 100.9  (9.9) 100.1  (8.1)
6.Secondary Outcome
Title Concentration of Blood Triglyceride (mg/dL)
Hide Description Fasting blood draw
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
Visit 2 81.6  (34.0) 90.5  (54.3)
Visit 3 80.3  (34.4) 85.7  (39.7)
7.Secondary Outcome
Title Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
Hide Description Fasting blood draw
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
Visit 2 52.1  (11.9) 51.5  (15.3)
Visit 3 53.0  (11.6) 51.7  (13.2)
8.Secondary Outcome
Title Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
Hide Description Fasting blood draw
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
Visit 2 101.2  (49.6) 91.3  (26.8)
Visit 3 99.5  (50.0) 90.0  (25.5)
9.Secondary Outcome
Title Concentration of Blood Total Cholesterol (TC) (mg/dL)
Hide Description Fasting blood draw
Time Frame Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year’s Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description:
Participants in this group received no intervention during t he holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Overall Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
Visit 2 169.6  (52.9) 159.6  (34.6)
Visit 3 168.6  (51.8) 158.8  (39.7)
Time Frame [Not Specified]
Adverse Event Reporting Description All-Cause Mortality, Serious, and other adverse events were not monitored/assessed.
 
Arm/Group Title Control Daily Self-Weighing (DSW)
Hide Arm/Group Description Participants in this group received no intervention during the holiday season

Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season

Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

All-Cause Mortality
Control Daily Self-Weighing (DSW)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Control Daily Self-Weighing (DSW)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Daily Self-Weighing (DSW)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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: Dr. Jamie Cooper, Associate Professor
Organization: University of Georgia
Phone: 706-542-4903
EMail: jamie.cooper@uga.edu
Layout table for additonal information
Responsible Party: Jamie Cooper, PhD, University of Georgia
ClinicalTrials.gov Identifier: NCT03718000     History of Changes
Other Study ID Numbers: STUDY00004735
First Submitted: October 17, 2018
First Posted: October 24, 2018
Results First Submitted: April 23, 2019
Results First Posted: June 13, 2019
Last Update Posted: June 25, 2019