Trial Outcomes & Findings for Daily Self-weighing and Holiday-associated Weight Gain in Adults (NCT NCT03718000)
NCT ID: NCT03718000
Last Updated: 2022-06-01
Results Overview
Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
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.
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
Control
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
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 Study
STARTED
|
55
|
56
|
|
Overall Study
COMPLETED
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Control
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
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 Study
Relocation
|
2
|
4
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during t he holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 10.6 • n=55 Participants
|
30.5 years
STANDARD_DEVIATION 12.1 • n=56 Participants
|
29.4 years
STANDARD_DEVIATION 11.4 • n=111 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=55 Participants
|
41 Participants
n=56 Participants
|
82 Participants
n=111 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=55 Participants
|
15 Participants
n=56 Participants
|
29 Participants
n=111 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
55 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
111 Participants
n=111 Participants
|
|
Height
|
166.9 cm
STANDARD_DEVIATION 9.5 • n=55 Participants
|
167.5 cm
STANDARD_DEVIATION 8.4 • n=56 Participants
|
167.2 cm
STANDARD_DEVIATION 9.0 • n=111 Participants
|
|
Weight
|
67.0 kg
STANDARD_DEVIATION 13.1 • n=55 Participants
|
66.6 kg
STANDARD_DEVIATION 11.9 • n=56 Participants
|
66.8 kg
STANDARD_DEVIATION 12.5 • n=111 Participants
|
|
Total Body Fat Percentage
|
25.9 percentage of body fat
STANDARD_DEVIATION 8.3 • n=55 Participants
|
26.4 percentage of body fat
STANDARD_DEVIATION 6.7 • n=56 Participants
|
26.2 percentage of body fat
STANDARD_DEVIATION 7.5 • n=111 Participants
|
|
Waist Circumference
|
81.6 cm
STANDARD_DEVIATION 11.2 • n=55 Participants
|
79.3 cm
STANDARD_DEVIATION 9.4 • n=56 Participants
|
80.5 cm
STANDARD_DEVIATION 10.3 • n=111 Participants
|
|
Hip Circumference
|
102.0 cm
STANDARD_DEVIATION 8.6 • n=55 Participants
|
101.4 cm
STANDARD_DEVIATION 7.7 • n=56 Participants
|
101.7 cm
STANDARD_DEVIATION 8.2 • n=111 Participants
|
|
Systolic Blood Pressure
|
115.2 mmHg
STANDARD_DEVIATION 13.5 • n=55 Participants
|
114.2 mmHg
STANDARD_DEVIATION 11.4 • n=56 Participants
|
114.7 mmHg
STANDARD_DEVIATION 12.5 • n=111 Participants
|
|
Diastolic Blood Pressure
|
75.6 mmHg
STANDARD_DEVIATION 9.2 • n=55 Participants
|
73.3 mmHg
STANDARD_DEVIATION 8.3 • n=56 Participants
|
74.5 mmHg
STANDARD_DEVIATION 8.8 • n=111 Participants
|
|
Total Cholesterol
|
172.4 mg/dL
STANDARD_DEVIATION 46.9 • n=55 Participants
|
165.3 mg/dL
STANDARD_DEVIATION 32.0 • n=56 Participants
|
168.9 mg/dL
STANDARD_DEVIATION 39.5 • n=111 Participants
|
|
Triglyceride
|
79.8 mg/dL
STANDARD_DEVIATION 32.0 • n=55 Participants
|
95.0 mg/dL
STANDARD_DEVIATION 51.5 • n=56 Participants
|
87.4 mg/dL
STANDARD_DEVIATION 41.8 • n=111 Participants
|
|
HDL-Cholesterol
|
53.8 mg/dL
STANDARD_DEVIATION 11.7 • n=55 Participants
|
50.9 mg/dL
STANDARD_DEVIATION 12.6 • n=56 Participants
|
52.4 mg/dL
STANDARD_DEVIATION 12.2 • n=111 Participants
|
|
LDL-Cholesterol
|
102.7 mg/dL
STANDARD_DEVIATION 47.2 • n=55 Participants
|
96.4 mg/dL
STANDARD_DEVIATION 24.6 • n=56 Participants
|
99.6 mg/dL
STANDARD_DEVIATION 35.9 • n=111 Participants
|
|
Body Mass Index (BMI)
|
23.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=55 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 2.9 • n=56 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 3.2 • n=111 Participants
|
PRIMARY outcome
Timeframe: 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.Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g.
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday
Pre- to Post-Holiday
|
2.65 kg
Standard Deviation 0.33
|
-0.13 kg
Standard Deviation 0.27
|
|
Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday
Pre- to 14-week follow-up post-holiday
|
1.51 kg
Standard Deviation 0.39
|
-0.15 kg
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 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.weight and height will be combined to report BMI in kg/m\^2
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Body Mass Index (BMI) (kg/m^2)
Visit 2
|
24.9 kg/m^2
Standard Deviation 3.6
|
23.7 kg/m^2
Standard Deviation 2.9
|
|
Body Mass Index (BMI) (kg/m^2)
Visit 3
|
24.5 kg/m^2
Standard Deviation 4.0
|
23.7 kg/m^2
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 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.Dual Energy X-Ray Absorptiometry
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Body Fat (%)
Visit 2
|
26.7 Percentage of body fat
Standard Deviation 8.5
|
25.3 Percentage of body fat
Standard Deviation 6.6
|
|
Body Fat (%)
Visit 3
|
26.7 Percentage of body fat
Standard Deviation 8.3
|
26.1 Percentage of body fat
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 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.Measuring tape
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Waist Circumference (cm)
Visit 2
|
81.4 cm
Standard Deviation 10.8
|
80.6 cm
Standard Deviation 9.3
|
|
Waist Circumference (cm)
Visit 3
|
79.5 cm
Standard Deviation 10.5
|
79.1 cm
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 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.Measuring tape
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Hip Circumference (cm)
Visit 2
|
102.2 cm
Standard Deviation 10.0
|
102.2 cm
Standard Deviation 12.0
|
|
Hip Circumference (cm)
Visit 3
|
100.9 cm
Standard Deviation 9.9
|
100.1 cm
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 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.Fasting blood draw
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Concentration of Blood Triglyceride (mg/dL)
Visit 2
|
81.6 mg/dL
Standard Deviation 34.0
|
90.5 mg/dL
Standard Deviation 54.3
|
|
Concentration of Blood Triglyceride (mg/dL)
Visit 3
|
80.3 mg/dL
Standard Deviation 34.4
|
85.7 mg/dL
Standard Deviation 39.7
|
SECONDARY outcome
Timeframe: 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.Fasting blood draw
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
Visit 2
|
52.1 mg/dL
Standard Deviation 11.9
|
51.5 mg/dL
Standard Deviation 15.3
|
|
Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
Visit 3
|
53.0 mg/dL
Standard Deviation 11.6
|
51.7 mg/dL
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 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.Fasting blood draw
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
Visit 2
|
101.2 mg/dL
Standard Deviation 49.6
|
91.3 mg/dL
Standard Deviation 26.8
|
|
Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
Visit 3
|
99.5 mg/dL
Standard Deviation 50.0
|
90.0 mg/dL
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: 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.Fasting blood draw
Outcome measures
| Measure |
Control
n=55 Participants
Participants in this group received no intervention during the holiday season
|
Daily Self-Weighing (DSW)
n=56 Participants
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.
|
|---|---|---|
|
Concentration of Blood Total Cholesterol (TC) (mg/dL)
Visit 2
|
169.6 mg/dL
Standard Deviation 52.9
|
159.6 mg/dL
Standard Deviation 34.6
|
|
Concentration of Blood Total Cholesterol (TC) (mg/dL)
Visit 3
|
168.6 mg/dL
Standard Deviation 51.8
|
158.8 mg/dL
Standard Deviation 39.7
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Self-Weighing (DSW)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jamie Cooper, Associate Professor
University of Georgia
Phone: 706-542-4903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place