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Background: Previous studies report 0.4-1.5kg of weight gain during the holiday season, which may contribute to annual weight gain.
Purpose: To test whether daily self-weighing (DSW) can prevent holiday weight gain.
Hypothesis: We hypothesized that daily self-weighing would effectively prevent weight and fat gain, and that individuals with overweight and obesity would respond most favorably to DSW.
A single-blinded randomized control trial:
Adults (age 18-75y, BMI ≥ 18.5kg/m2) were randomized to either a control or daily self-weighing (DSW) group. There were 3 testing visits: pre-holiday (v1: within 7d before Thanksgiving), post-holiday (v2: within 7d after New Year's Day), and a follow-up (v3: 14 weeks after v2). The DSW group were given Wi-Fi scales that provide graphical feedback of daily weight. They were instructed to perform DSW during the holidays and to try not to gain weight above baseline weights. Anthropometrics were measured at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in this group received no intervention during t he holiday season | |
| Daily Self-Weighing (DSW) | Experimental | Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily self-weighing (DSW) | Device | DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday | Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) (kg/m^2) | weight and height will be combined to report BMI in kg/m^2 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jamie.cooper@uga.edu Cooper, Ph.D. | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia - Department of Foods and Nutrition | Athens | Georgia | 30602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31119881 | Derived | Kaviani S, vanDellen M, Cooper JA. Daily Self-Weighing to Prevent Holiday-Associated Weight Gain in Adults. Obesity (Silver Spring). 2019 Jun;27(6):908-916. doi: 10.1002/oby.22454. |
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The plan is to share group averages through publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants in this group received no intervention during the holiday season |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants in this group received no intervention during t he holiday season |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday | Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g. | Posted | Mean | Standard Deviation | kg | 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. |
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All-Cause Mortality, Serious, and other adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants in this group received no intervention during the holiday season |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Cooper, Associate Professor | University of Georgia | 706-542-4903 | jamie.cooper@uga.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2019 | May 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Body Fat (%) |
Dual Energy X-Ray Absorptiometry |
| 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. |
| Waist Circumference (cm) | Measuring tape | 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. |
| Hip Circumference (cm) | Measuring tape | 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. |
| Concentration of Blood Triglyceride (mg/dL) | Fasting blood draw | 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. |
| Concentration of Blood High-density Lipoprotein (HDL) (mg/dL) | Fasting blood draw | 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. |
| Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL) | Fasting blood draw | 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. |
| Concentration of Blood Total Cholesterol (TC) (mg/dL) | Fasting blood draw | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Total Body Fat Percentage | Mean | Standard Deviation | percentage of body fat |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Hip Circumference | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglyceride | Mean | Standard Deviation | mg/dL |
|
| HDL-Cholesterol | Mean | Standard Deviation | mg/dL |
|
| LDL-Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Body Mass Index (BMI) | weight and height were combined to report BMI in kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Body Mass Index (BMI) (kg/m^2) | weight and height will be combined to report BMI in kg/m^2 | Posted | Mean | Standard Deviation | kg/m^2 | 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. |
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| Secondary | Body Fat (%) | Dual Energy X-Ray Absorptiometry | Posted | Mean | Standard Deviation | Percentage of body fat | 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. |
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| Secondary | Waist Circumference (cm) | Measuring tape | Posted | Mean | Standard Deviation | cm | 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. |
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| Secondary | Hip Circumference (cm) | Measuring tape | Posted | Mean | Standard Deviation | cm | 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. |
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| Secondary | Concentration of Blood Triglyceride (mg/dL) | Fasting blood draw | Posted | Mean | Standard Deviation | mg/dL | 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. |
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| Secondary | Concentration of Blood High-density Lipoprotein (HDL) (mg/dL) | Fasting blood draw | Posted | Mean | Standard Deviation | mg/dL | 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. |
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| Secondary | Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL) | Fasting blood draw | Posted | Mean | Standard Deviation | mg/dL | 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. |
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| Secondary | Concentration of Blood Total Cholesterol (TC) (mg/dL) | Fasting blood draw | Posted | Mean | Standard Deviation | mg/dL | 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. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |