Back to resultsDaily Self-weighing and Holiday-associated Weight Gain in Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily self-weighing (DSW)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Holiday weight gain, Daily self-weighing, Weight maintenance, Caloric titration method, Obesity, Overweight, Holiday season
Eligibility Criteria
Inclusion Criteria:
- BMI of at least 18.5 kg/m2
- Recognizing or celebrating at least two holidays between November and January
- Access to WiFi
Exclusion Criteria:
- Current eating disorder, history of an eating disorder
- Involvement in a current weight loss and/or exercise program
- Pregnancy or nursing
- Any medications or chronic diseases affecting metabolism or body weight
Sites / Locations
- University of Georgia - Department of Foods and Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Daily Self-Weighing (DSW)
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Body Mass Index (BMI) (kg/m^2)
weight and height will be combined to report BMI in kg/m^2
Body Fat (%)
Dual Energy X-Ray Absorptiometry
Waist Circumference (cm)
Measuring tape
Hip Circumference (cm)
Measuring tape
Concentration of Blood Triglyceride (mg/dL)
Fasting blood draw
Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
Fasting blood draw
Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
Fasting blood draw
Concentration of Blood Total Cholesterol (TC) (mg/dL)
Fasting blood draw
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03718000
Brief Title
Daily Self-weighing and Holiday-associated Weight Gain in Adults
Official Title
Daily Self-weighing and Holiday-associated Weight Gain in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Holiday weight gain, Daily self-weighing, Weight maintenance, Caloric titration method, Obesity, Overweight, Holiday season
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group received no intervention during t he holiday season
Arm Title
Daily Self-Weighing (DSW)
Arm Type
Experimental
Arm Description
Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season
Intervention Type
Device
Intervention Name(s)
Daily self-weighing (DSW)
Other Intervention Name(s)
DSW
Intervention Description
DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.
Primary Outcome Measure Information:
Title
Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday
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.
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI) (kg/m^2)
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.
Title
Body Fat (%)
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.
Title
Waist Circumference (cm)
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.
Title
Hip Circumference (cm)
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.
Title
Concentration of Blood Triglyceride (mg/dL)
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.
Title
Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
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.
Title
Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
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.
Title
Concentration of Blood Total Cholesterol (TC) (mg/dL)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI of at least 18.5 kg/m2
Recognizing or celebrating at least two holidays between November and January
Access to WiFi
Exclusion Criteria:
Current eating disorder, history of an eating disorder
Involvement in a current weight loss and/or exercise program
Pregnancy or nursing
Any medications or chronic diseases affecting metabolism or body weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jamie.cooper@uga.edu Cooper, Ph.D.
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia - Department of Foods and Nutrition
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The plan is to share group averages through publication.
Citations:
PubMed Identifier
31119881
Citation
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.
Results Reference
derived
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Daily Self-weighing and Holiday-associated Weight Gain in Adults
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