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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

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.


Condition or disease Intervention/treatment Phase
Obesity Device: Daily self-weighing (DSW) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Daily Self-weighing and Holiday-associated Weight Gain in Adults
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: Control
Participants in this group received no intervention during t he holiday season
Experimental: Daily Self-Weighing (DSW)
Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season
Device: 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.
Other Name: DSW




Primary Outcome Measures :
  1. Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday [ 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. ]
    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 :
  1. Body Mass Index (BMI) (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. ]
    weight and height will be combined to report BMI in kg/m^2

  2. Body Fat (%) [ 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. ]
    Dual Energy X-Ray Absorptiometry

  3. Waist Circumference (cm) [ 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. ]
    Measuring tape

  4. Hip Circumference (cm) [ 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. ]
    Measuring tape

  5. Concentration of Blood Triglyceride (mg/dL) [ 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. ]
    Fasting blood draw

  6. Concentration of Blood High-density Lipoprotein (HDL) (mg/dL) [ 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. ]
    Fasting blood draw

  7. Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL) [ 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. ]
    Fasting blood draw

  8. Concentration of Blood Total Cholesterol (TC) (mg/dL) [ 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. ]
    Fasting blood draw



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718000


Locations
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United States, Georgia
University of Georgia - Department of Foods and Nutrition
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
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Principal Investigator: jamie.cooper@uga.edu Cooper, Ph.D. University of Georgia
  Study Documents (Full-Text)

Documents provided by Jamie Cooper, PhD, University of Georgia:

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Responsible Party: Jamie Cooper, PhD, Associate Professor and Graduate Coordinator, University of Georgia
ClinicalTrials.gov Identifier: NCT03718000     History of Changes
Other Study ID Numbers: STUDY00004735
First Posted: October 24, 2018    Key Record Dates
Results First Posted: June 13, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan is to share group averages through publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Jamie Cooper, PhD, University of Georgia:
Holiday weight gain
Daily self-weighing
Weight maintenance
Caloric titration method
Obesity
Overweight
Holiday season
Additional relevant MeSH terms:
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Weight Gain
Body Weight
Signs and Symptoms
Body Weight Changes