Clinical trial NCT03718000: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Holiday weight gain
Daily self-weighing
Weight maintenance
Caloric titration method
Obesity
Overweight
Holiday season
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday
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.
Secondary outcomes:
measure: Body Mass Index (BMI) (kg/m^2)
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.
measure: Body Fat (%)
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.
measure: Waist Circumference (cm)
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.
measure: Hip Circumference (cm)
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.
measure: Concentration of Blood Triglyceride (mg/dL)
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.
measure: Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)
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.
measure: Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)
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.
measure: Concentration of Blood Total Cholesterol (TC) (mg/dL)
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.
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia - Department of Foods and Nutrition
state: Georgia
Study officials:
affiliation: University of Georgia
name: jamie.cooper@uga.edu Cooper, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.