Daily Self-weighing and Holiday-associated Weight Gain in Adults

Obesity Clinical Trial

Official title:

Daily Self-weighing and Holiday-associated Weight Gain in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718000
• Other study ID #: STUDY00004735
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2019
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Georgia - Department of Foods and Nutrition	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.