NCT03718000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 13, 2019

Completed
Last Updated

June 1, 2022

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

October 17, 2018

Results QC Date

April 23, 2019

Last Update Submit

May 28, 2022

Conditions

Keywords

Holiday weight gainDaily self-weighingWeight maintenanceCaloric titration methodObesityOverweightHoliday season

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Body Mass Index (BMI) (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.

  • 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.

  • Waist Circumference (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.

  • Hip Circumference (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.

  • Concentration of Blood Triglyceride (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.

  • +3 more secondary outcomes

Study Arms (2)

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

Device: Daily self-weighing (DSW)

Interventions

DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.

Also known as: DSW
Daily Self-Weighing (DSW)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of at least 18.5 kg/m2
  • Recognizing or celebrating at least two holidays between November and January
  • Access to WiFi

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia - Department of Foods and Nutrition

Athens, Georgia, 30602, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jamie Cooper, Associate Professor
Organization
University of Georgia

Study Officials

  • jamie.cooper@uga.edu Cooper, Ph.D.

    University of Georgia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Graduate Coordinator

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 24, 2018

Study Start

November 1, 2017

Primary Completion

January 30, 2018

Study Completion

April 30, 2018

Last Updated

June 1, 2022

Results First Posted

June 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

The plan is to share group averages through publication.

Locations