Using Partners to Enhance Long-Term Weight Loss

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT03801174
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.

Detailed Description

Couples will be randomized to a comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program. In months 7-18, all patients will receive a telephone-based weight loss maintenance intervention. In the partner-assisted arm only, partners will participate in the intervention, learning and practicing communication skills and support strategies. In months 19-24, intervention will be withdrawn to examine sustainability of effects.

Due to COVID-19, option of doing screening and outcome assessment visits and attending the group classes (including exercise) remotely via a video conference may be available. COVID-19 survey will be administered every 3 month starting at screening/enrollment visit.

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-11
• Study Start: 2019-01-15
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-20
• Results First Submitted: 2024-02-06
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Results First Posted: 2024-06-06
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Weight (kg)	24 months	Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint

Secondary Outcome Measures

Name	Time	Method
Caloric Intake (kcal)	24 months	average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Physical Activity	24 months	average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States