Feasibility Study for Collaborate2Lose

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Partner support

• Registration Number: NCT05646771
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2023-03-13
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partner-Supported	Partner support	Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention.

Primary Outcome Measures

Name	Time	Method
Retention Rate for primary outcome	16 weeks	The outcome assessment retention rate at 16 weeks will be calculated as \[#of index participants who provide a weight at 16 weeks/number who provided a baseline weight\]. Our metric is at least 80% retention at 16 weeks.
Screening to enrollment ratio	baseline	We will calculate the screening to enrollment ratio. Our feasibility metric is 2:1 (i.e., 2 people start the phone screening in order to have one provide consent).

Secondary Outcome Measures

Name	Time	Method
Intervention adherence	14 weeks	Intervention adherence is calculated as the average number of group sessions attended by index participants.
Weight	16 weeks	Weight at 16 weeks is the primary endpoint. Veterans will be asked to weigh themselves during a virtual study visit, on a study-provided scale, while wearing light clothing (i.e., no outerwear such as jackets), with shoes removed.

Trial Locations

Locations (1)

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