Collaborate2Lose: Involving Support Persons in Weight Management

Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss

This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Dyadic intervention; Behavioral: Veteran-only intervention

Detailed Description

Dyads comprising a Veteran with obesity and a cohabitating adult will be randomized to participate in a weight management program by the Veteran alone or with their support person. The program will be delivered by research staff using a secure video platform. Outcomes will be assessed remotely at baseline and weeks 24, 48, and 72, with 72 weeks as the primary endpoint.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2254
      • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient inclusion criteria

• aged 18 years or older
• BMI >= 30 kg/m2
• at least one visit with a VA primary care provider within the past year
• weight <=420 lb due to study scale limits
• have been cohabitating and have daily contact over the past 6 months with an adult who can provide support (e.g., spouse/domestic partner, sibling, adult child, friend, family member) for the next 18 months
• desire to lose weight
• able to stand for weight measurements without assistance
• < 2 errors on a validated 6-item cognitive screener
• ability to speak English
• agrees to attend visits per protocol
• individual email-address
• access to hardware and internet connection to enable participation with approved virtual platform Partner inclusion criteria
• aged 18 years or older
• willing to participate
• < 2 errors on a validated 6-item cognitive screener
• ability to speak English
• individual email address

Exclusion Criteria:

Patient exclusion criteria

• active dementia or substance abuse
• history of bariatric surgery or planning to have bariatric surgery in the next 18 months
• pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
• weight loss >= 10 lb in the month prior to screening
• living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
• unable to control what food is purchased and / or served
• impaired hearing
• current use of weight loss medications
• chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization)
• participation in VA MOVE! weight management program in the past 6 months
• current participation in a research or clinical program focusing on lifestyle change
• vomits once or more per week Partner exclusion criteria
• BMI < 18.5 kg/m2
• active dementia or substance abuse
• impaired hearing
• chronic or unstable illness that would impair their ability to provide support
• living in a facility such as a nursing home, skilled nursing facility, or assisted living facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyadic intervention; Veterans and their support person will participate in MOVE!	Behavioral: Dyadic intervention; Dyads comprising a Veteran and cohabitating support person will participate in the 16-week VA MOVE! weight loss program delivered by video platform. They will then participate in 6 group sessions focused on weight maintenance skills. Communication skills will be taught throughout the intervention.
Active Comparator: Veteran-only intervention; Veterans will participate in MOVE! alone	Behavioral: Veteran-only intervention; Veterans will participate in a 72-week weight management program delivered by video platform. 16 sessions will address weight loss, with 6 additional ones addressing weight loss maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (lb)	Measured on a calibrated, digital scale to the nearest 0.1 lb, assessed every 24 weeks with 72 weeks as the primary endpoint	72 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obesity-specific quality of life	Measured on the 31-item, reliable, valid Impact of Weight on Quality of Life-Lite scale. Items are rated on a 5-point graded response scale ranging from never true to always true. Possible scores range from 31 to 155, with greater scores corresponding to greater impairment in quality of life. The measure will be administered every 24 weeks with 72 weeks as the primary endpoint	72 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Corrine I. Voils, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: weight loss; body weight; body weight changes
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Body Weight; Body Weight Changes
• Other Study ID Numbers: IIR 21-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No