Collaborate2Lose: Involving Support Persons in Weight Management

NCT05448313 | Completed DMC

• 1 other identifier: IIR 21-101
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

weight loss; body weight changes; body weight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• obesity-specific quality of life

  72 weeks

Study Arms (2)

Dyadic intervention

EXPERIMENTAL

Veterans and their support person will participate in MOVE!

Behavioral: Dyadic intervention

Veteran-only intervention

ACTIVE COMPARATOR

Veterans will participate in MOVE! alone

Behavioral: Veteran-only intervention

Interventions

Dyadic intervention BEHAVIORAL

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.

Dyadic intervention

Veteran-only intervention BEHAVIORAL

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.

Veteran-only intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• aged 18 years or older
• willing to participate
• \< 2 errors on a validated 6-item cognitive screener
• ability to speak English

You may not qualify if:

• 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
• BMI \< 18.5 kg/m2
• active dementia or substance abuse
• impaired hearing
• chronic or unstable illness that would impair their ability to provide support

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight Changes; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Corrine I. Voils, PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: August 1, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)