Collaborate2Lose: Involving Support Persons in Weight Management

NCT ID: NCT05448313

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-11-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dyadic intervention

Veterans and their support person will participate in MOVE!

Group Type EXPERIMENTAL

Dyadic intervention

Intervention Type 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.

Veteran-only intervention

Veterans will participate in MOVE! alone

Group Type ACTIVE_COMPARATOR

Veteran-only intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* 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

* 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
* living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corrine I. Voils, PhD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Locations

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William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IIR 21-101

Identifier Type: -

Identifier Source: org_study_id

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