Skip to main content
OpenTrials
Completed

NCT Number: NCT05448313

Collaborate2Lose: Involving Support Persons in Weight Management

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Body weight (lb)

    Time frame: 72 weeks

    Measured on a calibrated, digital scale to the nearest 0.1 lb, assessed every 24 weeks with 72 weeks as the primary endpoint

Secondary outcomes

  1. obesity-specific quality of life

    Time frame: 72 weeks

    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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.