NCT05448313
Completed
N/A
Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
ConditionsObesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- VA Office of Research and Development
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Body weight (lb)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.
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.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
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
- obesity-specific quality of life(72 weeks)
Study Sites (1)
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