Clinical trial NCT05448313: Collaborate2Lose: Involving Support Persons in Weight Management
Official title: Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: weight loss
body weight changes
body weight
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Body weight (lb)
timeFrame: 72 weeks
Secondary outcomes:
measure: obesity-specific quality of life
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Corrine I. Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References: