Obesity
Conditions
Keywords
weight loss, body weight changes, body weight
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.
Interventions
BEHAVIORALDyadic 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.
BEHAVIORALVeteran-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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight (lb) | 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
| Measure | Time frame | Description |
|---|---|---|
| obesity-specific quality of life | 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 |
Countries
United States
Outcome results
None listed