HealthyTogether: Dyadic 14-week virtual weight-loss program for Veterans and a support person
Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether
NA · VA Office of Research and Development · NCT06619041
This program will see if a 14-week, eight-session virtual weight-loss program that includes Veterans and a close support person helps Veterans with obesity lose weight.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06619041 on ClinicalTrials.gov |
What this trial studies
HealthyTogether is a randomized interventional program that enrolls Veterans with obesity together with a close family member or friend to participate in an eight-session virtual weight-management program delivered over 14 weeks. Participants are randomized to the dyadic HealthyTogether intervention or a comparison condition and are followed for changes in body weight, physical activity, diet, and relationship quality. The intervention emphasizes behavior change skills, social support, and improved communication within the dyad to promote sustained weight-related behavior changes. Outcomes are measured using VA medical-record weights and validated surveys of diet, activity, and relationship functioning.
Who should consider this trial
Good fit: Ideal candidates are Veterans with BMI ≥30 who receive VA primary care, can join virtual sessions during business hours, and have a close support person willing to participate.
Not a fit: Patients unlikely to benefit include those with dementia or severe hearing loss, recent or planned bariatric surgery, recent participation in another behavioral weight program, pregnant or nursing individuals, those not fluent in English, or Veterans without a regular close support person.
Why it matters
Potential benefit: If successful, the program could help more Veterans achieve clinically meaningful weight loss and improve diet, physical activity, and relationships with close others.
How similar studies have performed: Prior research shows social-support and dyadic approaches can improve program initiation, retention, and both short- and long-term weight loss, though brief virtual dyadic programs in Veterans are less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Veteran participants: * Age 18 or higher. * Assigned to a VA primary care provider. * Have a weight measurement (BMI\>=30) recorded in the VA medical record within 16 weeks prior to enrollment. * Have a second, valid weight measurement recorded in the VA medical record within the prior year. * Have a BMI\>=30 at enrollment. * Able to participate in virtual intervention sessions during regular business hours. Partner participants: * Age 18 or higher. * Able to participate in virtual intervention sessions during regular business hours. * Speak with Veteran at last weekly. Exclusion Criteria: Veterans are excluded if: * not fluent in English * have severe hearing loss prohibiting participation * have a dementia diagnosis * have recently (within the past 3 months) participated in a clinical or research behavioral weight management program * have a history of or plans (within 6 months) to have bariatric surgery * are pregnant, postpartum, nursing, or planning to become pregnant within 6 months * are receiving cancer (non-skin) treatment * have drug or alcohol dependence not in remission, a recent suicide attempt, active psychosis, or an active behavior flag in the medical record * report high-levels of alcohol use (AUDIT-C score \>=8) * are receiving hospice or palliative care * are living in a nursing home or assisted living facility * are enrolled in VA home-based primary care * have end stage renal disease * have a current or past diagnosis of anorexia or bulimia * have had an inpatient hospitalization in the past 3 months * weigh more than 440 pounds (this is the upper limit of the study's scales) Partners are excluded if: * not fluent in English * have severe hearing loss prohibiting participation * endorse having a health condition that may limit their ability to participate in the intervention * report high-levels of current alcohol use (AUDIT-C score \>=8) * are receiving hospice or palliative care * are living in a nursing home or assisted living facility
Where this trial is running
Aurora, Colorado and 1 other locations
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (RECRUITING)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Kristen E. Gray, PhD MS BS — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Kristen E Gray, PhD MS BS
- Email: Kristen.Gray2@va.gov
- Phone: (206) 764-2056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Overweight, Weight Loss, Weight Loss Programs, Social Support, Diet, Physical Activity, Virtual Medicine