Clinical trial

HealthyTogether: RCT of a Dyadic Weight Management Intervention

Recruiting now · Not applicable · 1 countries · Registry ID NCT06619041

Recruiting nowNot applicableInterventional

What this study is about

Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE! Weight Management Program. Family and friends strongly influence a person's health behaviors and weight. Including a close family member or friend in weight management may improve weight management outcomes. This study will test whether an 14-week, 8-session virtual weight management program that includes Veterans and a support person (e.g., family member or friend) leads to weight loss. The investigators will also test whether the program leads to improvements in weight-related health behaviors, including physical activity and diet, and relationship quality.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionObesity, Overweight

Full registry criteria

Inclusion Criteria: Veteran participants: * 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: * Able to participate in virtual intervention sessions during regular business hours * Speak with Veteran at last weekly * Live in the same state where Veteran receives VA care 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 (within past 2 years) or plans to (within next 6 months) 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

Treatments and study arms

HealthyTogether

Behavioral

HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.

Primary outcomes

Change in weight from Baseline to 6-months among Veterans6-months

Weight is measured using a study-provided scale during a scheduled virtual study visit. Veterans will either (1) display the weight on the scale to study staff or (2) take a picture of the weight on the scale with a digital device and show the weight to study staff. For weight measurements at both timepoints, we will instruct participants to weigh themselves in light clothing and no shoes, with the scale on a hard, flat surface. We will record date and time of weight assessments and will make every attempt to collect follow-up weights at a similar time of day as baseline.