HealthyTogether: RCT of a Dyadic Weight Management Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Collaborate2Lose: Involving Support Persons in Weight Management

NCT05448313

Obesity

COMPLETED NA

A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans

NCT05554601

Hypertension Obesity

ACTIVE_NOT_RECRUITING NA

Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans

NCT03563027

Physical Activity

COMPLETED NA

Improving Weight Management at the VA

NCT02626819

Obesity

COMPLETED NA

Randomized Controlled Trial Targeting Obesity-related Behaviors

NCT01584102

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The prevalence of overweight and obesity is more than 80% among VA users, increasing risk of morbidity and mortality. In 2006, VA nationally implemented the MOVE! Weight Management Program, an evidence-based behavioral weight management program. Effectiveness of MOVE! is suboptimal: \<20% of all participants and only 30% of those with intense and sustained participation achieve clinically meaningful weight loss. Furthermore, only 8-9% of eligible Veterans attend any MOVE! sessions and, among those who do, half attend only a single session. Taken together, \<2% of the 3.2 million eligible Veterans lose clinically meaningful weight in MOVE!. Therefore, additional weight management approaches are needed to address obesity at the VA population-level.

One strategy to improve behavioral weight management effectiveness is by leveraging social relationships. Social support improves weight management program initiation, retention, and short and long-term weight loss and is also a major driver of weight-related behaviors, such as physical activity and diet quality. However, social relationships can also impede weight management, for example, when close others (e.g., family and friends) undermine or do not support behavior change. The key to addressing this double-edged sword of social relationships may be through dyadic approaches that include close others in behavioral weight management with a focus on improving communication and relationship quality.

HealthyTogether is a brief, virtual weight management program for Veterans and a close other ("partner"). Over 14 weeks, individual dyads receive 8 hour-long video sessions with a clinician. Session content includes physical activity, diet, and weight management medication education; goal setting; and relationship and communication skills training and practice, informed by evidence-based dyadic treatments. This study is a two-site hybrid type I effectiveness-implementation randomized controlled trial with a primary focus on evaluating effectiveness of HealthyTogether and a secondary focus on understanding determinants of implementation. The aims of the trial are:

1. Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans (primary).
2. Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes, including health behaviors (i.e., diet, physical activity) and relationship quality.
3. Examine Veteran and partner contributions to changes in their own and each other's outcomes using dyadic analyses, informing potential future intervention targets.
4. Assess determinants of implementation, including cost, feasibility, acceptability, and appropriateness, guided by the Consolidated Framework for Implementation Research, to inform future implementation.

Considering the burden of overweight and obesity in VA and the limited reach and effectiveness of MOVE!, HealthyTogether has the potential to address multiple VA priorities: mitigate obesity-related chronic disease and involve family in Veterans' care. Study findings will inform VA National Center Health for Health Promotion and Disease Prevention efforts to expand effective, evidence-based weight management services for Veterans.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Brief, virtual, dyadic weight management intervention

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study staff who measure the primary outcome (weight) and conduct other outcome assessments at 6-months will remain masked to the treatment arm assignment of participants throughout the trial.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Arm

Receives the brief, virtual, dyadic HealthyTogether weight management intervention in addition to usual care.

Group Type EXPERIMENTAL

HealthyTogether

Intervention Type BEHAVIORAL

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

Usual Care Arm

Receives a brief letter with information about weight management and couples/family resources in addition to usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HealthyTogether

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes