HealthyTogether: RCT of a Dyadic Weight Management Intervention

August 28, 2026 updated by: VA Office of Research and Development

Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
        • Sub-Investigator:
          • Luis M Perez, PhD RD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • Recruiting
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Principal Investigator:
          • Kristen E. Gray, PhD MS BS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Receives the brief, virtual, dyadic HealthyTogether weight management intervention in addition to usual care.
Behavioral: HealthyTogether
HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.
No Intervention: Usual Care Arm
Receives a brief letter with information about weight management and couples/family resources in addition to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight from Baseline to 6-months among Veterans
Time Frame: 6-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.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight from Baseline to 6-months among partners
Time Frame: 6-months
Weight is measured using a study-provided scale during a scheduled virtual study visit. Partners 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. 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.
6-months
Change in weight from Baseline to 12-months among Veterans (using EHR data)
Time Frame: 12-months
Baseline weight is measured using a study-provided scale during a scheduled virtual study visit. To examine durability of intervention effects while minimizing participant burden, we will also obtain EHR-based weights at 12 months, using weights collected 365 days +/- 90 days post-baseline among only Veterans.
12-months
Change in self-reported diet quality from Baseline to 6-months among Veterans
Time Frame: 6-months
This outcome is measured by self-report using the eight-item Starting the Conversation measure.
6-months
Change in self-reported diet quality from Baseline to 6-months among partners
Time Frame: 6-months
This outcome is measured by self-report using the eight-item Starting the Conversation measure.
6-months
Change in physical activity from Baseline to 6-months among Veterans
Time Frame: 6-months
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
6-months
Change in physical activity from Baseline to 6-months among partners
Time Frame: 6-months
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
6-months
Change in relationship quality from Baseline to 6 months among Veterans
Time Frame: 6-months
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
6-months
Change in relationship quality from Baseline to 6 months among partners
Time Frame: 6-months
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
6-months
Change in weight from Baseline to 6-months among Veterans (using EHR-data)
Time Frame: 6-months
We will collect supplementary EHR-based weights from for all Veteran participants. We will use the EHR weight closest to 182 days +/- 60 days post-baseline. While the primary outcome is limited to Veterans with study team measured weight, secondary analyses will be conducted among all participants with available weight outcomes (staff verified and/or EHR-based).
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Kristen E. Gray, PhD MS BS, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 23-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Such requests will be evaluated in terms of protecting potential intellectual property value and rights of VA and its employees, collaborators and research sponsors, and any other proprietary or security concerns, including protection of Personal Identifiable Information (PII) and Protected Health Information (PHI), terms of Confidentiality Agreements or other such restrictions and protections.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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