HealthyTogether: RCT of a Dyadic Weight Management Intervention

NCT06619041 | Recruiting DMC

• 1 other identifier: IIR 23-040
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

Weight Loss; Weight Loss Programs; Social Support; Diet; Physical Activity; Virtual Medicine; Family; Dyadic

Outcome Measures

Primary Outcomes (1)

• Change in weight from Baseline to 6-months among Veterans

  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 Outcomes (9)

• Change in weight from Baseline to 6-months among Veterans (including EHR-data)

  6-months

• Change in weight from Baseline to 6-months among partners

  6-months

• Change in weight from Baseline to 12-months among Veterans (using EHR data)

  12-months

• Change in self-reported diet quality from Baseline to 6-months among Veterans

  6-months

• Change in self-reported diet quality from Baseline to 6-months among partners

  6-months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Behavioral: HealthyTogether

Usual Care Arm

NO INTERVENTION

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

Interventions

HealthyTogether BEHAVIORAL

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Kristen E. Gray, PhD MS BS

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen E Gray, PhD MS BS

CONTACT

(206) 764-2056; Kristen.Gray2@va.gov

Katherine D Hoerster, PhD MPH BA

CONTACT

(206) 277-4203; Katherine.Hoerster@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Brief, virtual, dyadic weight management intervention

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)