Recruiting

Weight Management Program

Sponsor:

VA Office of Research and Development

Code:

NCT06619041

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HealthyTogether

Study Details

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

Study ID

NCT06619041

Start date

Jul 14, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

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

no intervention: Usual Care Arm

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

Interventions

HealthyTogether

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

Primary outcome measure

  • Change in weight from Baseline to 6-months among Veterans [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Kristen E Gray, PhD MS BS

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

Katherine D Hoerster, PhD MPH BA

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

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Luis M Perez, PhD RD

(720) 467-0757luis.perez2@va.gov

Briana Robustelli

(720) 723-6872Briana.Robustelli@va.gov

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

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Jennifer L Jay

(206) 277-1417jennifer.jay663@va.gov

Steven B Zeliadt, PhD MPH

(206) 277-4175Steven.Zeliadt@va.gov

Principal Investigator:

Kristen E. Gray, PhD MS BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 1, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-01.