RECRUITING

HealthyTogether: RCT of a Dyadic Weight Management Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-14
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06619041

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or higher.
  2. * Assigned to a VA primary care provider.
  3. * Have a weight measurement (BMI\>=30) recorded in the VA medical record within 16 weeks prior to enrollment.
  4. * Have a second, valid weight measurement recorded in the VA medical record within the prior year.
  5. * Have a BMI\>=30 at enrollment.
  6. * Able to participate in virtual intervention sessions during regular business hours.
  7. * Age 18 or higher.
  8. * Able to participate in virtual intervention sessions during regular business hours.
  9. * Speak with Veteran at last weekly.
  1. * not fluent in English
  2. * have severe hearing loss prohibiting participation
  3. * have a dementia diagnosis
  4. * have recently (within the past 3 months) participated in a clinical or research behavioral weight management program
  5. * have a history of or plans (within 6 months) to have bariatric surgery
  6. * are pregnant, postpartum, nursing, or planning to become pregnant within 6 months
  7. * are receiving cancer (non-skin) treatment
  8. * have drug or alcohol dependence not in remission, a recent suicide attempt, active psychosis, or an active behavior flag in the medical record
  9. * report high-levels of alcohol use (AUDIT-C score \>=8)
  10. * are receiving hospice or palliative care
  11. * are living in a nursing home or assisted living facility
  12. * are enrolled in VA home-based primary care
  13. * have end stage renal disease
  14. * have a current or past diagnosis of anorexia or bulimia
  15. * have had an inpatient hospitalization in the past 3 months
  16. * weigh more than 440 pounds (this is the upper limit of the study's scales)
  17. * not fluent in English
  18. * have severe hearing loss prohibiting participation
  19. * endorse having a health condition that may limit their ability to participate in the intervention
  20. * report high-levels of current alcohol use (AUDIT-C score \>=8)
  21. * are receiving hospice or palliative care
  22. * are living in a nursing home or assisted living facility

Contacts and Locations

Study Contact

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

Principal Investigator

Kristen E. Gray, PhD MS BS
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

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 Registration Dates

Study Start Date2025-07-14
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity
  • Overweight