HealthyTogether: RCT of a Dyadic Weight Management Intervention
Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 14 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Over 14 weeks, individual dyads receive 8 hour-long video sessions with a clinician."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a 14-week online weight management program with 8 sessions for Veterans with obesity and a family member or friend. It will look at weight loss, exercise, eating habits, and the quality of their relationship.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Veterans must have a VA primary care provider.
- Veterans must have a BMI of 30 or higher at enrollment. BMI is a measure of weight compared with height.
- Veterans must have a weight recorded in their VA record within 16 weeks before joining that shows a BMI of 30 or higher.
- Veterans must have a second valid weight recorded in their VA record within the past year.
- Both Veterans and support partners must be able to attend online sessions during regular business hours.
- Support partners must speak with the Veteran at least weekly.
- Support partners must live in the same state where the Veteran gets VA care.
Who can't join
- Both: Cannot speak English fluently, or have hearing loss severe enough to prevent taking part.
- Both: Have high alcohol use (a score of 8 or higher on the AUDIT-C alcohol screening test), receive hospice or palliative care, or live in a nursing home or assisted living facility. Hospice and palliative care focus on comfort and symptom relief.
- Support partners: Have a health condition that may limit their ability to take part.
- Veterans: Have dementia, kidney disease in its final stage, or a current or past eating disorder called anorexia or bulimia; or are getting cancer treatment other than for skin cancer.
- Veterans: Have ongoing drug or alcohol dependence, a recent suicide attempt, active psychosis (trouble knowing what is real), or a current behavior warning in their medical record.
- Veterans: Joined a clinical or research weight management program focused on behavior in the past 3 months; had weight-loss surgery in the past 2 years; or plan to have it within 6 months.
- Veterans: Are pregnant, have recently given birth, are breastfeeding, or plan to become pregnant within 6 months.
- Veterans: Get VA primary care at home, stayed in a hospital in the past 3 months, or weigh more than 440 pounds, the study scales' limit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (2)
CO
- Rocky Mountain Regional VA Medical Center, Aurora, CO · Aurora, CO 80045-7211Luis M Perez, PhD RD · Study contact · (720) 467-0757 · luis.perez2@va.govBriana Robustelli · Study contact · (720) 723-6872 · Briana.Robustelli@va.govLuis M Perez, PhD RD · Sub-investigatorMore trials in Aurora
WA
- VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, WA 98108-1532Jennifer L Jay · Study contact · (206) 277-1417 · jennifer.jay663@va.govSteven B Zeliadt, PhD MPH · Study contact · (206) 277-4175 · Steven.Zeliadt@va.govKristen E. Gray, PhD MS BS · Principal investigatorMore trials in Seattle