HealthyTogether Program for Obesity

Recruiting at 1 trial location

Overseen By Katherine D Hoerster, PhD MPH BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Bariatric surgery, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with obesity by testing a virtual weight management program called HealthyTogether, which involves both the Veteran and a family member or friend. The program spans 14 weeks and includes 8 sessions designed to encourage weight loss and improve health-related habits such as diet, exercise, and relationship quality. Veterans with a body mass index (BMI) of 30 or higher who can participate in online sessions during regular business hours may be suitable candidates for this study. As an unphased trial, this study provides Veterans the opportunity to enhance their health and relationships through a supportive, innovative program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that the HealthyTogether program is safe for weight management?

Research has shown that the HealthyTogether program is generally safe for participants. Studies on similar programs have found them to be well-tolerated, with no serious side effects reported. These programs aim to help people lose weight and improve health by involving family or friends.

In past evaluations, participants did not report major side effects. Instead, they mostly noticed improvements in health habits, such as better eating and increased activity. This suggests that the HealthyTogether program is a safe choice for those wanting to manage their weight with support from loved ones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HealthyTogether Program for obesity because it introduces a novel, virtual approach that involves both the individual and their partner or family member in the weight management process. Unlike traditional obesity treatments that often focus solely on the individual, this program leverages the power of social support to encourage lifestyle changes and improve outcomes. By integrating a brief, virtual, dyadic intervention with usual care, it aims to make weight management more accessible and sustainable, potentially leading to better adherence and results.

What evidence suggests that the HealthyTogether program is effective for weight management in Veterans?

Research has shown that the HealthyTogether program, which participants in this trial may receive, can aid in weight loss. One study found that participants improved their exercise and eating habits. These changes were linked to better social connections, which are important for maintaining weight loss goals. Another study found that people in the HealthyTogether program lost more weight than those receiving usual care after six months. This suggests that having a friend or family member join the program can significantly impact reaching weight loss goals. ^{2 4 5 6 7}

Who Is on the Research Team?

Kristen E. Gray, PhD MS BS

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for Veterans with overweight or obesity who haven't had significant weight loss in the VA's MOVE! Program. They must be willing to participate in an 8-week virtual program alongside a close family member or friend who will act as their support person.

Inclusion Criteria

I am a veteran aged 18-74 and have visited a primary care at the study site in the last year.

I have a BMI of 30 or higher, or my BMI is 25 or higher with a condition like high blood pressure, type 2 diabetes, or abnormal cholesterol levels.

I am over 18 and agree to join all study activities.

Exclusion Criteria

are pregnant, postpartum, nursing, or planning to become pregnant within 6 months

have severe hearing loss prohibiting participation

Veteran participants: Veterans are excluded if they are not fluent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HealthyTogether virtual weight management program over 8 weeks, including six hour-long and two 30-minute video sessions focusing on physical activity, diet, and relationship skills.

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for weight loss and health behavior changes at 6 months post-baseline.

6 months

Virtual follow-up assessments

Long-term Follow-up

Participants' weight and health behaviors are further monitored at 12 months to assess the durability of intervention effects.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HealthyTogether

Trial Overview The 'HealthyTogether' intervention is being tested, which is an 8-week virtual weight management program designed for Veterans and their chosen support person. The study aims to see if this dyadic approach helps with weight loss, improves physical activity and diet, and enhances relationship quality.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

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

Group II: Usual Care Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. withpower.com withpower.com/trial/phase-overweight-3-2025-b9c6a

HealthyTogether Program for Obesity Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE!

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612636/

Evidence review for effectiveness and acceptability of weight ... During the development of the protocol, change in BMI, BMI z-score and weight were identified as critical outcomes. Out of these outcomes, BMI z-score was ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03550248

Healthy Together Program Evaluation (Phase 3) A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09737-8

A RE-AIM evaluation of Healthy Together - BMC Public Health Effectiveness was demonstrated in reported improvements in physical activity, healthy eating, and strengthened social connections. HT was also ...

5. trialx.com trialx.com/clinical-trials/listings/300231/healthytogether-rct-of-a-dyadic-weight-management-intervention/?&radius=10&place=A&user_country=Concord%20N

HealthyTogether: RCT of a Dyadic Weight Management ... Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans (primary). Examine differences between ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06619041?cond=Obesity&term=weight-loss%20program;%20weight%20management%20program&aggFilters=funderType:nih%20fed,status:rec&rank=6

HealthyTogether: RCT of a Dyadic Weight Management ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4843192/

Healthy together Victoria and childhood obesity—a ... This research methodology describes the beginnings of a state-wide childhood obesity monitoring system that can evolve to regularly inform progress on reducing ...