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

Trial Summary

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 data supports the effectiveness of the HealthyTogether treatment for obesity?

Research shows that structured programs involving regular support from health professionals can help people achieve meaningful weight loss and maintain it. For example, a study found that patients attending a weight management clinic lost an average of 6% of their body weight, and more frequent visits increased the chances of significant weight loss. ^{1 2 3 4 5}

How is the HealthyTogether treatment for obesity different from other treatments?

The HealthyTogether program is unique because it is a family-centered approach that focuses on supporting healthy eating and physical activity within community organizations, especially for families facing challenges like low income or isolation. Unlike traditional treatments, it emphasizes community involvement and real-world application to help manage obesity. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Kristen E. Gray, PhD MS BS

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of an interdisciplinary program for obesity management in Canada. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Can certified health professionals treat obesity in a community-based programme? A quasi-experimental study. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Using patient-reported outcome measures to assess the effectiveness of social media networking programs for people living with overweight and obesity to adopt a healthier lifestyle. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Association of clinically significant weight loss with number of patient visits and months of attendance at an Australian multidisciplinary weight management clinic. [2023]

5. Brazil pubmed.ncbi.nlm.nih.gov

Multiprofessional intervention and telenursing in the treatment of obese people in the COVID-19 pandemic: a pragmatic clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Healthy Weight Collaborative: using learning collaboratives to enhance community-based prevention initiatives addressing childhood obesity. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A RE-AIM evaluation of Healthy Together: a family-centred program to support children's healthy weights. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

A platform for population-based weight management: description of a health plan-based integrated systems approach. [2007]

9. England pubmed.ncbi.nlm.nih.gov

The development of a network for community-based obesity prevention: the CO-OPS Collaboration. [2021]