Tailored Weight Management Program for Veterans with PTSD

Overseen By Nadiyah Sulayman, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Dementia, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: 16

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new weight management program, specifically designed for Veterans with PTSD, can improve weight loss and PTSD symptoms more effectively than the standard program. Veterans often encounter unique challenges, such as PTSD symptoms, that complicate weight loss. This study will compare a program called MOVE!+UP with the regular MOVE! program to identify which is more effective. Veterans who have PTSD, are overweight, and are already enrolled in PTSD treatment at the VA Puget Sound Health Care System may be suitable candidates for this trial. As an unphased study, this trial provides Veterans with a unique opportunity to contribute to research that could lead to more effective weight management solutions tailored to their needs.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that most people find the MOVE!+UP program easy to follow. In past studies, over 70% of Veterans in the program lost about 5% of their starting weight, with an average weight loss of 14 pounds. Participants expressed high satisfaction with the program. No major side effects have been reported, indicating that the program is safe and effective for helping Veterans with PTSD manage their weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tailored weight management program for veterans with PTSD because it offers a personalized approach that enhances the existing MOVE! program. The MOVE!+UP intervention is designed to provide more customized support by incorporating additional strategies that address the unique challenges faced by veterans with PTSD, which are not typically covered by standard weight management programs. This innovative enhancement aims to improve engagement and effectiveness by tailoring interventions to individual needs, potentially leading to better health outcomes for this specific population.

What evidence suggests that this trial's treatments could be effective for weight management in Veterans with PTSD?

Research has shown that the MOVE!+UP program, available to participants in this trial, aids in significant weight loss and improves PTSD symptoms. In earlier studies, over 70% of participants lost about 5% of their starting weight, averaging a weight loss of 14 pounds. Participants also reported high satisfaction with the program. MOVE!+UP tackles specific challenges, such as PTSD-related obstacles to healthy living, making it more effective for weight management than the standard MOVE! program, which serves as the control condition in this trial. ^{1 2 3 4 5}

Who Is on the Research Team?

Katherine D Hoerster, PhD MPH BA

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 PTSD who are overweight or obese, have experienced trauma, and score at least 33 on the PCL-5. They must be enrolled in PTSD treatment, approved by a physician to participate, and not planning bariatric surgery soon. Excluded are those with severe hearing loss, no phone access, current MOVE! participation or pregnancy.

Inclusion Criteria

My weight is over 440 lbs.

I have a moderate to severe long-term brain condition like dementia.

I have had or plan to have weight loss surgery within 18 months.

Exclusion Criteria

Current MOVE! participation

Current pregnancy

Not fluent in English, severe hearing loss, no phone access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MOVE!+UP program, which includes 16 group sessions with weight loss support and Cognitive Behavior Therapy skills, along with community walks and dietician visits.

6 months

16 group sessions, 2 individual dietician visits, counseling calls as needed

Follow-up

Participants are monitored for weight loss and PTSD symptom reduction after the treatment phase.

6 months

Long-term Follow-up

Participants are assessed for long-term weight loss and PTSD symptom severity.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MOVE!
• MOVE!+UP

Trial Overview The study tests a tailored weight management program called MOVE!+UP against the standard VA care program MOVE!. It aims to see if addressing PTSD-related barriers within the weight management program can improve both weight and PTSD symptoms more effectively than standard care.

How Is the Trial Designed?

Group I: MOVE!+UP (intervention) Experimental Treatment 1 Intervention

usual care enhanced with MOVE!+UP (intervention)

Group II: MOVE! (control condition) Active Control 1 Intervention

usual care enhanced with MOVE! (control condition)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. hsrd.research.va.gov hsrd.research.va.gov/publications/vets_perspectives/0920-MOVE-UP-Behavioral-Weight-Management-Program-for-Veterans-with-PTSD.cfm

MOVE!+UP Behavioral Weight Management Program for ... More than 70% of Veteran participants lost approximately 5% of baseline weight, with an average decrease of 14 lbs. PTSD symptom severity as measured on the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04563741

MOVE!+UP: Testing a Tailored Weight Management ... The cohort receiving the final MOVE!+UP package reported high satisfaction and had better weight loss outcomes than Veterans with PTSD in the general MOVE!

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002238

The MOVE! + UP randomized controlled trial We developed and piloted a behavioral weight management program called MOVE! + UP that targets PTSD-related weight loss barriers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7478932/

Development of a Tailored Behavioral Weight Loss Program ... MOVE!+UP was developed to address unique barriers to physical activity, healthy eating, and weight loss for Veterans with PTSD by supplementing weight loss ...

5. trial.medpath.com trial.medpath.com/clinical-trial/e610e6ed2995c35f/nct04563741-move-up-weight-management-program-veterans-ptsd

Testing a Tailored Weight Management Program for Veterans ... The cohort receiving the final MOVE!+UP package reported high satisfaction and had better weight loss outcomes than Veterans with PTSD in the general MOVE!