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Tailored Weight Management Program for Veterans with PTSD

N/A
Waitlist Available
Led By Katherine D Hoerster, PhD MPH BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Baseline weight >440 lbs
or moderate to severe chronic, progressive neurologic conditions such as Dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 and 12 months post-baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new weight loss program, MOVE!+UP, for Veterans with PTSD who are overweight. The program combines weight loss support with therapy to address PTSD-related challenges. It aims to improve both weight and PTSD symptoms. MOVE!+UP is a tailored weight management program developed to address the unique barriers faced by veterans with PTSD, combining weight loss education with cognitive behavior therapy skills.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medication, typical side effects associated with drugs may not apply. However, participants might experience stress or discomfort related to changes in diet and exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is over 440 lbs.
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I have a moderate to severe long-term brain condition like dementia.
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I have had or plan to have weight loss surgery within 18 months.
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I cannot safely use a scale due to mobility issues or because I use assistive devices.
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I have PTSD with a trauma history and a score of 33 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 and 12 months post-baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 and 12 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
weight (pounds) change
Secondary study objectives
PTSD symptom severity on the PTSD Checklist for DSM-5
weight (pounds)
Other study objectives
Eating habits measured with "PACE" eating habits measure
Internalized weight bias measured with "Modified Weight Bias Internalization Scale"
binge eating disorder criteria (yes vs. no) measured using an adapted Patient Health Questionnaire for DSM 5 criteria
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MOVE!+UP (intervention)Experimental Treatment1 Intervention
usual care enhanced with MOVE!+UP (intervention)
Group II: MOVE! (control condition)Active Control1 Intervention
usual care enhanced with MOVE! (control condition)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD include cognitive-behavioral therapy (CBT), exposure therapy, and integrated approaches that address comorbid conditions like substance use disorders. CBT helps patients reframe negative thought patterns and develop coping strategies. Exposure therapy involves controlled exposure to trauma-related memories to reduce their emotional impact. Integrated approaches, such as Seeking Safety, focus on both PTSD and related issues like substance abuse, emphasizing safety and grounding techniques. These treatments are crucial for PTSD patients as they not only alleviate PTSD symptoms but also address barriers to healthy behaviors, such as weight management, by improving overall psychological functioning and reducing avoidance behaviors.
Theoretical and empirical issues in the treatment of post-traumatic stress disorder in Vietnam veterans.Providing a treatment rationale for PTSD: does what we say matter?

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,697 Total Patients Enrolled
Katherine D Hoerster, PhD MPH BAPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
2 Previous Clinical Trials
805 Total Patients Enrolled

Media Library

MOVE! Clinical Trial Eligibility Overview. Trial Name: NCT04563741 — N/A
Post-Traumatic Stress Disorder Research Study Groups: MOVE!+UP (intervention), MOVE! (control condition)
Post-Traumatic Stress Disorder Clinical Trial 2023: MOVE! Highlights & Side Effects. Trial Name: NCT04563741 — N/A
MOVE! 2023 Treatment Timeline for Medical Study. Trial Name: NCT04563741 — N/A
~35 spots leftby Oct 2025