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Tailored Weight Management Program for Veterans with PTSD

N/A

Recruiting

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

Study Summary

This trial will test whether a weight loss program that specifically targets PTSD will help Veterans with PTSD lose weight and improve their PTSD symptoms.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 and 12 months post-baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

weight (pounds) change

Secondary outcome measures

PTSD symptom severity on the PTSD Checklist for DSM-5

weight (pounds)

Other outcome measures

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

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)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,120 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research still admitting participants?

"As of now, clinicaltrials.gov lists this medical study as actively recruiting participants. The trial was first posted on October 1st 2020 and has undergone its most recent update in August 2nd 2022."

Answered by AI

What is the upper boundary of participants in this experiment?

"Affirmative. The information published on clinicaltrials.gov displays that recruitment for this study is currently underway. It was initially posted on October 1st 2020 and most recently modified on August 2nd 2022, with the aim to recruit 164 participants from one site location."

Answered by AI