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Behavioral Intervention

Integrated Weight Management Program for PTSD and Obesity

N/A
Recruiting
Led By Katherine L Hoerster, PhD, MPH
Research Sponsored by VA Puget Sound Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 months
Awards & highlights

Study Summary

This trial is testing a treatment to help Veterans with PTSD and high BMI. Participants get up to 16 psychotherapy visits over 6 months, as well as 2 assessment visits. Participation takes up to 6 months.

Who is the study for?
This trial is for Veterans with PTSD and obesity, having a BMI of at least 30. They must have experienced trauma, score ≥33 on the PCL-5 for PTSD, and be willing to engage in all study activities. Exclusions include recent or planned bariatric surgery, current pregnancy, non-English speakers, severe hearing loss without phone access, active participation in other weight or PTSD therapies.Check my eligibility
What is being tested?
The I MOVE!+UP program is being tested to see if it can help Veterans manage their weight while also receiving treatment for PTSD. It combines psychotherapy with behavioral weight management over six months alongside routine care. Participants will attend up to 16 therapy sessions and two assessment visits.See study design
What are the potential side effects?
Since this intervention involves psychotherapy and lifestyle changes rather than medication, side effects may include emotional discomfort from discussing traumatic events during therapy sessions and potential stress related to changing diet and exercise habits.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD symptoms
Weight
Secondary outcome measures
Blood pressure (diastolic)
Blood pressure (systolic)
Depression symptoms
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.Experimental Treatment1 Intervention
Single arm pilot trial.

Find a Location

Who is running the clinical trial?

VA Puget Sound Health Care SystemLead Sponsor
65 Previous Clinical Trials
227,783 Total Patients Enrolled
Katherine L Hoerster, PhD, MPHPrincipal InvestigatorVA Puget Sound Health Care System

Media Library

I MOVE!+UP (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05755100 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.
Post-Traumatic Stress Disorder Clinical Trial 2023: I MOVE!+UP Highlights & Side Effects. Trial Name: NCT05755100 — N/A
I MOVE!+UP (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755100 — N/A

Frequently Asked Questions

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

Does this investigation still have room for participants?

"Affirmative. Clinicaltrials.gov contains evidence that this medical experiment, initiated on December 1st 2023, is presently recruiting participants. 30 individuals are required to be enrolled from a single clinical trial site."

Answered by AI

What are the main aims of this medical experiment?

"The primary endpoint of this medical study, evaluated over a 6 month period, will be changes in PTSD symptoms. Secondary evaluations include self-reported dietary habits, internalized weight bias score and waist circumference measured during the research visit."

Answered by AI

What is the estimated number of participants in this trial?

"Affirmative, the information on clinicaltrials.gov attests that this trial is seeking participants at present. It was first listed on December 1st 2023 and has been amended as recently as March 2nd 2023. The study requires 30 patients to be recruited from a single site."

Answered by AI
~4 spots leftby Jul 2024