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I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD

Primary Purpose

PTSD, Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I MOVE!+UP
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime. - Experience of trauma, a score of ≥33, and meets criteria for the symptom domains. - Body Mass Index (BMI) of ≥ 30 kg/m2. - Willing to participate in all intervention and assessment activities Exclusion Criteria: - Not fluent in English, severe hearing loss, no phone access. - Current MOVE! participation (at least 2 sessions in the past 3 months.) - Current PTSD psychotherapy participation (at least 2 PE or CPT sessions in the past 3 months.) - Past year bariatric surgery or planning to have bariatric surgery in next 6 months. - Current pregnancy. - Based on clinical judgment, would be unable to participate because of a) acutely exacerbated substance use, mental health, or chronic medical conditions or b) moderate to severe chronic, progressive neurologic conditions such as Dementia.

Sites / Locations

  • VA Puget Sound Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.

Arm Description

Single arm pilot trial.

Outcomes

Primary Outcome Measures

Weight
in person weight taken during research visit
PTSD symptoms
PCL-5 (self-reported)

Secondary Outcome Measures

Depression symptoms
PhQ-8 (self-reported)
Insomnia severity
Insomnia severity index (self-reported)
Diet quality
Starting the Conversation (self-reported)
Social support for physical activity and healthy eating
Modified based on Sallis et al measure (self-reported)
Internalized weight bias
Internalized weight bias measure (self-reported)
Health-related quality of life
Sf-12 (self-reported)
Waist circumference
In person, taken during research visit
Blood pressure (systolic)
In person, taken during research visit
Blood pressure (diastolic)
In person, taken during research visit
Total cholesterol
In person, bloodwork taken during research visit
LDL cholesterol
In person, bloodwork taken during research visit
HDL cholesterol
In person, bloodwork taken during research visit
Triglycerides
In person, bloodwork taken during research visit
HbA1C
In person, bloodwork taken during research visit

Full Information

First Posted
February 8, 2023
Last Updated
March 2, 2023
Sponsor
VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT05755100
Brief Title
I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
Official Title
I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to test I MOVE!+UP, which integrates individual evidence-based psychotherapy for PTSD with behavioral weight management among Veterans with a Body Mass Index of at least 30 and meeting criteria for current PTSD. Participants will continue receiving routine primary care and psychiatric care management as indicated, in coordination with the I MOVE!+UP therapist. This study is being conducted to see whether I MOVE!+UP holds promise as a treatment for commonly co-occurring PTSD and high Body Mass Index. Participation will involve attending up to 16 psychotherapy visits that last approximately 1-2 hours over 6 months and attending 2 study assessment visits that last approximately 1-2 hours at enrollment and 6 months. Active participation will take up to approximately 6 months.
Detailed Description
Post-traumatic stress disorder (PTSD), prevalent among Veterans, puts Veterans at increased risk for obesity and related conditions. Veterans with PTSD lose less weight in VA's MOVE! weight management program, due to PTSD symptoms that interfere with activity and healthy diet. In addition, many Veterans who receive evidence-based PTSD treatment remain symptomatic. A behavioral weight loss program that augments standard PTSD care and targets PTSD-related weight loss barriers called MOVE!+UP was piloted and iteratively refined among 44 overweight Veterans with PTSD, and is currently being tested in an RCT. However, not all Veterans will participate in group-based treatment and prior work on integrated tobacco cessation with individual psychotherapy was quite impactful, and was particularly well-suited for coordinating augmentative medication management using shared decision-making. As such, we propose to conduct an uncontrolled pilot of an intervention called I MOVE!+UP. It will integrate MOVE!+UP into individual evidence-based psychotherapy (i.e.., Cognitive Processing Therapy) for PTSD for up to 6 months, augmented with evidence-based psychiatric and weight management medication management coordination. If I MOVE!+UP is acceptable, feasible, and proof-of-concept outcomes demonstrate potential benefit to weight and PTSD outcomes, we will apply for large-scale funding to test it in an RCT. I MOVE!+UP integrated behavioral intervention will be led by a psychotherapist (social worker, psychologist, or trainee in those disciplines). Because this care will be delivered within the context of routine mental health care, patients will be offered the opportunity for individualized pharmacotherapy for weight loss and psychiatric symptom management as part of their care plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Overweight and Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled pilot trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.
Arm Type
Other
Arm Description
Single arm pilot trial.
Intervention Type
Behavioral
Intervention Name(s)
I MOVE!+UP
Intervention Description
An individual psychotherapy that integrates behavioral weight management with evidence-based psychotherapy for PTSD (Cognitive Processing Therapy) for up to 6 months, augmented with evidence-based psychiatric and weight management medication management.
Primary Outcome Measure Information:
Title
Weight
Description
in person weight taken during research visit
Time Frame
change from baseline to 6 months
Title
PTSD symptoms
Description
PCL-5 (self-reported)
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Depression symptoms
Description
PhQ-8 (self-reported)
Time Frame
change from baseline to 6 months
Title
Insomnia severity
Description
Insomnia severity index (self-reported)
Time Frame
change from baseline to 6 months
Title
Diet quality
Description
Starting the Conversation (self-reported)
Time Frame
change from baseline to 6 months
Title
Social support for physical activity and healthy eating
Description
Modified based on Sallis et al measure (self-reported)
Time Frame
change from baseline to 6 months
Title
Internalized weight bias
Description
Internalized weight bias measure (self-reported)
Time Frame
change from baseline to 6 months
Title
Health-related quality of life
Description
Sf-12 (self-reported)
Time Frame
change from baseline to 6 months
Title
Waist circumference
Description
In person, taken during research visit
Time Frame
change from baseline to 6 months
Title
Blood pressure (systolic)
Description
In person, taken during research visit
Time Frame
change from baseline to 6 months
Title
Blood pressure (diastolic)
Description
In person, taken during research visit
Time Frame
change from baseline to 6 months
Title
Total cholesterol
Description
In person, bloodwork taken during research visit
Time Frame
change from baseline to 6 months
Title
LDL cholesterol
Description
In person, bloodwork taken during research visit
Time Frame
change from baseline to 6 months
Title
HDL cholesterol
Description
In person, bloodwork taken during research visit
Time Frame
change from baseline to 6 months
Title
Triglycerides
Description
In person, bloodwork taken during research visit
Time Frame
change from baseline to 6 months
Title
HbA1C
Description
In person, bloodwork taken during research visit
Time Frame
change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime. - Experience of trauma, a score of ≥33, and meets criteria for the symptom domains. - Body Mass Index (BMI) of ≥ 30 kg/m2. - Willing to participate in all intervention and assessment activities Exclusion Criteria: - Not fluent in English, severe hearing loss, no phone access. - Current MOVE! participation (at least 2 sessions in the past 3 months.) - Current PTSD psychotherapy participation (at least 2 PE or CPT sessions in the past 3 months.) - Past year bariatric surgery or planning to have bariatric surgery in next 6 months. - Current pregnancy. - Based on clinical judgment, would be unable to participate because of a) acutely exacerbated substance use, mental health, or chronic medical conditions or b) moderate to severe chronic, progressive neurologic conditions such as Dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine D Hoerster, PhD, MPH
Phone
206-277-4203
Email
katherine.hoerster@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alan D Wesley, BA
Phone
206-619-3689
Email
alan.wesley@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Hoerster, PhD, MPH
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-764-2053
First Name & Middle Initial & Last Name & Degree
Alan D Wesley, BA
Phone
206-619-3689
Email
alan.wesley@va.gov

12. IPD Sharing Statement

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I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD

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