- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563741
MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: 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. The fully developed MOVE!+UP is led by a psychologist and a Veteran peer support counselor, who provide complementary expertise. It includes 16 group sessions with 90 minutes of general weight loss support, coupled with Cognitive Behavior Therapy skills to address PTSD-specific barriers. Each session also includes a 30-minute community walk to address hypervigilance-based activity barriers and enhance classroom-based learning. Veterans receive two individual dietician visits, and counseling calls as needed. 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! program. They also reported substantial PTSD symptom reduction. Treatment targets like eating behaviors, activity, and insomnia also improved. MOVE!+UP effectiveness must be tested in a randomized trial.
Significance/Impact: MOVE!+UP is timely and efficient, simultaneously addressing physical and mental health of a priority Veteran group. MOVE!+UP is positioned to address HSR&D priorities by promoting mental health and improving PTSD symptoms, access to care, and whole health. This study is aligned with HSR&D and ORD methodological priorities by using a hybrid type 1 trial. This study's cost and utilization analyses, and systematic identification of implementation barriers and facilitators, would place effectiveness findings in context and facilitate rapid translation to the field if MOVE!+UP is effective. This study will also provide insights about ways that general MOVE! and PTSD care can be enhanced to improve reach and effectiveness.
Innovation: MOVE!+UP is the first weight loss program designed to address obesity in Veterans with PTSD.
Specific Aims: This study proposes to enroll Veterans with PTSD who are classified as overweight or with obesity and who are engaged in PTSD care. They will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention), and is guided by three aims: 1) Test whether intervention participants have greater 6-month weight loss (primary outcome), and 6- and 12-month PTSD symptom reduction and 12-month weight loss (secondary exploratory outcomes), relative to controls; 2) Assess whether compared to control, intervention participants have greater improvements on 6-month treatment targets: physical activity, eating behavior, insomnia, depression, and social support; 3) Estimate intervention and control condition costs and utilization, and identify MOVE!+UP implementation barriers and facilitators, to contextualize Aim 1 and inform future implementation.
Methodology: Hybrid type 1 trial with 164 Veterans with PTSD who are classified as overweight or with obesity and are currently enrolled in PTSD care.
Implementation/Next Steps: This hybrid type 1 trial will provide data needed to prepare a MOVE!+UP implementation package for broader VA implementation if MOVE!+UP is effective. If it is not effective, Aims 2 and 3 will help understand how overweight Veterans with PTSD could be better supported in the future. Implementation activities would be coordinated with existing local, VISN, and national operational partners.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108-1532
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime experience of trauma and a score of 33
- Overweight or obesity based on Body Mass Index (BMI) of 25 kg/m2
- Primary Care Provider or other physician approval
- Willing to participate in all intervention or control and assessment activities
- Enrolled in PTSD treatment
- Must have active VA Puget Sound Health Care System medical record.
Exclusion Criteria:
- Not fluent in English, severe hearing loss, no phone access
- Current MOVE! participation
- Current pregnancy
Based on clinical judgment, would be unable to participate because of:
- acutely exacerbated substance use, mental health, or chronic medical conditions
- or moderate to severe chronic, progressive neurologic conditions such as Dementia
- had bariatric surgery within the last 12 months or plan to undergo bariatric surgery within the next 6 months.
- Report they cannot safely weigh themselves using the mailed study scale due to mobility issues or use of assistive devices
- Baseline weight >440 lbs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MOVE!+UP (intervention)
usual care enhanced with MOVE!+UP (intervention)
|
behavioral weight management intervention developed for Veterans with PTSD
|
|
Active Comparator: MOVE! (control condition)
usual care enhanced with MOVE! (control condition)
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standard VA weight management intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (Pounds) Change From Baseline to 6 Months Post-baseline
Time Frame: baseline and 6 months post-baseline
|
This study's primary aims is to test whether intervention participants have greater 6-month weight loss, relative to controls.
|
baseline and 6 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (Pounds) Change From Baseline to 12 Months Post-baseline
Time Frame: baseline and 12 months post-baseline
|
Test whether intervention participants have greater long-term (12-month) weight loss, relative to controls.
|
baseline and 12 months post-baseline
|
|
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month PTSD symptom severity.
Total scores range 0 - 80, where higher scores are indicative of greater severity.
|
baseline and 6 months post-baseline
|
|
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline
Time Frame: baseline and 12 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 12-month PTSD symptom severity.
Total scores range 0 - 80, where higher scores are indicative of greater severity.
|
baseline and 12 months post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insomnia Measured With the Insomnia Severity Index Change From Baseline to 6 Months Post-baseline
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month insomnia severity.
Total scores range 0 - 28, with higher scores indicating more acute symptoms of insomnia.
|
baseline and 6 months post-baseline
|
|
Average Daily Light, Moderate, and Vigorous Physical Activity Measured With Accelerometers (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based light, moderate, and vigorous physical activity.
This variable combines all forms of physical activity into a single measure.
|
baseline and 6 months post-baseline
|
|
Average Daily Moderate and Vigorous Physical Activity Measured With Accelerometers (Change From Baseline to 6-months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based moderate and vigorous physical activity.
This measure combines only moderate and vigorous activity because this is the higher activity threshold to achieve and more closely aligns with the type of activity recommended in standard activity recommendations.
|
baseline and 6 months post-baseline
|
|
Depression Severity Measured With the Patient Health Questionnaire, 8-item Version (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month depression symptoms.
Total scores range 0 - 24 where higher scores indicate greater depression severity.
|
baseline and 6 months post-baseline
|
|
Internalized Weight Bias Measured With "Modified Weight Bias Internalization Scale" (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month internalized weight bias.
The measure was changed only slightly to add one item reflecting positive body image: "I love my shape and size."
Scores for items were summed and then averaged, with those for positive body image reverse-scored.
Scores ranged from 1-7, with higher scores representing worse weight bias internalization.
|
baseline and 6 months post-baseline
|
|
Eating Habits Measured With "PACE" Eating Habits Measure (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month eating habits.
Scores for items were summed and then averaged, with a summary score range from 0-4, with higher scores indicating worse eating habits.
|
baseline and 6 months post-baseline
|
|
Social Support for Physical Activity (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month social support for physical activity.
Scores for items were summed and then averaged.
Scores ranged from 0-4, with higher scores indicating better support.
|
baseline and 6 months post-baseline
|
|
Social Support for Healthy Eating (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month social support for healthy eating.
Scores for items were summed and then averaged.
Scores ranged from 0-4, with higher scores indicating better support.
|
baseline and 6 months post-baseline
|
|
Discouragement for Healthy Eating (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month discouragement for healthy eating.
Scores for items were summed and then averaged.
Scores ranged from 0-4, with higher scores indicating greater discouragement.
|
baseline and 6 months post-baseline
|
|
Discouragement for Physical Activity (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month discouragement for physical activity.
Scores for items were summed and then averaged.
Scores ranged from 0-4, with higher scores indicating greater discouragement.
|
baseline and 6 months post-baseline
|
|
Night Eating Measured With the Night Eating Questionnaire (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month night eating symptoms.
Scores for items were summed.
The overall scale score ranged from 0-24, with higher scores indicating greater night eating.
|
baseline and 6 months post-baseline
|
|
Emotional Eating Measured With the Emotional Overeating Questionnaire (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month emotional eating.
Scores for items were summed and then averaged.
Scores ranged from 0-4, with higher scores indicating greater emotional eating.
|
baseline and 6 months post-baseline
|
|
Diet Quality Measured With "Starting the Conversation" (Change From Baseline to 6 Months Post-baseline)
Time Frame: baseline and 6 months post-baseline
|
Assess whether compared to control, intervention participants have greater improvements on 6-month diet quality.
Scores for items were summed.
The overall score for the scale ranged from 0-16, with higher scores indicating worse diet quality.
|
baseline and 6 months post-baseline
|
|
Binge Eating (Yes vs. no at 6 Months Post-baseline) Measured Using an Adapted Patient Health Questionnaire for DSM 5 Criteria
Time Frame: 6 months post-baseline
|
Assess whether compared to control, intervention participants have lower prevalence of engaging in binge eating at 6 months post-baseline.
Those reporting current binge eating behavior (with or without engaging in purging) were designated as yes, binge eating, and the outcome prevalence is presented for those who do engage in binge eating.
Those who did not endorse binge eating behavior were designated as no.
|
6 months post-baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Katherine D Hoerster, PhD MPH BA, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publications and helpful links
General Publications
- Hoerster KD, Tanksley L, Sulayman N, Bondzie J, Brier M, Damschroder L, Coggeshall S, Houseknecht D, Hunter-Merrill R, Monty G, Saelens BE, Sayre G, Simpson T, Wong E, Nelson K. Testing a tailored weight management program for veterans with PTSD: The MOVE! + UP randomized controlled trial. Contemp Clin Trials. 2021 Aug;107:106487. doi: 10.1016/j.cct.2021.106487. Epub 2021 Jun 16.
- Hoerster KD, Sulayman N, Hunter-Merrill R, Coggeshall S, Tanksley L, Brier M, Donovan L, Fennell T, Gray K, Evans DH, Rosendahl K, Saelens BE, Simpson T, Nelson KM. Enhanced Weight Management Program for Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261904. doi: 10.1001/jamanetworkopen.2026.1904.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 18-230
- HX002755-01A2 (Other Grant/Funding Number: U.S. Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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