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MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563741
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Posttraumatic Stress Disorder (PTSD) is common among Veterans and results in poor psychological functioning, quality of life, and physical health. This includes having disproportionately high rates of obesity, in part due to PTSD symptoms interfering with physical activity and healthy diet. Unfortunately, Veterans with PTSD have poorer weight loss outcomes than those without PTSD in VA's existing weight management program, MOVE!. Based on pilot work, it appears that a weight management program that augments standard PTSD care and targets PTSD-related barriers to weight loss improves weight and PTSD symptoms. Whether it improves these issues more than standard VA care is in need of study, which is the focus of the proposed research. The proposed study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered, tailored weight loss program may efficiently benefit both physical and mental health of Veterans with PTSD, addressing standard care limitations.

Condition or disease Intervention/treatment Phase
PTSD Overweight Obesity Behavioral: MOVE!+UP Behavioral: MOVE! Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a hybrid type 1 trial with 164 Veterans with PTSD who are classified as overweight or with obesity, and who are currently enrolled in PTSD care. Participants will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention).
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will not know the treatment assignment. Because this is a behavioral intervention, with supervision provided by the lead investigator, the participants, care providers, and investigators will not be blinded.
Primary Purpose: Treatment
Official Title: MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: MOVE!+UP (intervention)
usual care enhanced with MOVE!+UP (intervention)
Behavioral: MOVE!+UP
behavioral weight management intervention developed for Veterans with PTSD

Active Comparator: MOVE! (control condition)
usual care enhanced with MOVE! (control condition)
Behavioral: MOVE!
standard VA weight management intervention




Primary Outcome Measures :
  1. weight (pounds) change [ 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.


Secondary Outcome Measures :
  1. weight (pounds) [ Time Frame: baseline and 12 months post-baseline ]
    Test whether intervention participants have greater long-term (12-month) weight loss, relative to controls.

  2. PTSD symptom severity on the PTSD Checklist for DSM-5 [ Time Frame: baseline and 6 and 12 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6- and 12-month PTSD symptom severity.

  3. Internalized weight bias measured with "Modified Weight Bias Internalization Scale" [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month internalized weight bias.

  4. Eating habits measured with "PACE" eating habits measure [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month eating habits


Other Outcome Measures:
  1. physical activity measured with accelerometers [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based physical activity.

  2. insomnia measured with the Insomnia Severity Index [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month insomnia severity.

  3. depression severity measured with the Patient Health Questionnaire, 8-item version [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month depression symptoms.

  4. binge eating measured using an adapted Patient Health Questionnaire for DSM 5 criteria [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month binge eating symptoms.

  5. night eating measured with the Night Eating Questionnaire [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month night eating symptoms.

  6. social support for physical activity and healthy eating measured with adapted Sallis measure [ 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 and healthy eating.

  7. emotional eating measured with the Emotional Overeating Questionnaire [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month emotional eating.

  8. diet quality measured with "Starting the Conversation" [ Time Frame: baseline and 6 months post-baseline ]
    Assess whether compared to control, intervention participants have greater improvements on 6-month diet quality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563741


Contacts
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Contact: Katherine D Hoerster, PhD MPH BA (206) 277-4203 Katherine.Hoerster@va.gov
Contact: Nadiyah Sulayman, BA (206) 277-4583 Nadiyah.Sulayman@va.gov

Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Katherine D Hoerster, PhD MPH BA    206-277-4203    Katherine.Hoerster@va.gov   
Principal Investigator: Katherine D Hoerster, PhD MPH BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Katherine D Hoerster, PhD MPH BA VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04563741    
Other Study ID Numbers: IIR 18-230
HX002755-01A2 ( Other Grant/Funding Number: U.S. Department of Veterans Affairs )
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Overweight
Body Weight