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Completed

NCT Number: NCT04563741

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

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.

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Key information

Conditions

PTSD Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MOVE!+UP

Behavioral

behavioral weight management intervention developed for Veterans with PTSD

MOVE!

Behavioral

standard VA weight management intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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