Clinical trial NCT04563741: MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
Official title: MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Overweight
Obesity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-24
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a hybrid type 1 trial with 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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: weight (pounds) change
timeFrame: baseline and 6 months post-baseline
Secondary outcomes:
measure: weight (pounds)
timeFrame: baseline and 12 months post-baseline
measure: PTSD symptom severity on the PTSD Checklist for DSM-5
timeFrame: baseline and 6 and 12 months post-baseline
Other outcomes:
measure: insomnia measured with the Insomnia Severity Index
timeFrame: baseline and 6 months post-baseline
measure: average daily light, moderate, and vigorous physical activity measured with accelerometers
timeFrame: baseline and 6 months post-baseline
measure: Internalized weight bias measured with "Modified Weight Bias Internalization Scale"
timeFrame: baseline and 6 months post-baseline
measure: depression severity measured with the Patient Health Questionnaire, 8-item version
timeFrame: baseline and 6 months post-baseline
measure: average daily moderate and vigorous physical activity measured with accelerometers
timeFrame: baseline and 6 months post-baseline
measure: Eating habits measured with "PACE" eating habits measure
timeFrame: baseline and 6 months post-baseline
measure: binge eating (yes vs. no) measured using an adapted Patient Health Questionnaire for DSM 5 criteria
timeFrame: baseline and 6 months post-baseline
measure: night eating measured with the Night Eating Questionnaire
timeFrame: baseline and 6 months post-baseline
measure: social support for physical activity and healthy eating measured with adapted Sallis measure
timeFrame: baseline and 6 months post-baseline
measure: emotional eating measured with the Emotional Overeating Questionnaire
timeFrame: baseline and 6 months post-baseline
measure: diet quality measured with "Starting the Conversation"
timeFrame: baseline and 6 months post-baseline
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Katherine D Hoerster, PhD MPH BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.