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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Obesity; Overweight
• Intervention / Treatment: Behavioral: MOVE!+UP; Behavioral: MOVE!

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: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine D Hoerster, PhD MPH BA; Phone Number: (206) 277-4203; Email: Katherine.Hoerster@va.gov
• Study Contact Backup: Name: Nadiyah Sulayman, BA; Phone Number: (206) 277-4583; Email: Nadiyah.Sulayman@va.gov

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • Recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Katherine D Hoerster, PhD MPH BA; Phone Number: 206-277-4203; Email: Katherine.Hoerster@va.gov
      • Principal Investigator: Katherine D Hoerster, PhD MPH BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight (pounds) change	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)	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	Assess whether compared to control, intervention participants have greater improvements on 6- and 12-month PTSD symptom severity.	baseline and 6 and 12 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalized weight bias measured with "Modified Weight Bias Internalization Scale"	Assess whether compared to control, intervention participants have greater improvements on 6-month internalized weight bias.	baseline and 6 months post-baseline
Eating habits measured with "PACE" eating habits measure	Assess whether compared to control, intervention participants have greater improvements on 6-month eating habits	baseline and 6 months post-baseline
insomnia measured with the Insomnia Severity Index	Assess whether compared to control, intervention participants have greater improvements on 6-month insomnia severity.	baseline and 6 months post-baseline
depression severity measured with the Patient Health Questionnaire, 8-item version	Assess whether compared to control, intervention participants have greater improvements on 6-month depression symptoms.	baseline and 6 months post-baseline
night eating measured with the Night Eating Questionnaire	Assess whether compared to control, intervention participants have greater improvements on 6-month night eating symptoms.	baseline and 6 months post-baseline
social support for physical activity and healthy eating measured with adapted Sallis measure	Assess whether compared to control, intervention participants have greater improvements on 6-month social support for physical activity and healthy eating.	baseline and 6 months post-baseline
emotional eating measured with the Emotional Overeating Questionnaire	Assess whether compared to control, intervention participants have greater improvements on 6-month emotional eating.	baseline and 6 months post-baseline
diet quality measured with "Starting the Conversation"	Assess whether compared to control, intervention participants have greater improvements on 6-month diet quality.	baseline and 6 months post-baseline
one-week total light, moderate, and vigorous physical activity measured with accelerometers	Assess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based physical activity.	baseline and 6 months post-baseline
binge eating disorder criteria (yes vs. no) measured using an adapted Patient Health Questionnaire for DSM 5 criteria	Assess whether compared to control, intervention participants have lower prevalence of meeting binge eating disorder criteria at 6 months post-baseline.	baseline and 6 months post-baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• 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)?: NO

Drug and device information, study documents

• 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