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

NCT04563741 | Completed Results DMC

• 2 other identifiers: IIR 18-230HX002755-01A2
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight (Pounds) Change From Baseline to 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 Outcomes (3)

• Weight (Pounds) Change From Baseline to 12 Months Post-baseline

  baseline and 12 months post-baseline

• PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline

  baseline and 6 months post-baseline

• PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline

  baseline and 12 months post-baseline

Other Outcomes (14)

• Insomnia Measured With the Insomnia Severity Index Change From Baseline to 6 Months Post-baseline

  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)

  baseline and 6 months post-baseline

• Average Daily Moderate and Vigorous Physical Activity Measured With Accelerometers (Change From Baseline to 6-months Post-baseline)

  baseline and 6 months post-baseline

Study Arms (2)

MOVE!+UP (intervention)

EXPERIMENTAL

usual care enhanced with MOVE!+UP (intervention)

Behavioral: MOVE!+UP

MOVE! (control condition)

ACTIVE COMPARATOR

usual care enhanced with MOVE! (control condition)

Behavioral: MOVE!

Interventions

MOVE!+UP BEHAVIORAL

behavioral weight management intervention developed for Veterans with PTSD

MOVE!+UP (intervention)

MOVE! BEHAVIORAL

standard VA weight management intervention

MOVE! (control condition)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

Location

Related Publications (2)

• 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.

  PMID: 34144246 RESULT

• 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.

  PMID: 41893847 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Overweight; Obesity

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Prompted by the COVID-19 pandemic, we modified our procedures from previously-planned in-person assessments to hold visits via video, which at times impeded visualization of participants' weights. Also due to the pandemic, we modified our intervention (and control groups) to be delivered by video, which may have affected their effectiveness; however, prior work has shown that this is unlikely to be the case.

Results Point of Contact

• Title: Katherine Hoerster, PhD, MPH (Principal Investigator)
• Organization: VA Puget Sound Health Care System, Seattle Division

Katherine.Hoerster@va.gov

206-277-4203

Study Officials

• Katherine D Hoerster, PhD MPH BA

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)