MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- weight (pounds) change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
MOVE!+UP (intervention)
usual care enhanced with MOVE!+UP (intervention)
干预措施: MOVE!+UP (Behavioral)
MOVE! (control condition)
usual care enhanced with MOVE! (control condition)
干预措施: MOVE! (Behavioral)
结局指标
主要结局
weight (pounds) change
时间窗: 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.
Weight (Pounds) Change From Baseline to 6 Months Post-baseline
时间窗: 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.
次要结局
- weight (pounds)(baseline and 12 months post-baseline)
- PTSD symptom severity on the PTSD Checklist for DSM-5(baseline and 6 and 12 months post-baseline)
- 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)