Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 1
- 主要终点
- Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
研究概览
简要总结
This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.
This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.
详细描述
Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese. However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts. Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations. When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system. Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans. Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals. Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OEF/OIF/OND Veteran
- •Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system
- •Interested in starting a physical activity program in the next 30 days
- •Access to a computer with an internet connection and a working USB port.
- •A smartphone running a compatible iOS or Android operating system.
- •Younger than Age 65
排除标准
- •Veteran self-reports that a health care provider has told the patient that it is currently unsafe to exercise in an unsupervised or unmonitored setting. (Can become eligible with written medical clearance).
- •History of eating disorders or a BMI < 20
- •Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.
研究组 & 干预措施
Stay Strong w/coaching
participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
干预措施: Stay Strong w/coaching (Behavioral)
Stay Strong
participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
干预措施: Stay Strong (Behavioral)
结局指标
主要结局
Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
时间窗: Change from Baseline in objectively monitored physical activity at one year after randomization
Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.
次要结局
- Change in Weight as Measured From VA Medical Record(Change from Baseline in weight at one year after randomization)
- Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)(Change from Baseline Depression score at one year after randomization)
- Change in Pain Measures as Assessed by the VA Pain Intensity(Change from Baseline in Pain measures at one year after randomization)