Stay Strong: A physical activity program for Afghanistan and Iraq Veterans

保持坚强：阿富汗和伊拉克退伍军人的体育活动计划

• 批准号: 8486713
• 负责人: CAROLINE R. RICHARDSON
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8486713
• 关键词: Address; Afghanistan; Body Weight decreased; Caring; Cells; Cellular Phone; Chronic Disease; Computerized Medical Record; Controlled Study; Data Security; Disease; Effectiveness; Eligibility Determination; Feedback; Future; Gender; Health system; Healthcare; Healthcare Systems; Home environment; Informed Consent; Internet; Intervention; Iraq; Life Style; Marketing; Mediating; Medical Care Team; Mental Depression; Modeling; Monitor; Obesity; Outcome Assessment; Overweight; Pain; Participant; Patients; Physical activity; Pilot Projects; Population; Positioning Attribute; Prevention; Privacy; Provider; Randomized; Reporting; Sampling; Structure; System; Technology; Testing; Veterans; Visit; Woman; Work; arm; cohort; comparison group; control trial; cost effective; data modeling; demographics; design; eHealth; healthy lifestyle; high risk; improved; innovation; intervention effect; lifestyle intervention; monitoring device; patient safety; preference; prevent; primary outcome; programs; screening; secondary outcome; therapy design

DESCRIPTION (provided by applicant): Veterans from Afghanistan and Iraq (OEF/OIF) are at high risk for becoming overweight and obese; 86% were overweight or obese at their first visit to the VA as reported in one recent study. However, existing VA programs are not designed for younger Veterans who are more comfortable with technology-mediated interventions than older Veterans and who may not yet have developed obesity related chronic diseases. Additionally, OEF/OIF Veterans include a relatively high percentage of women compared to previous Veteran cohorts. These differences should be addressed in lifestyle interventions customized to OEF/OIF Veterans. 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. The VA health care system is in a strong position to implement such interventions on a national scale because of existing structures such as a national electronic medical records system. Such interventions can be centrally administered and marketed directly to Veterans, capitalizing on economies of scale, expanding intervention reach, and reducing the burdening of recruitment on the existing health care team. However, with the exception of one pilot study, prevention focused technology-mediated physical activity programs that include continuous, objective home monitoring of physical activity, automated internet or cell-phone mediated feedback, and e-coaching have not been customized and tested for OEF/IOF Veterans. 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 Veterans. If successful, the Stay Strong program could be implemented as a national program to augment the VA's current panel of options for OEF/OIF Veterans who need support to maintain a healthy lifestyle and prevent future disease. The specific aims of this project are t 1) evaluate the impact of an automated, centrally administered, internet-mediated, physical activity intervention, Stay Strong, on physical activity among OEF/OIF Veterans; 2) evaluate the impact of Stay Strong on the secondary outcomes of weight loss, depression and pain among OEF/OIF Veterans; and 3) test for moderation of the intervention effect of the Stay Strong intervention by gender with respect to the primary outcome of minutes of moderate to vigorous physical activity per day, as well as secondary outcomes of weight loss, depression and pain. In this randomized, waitlist controlled study, OEF/OIF Veterans will be randomized into either a waitlist control arm or the Stay Strong intervention arm for one year. The primary outcome is change in minutes of moderate to vigorous physical activity per day averaged over 7 days. Weight loss, pain and depression are secondary outcomes. Because gender moderates the impact of physical activity interventions, we will tailor StayStrong on gender and over-sample women. The trial is innovative in that study staff will have no face-to-face contact with participants. All participant recruitment, eligibility screening, informed consent, baseline assessment, randomization, intervention delivery and outcome assessment will be internet or cell-phone mediated. A constrained longitudinal data model in which baseline physical activity is modeled as a dependent variable in conjunction with the constraint of a common baseline mean across the treatment group will test for a between- group comparison in physical activity from baseline to 12 months in the intervention and waitlist groups.

描述（由申请人提供）： 来自阿富汗和伊拉克的退伍军人（OEF/OIF）超重和肥胖的风险很高;最近的一项研究报告显示，86%的人在第一次访问VA时超重或肥胖。然而，现有的VA计划不是为年轻的退伍军人设计的，他们比年长的退伍军人更适应技术介导的干预措施，并且可能尚未发展出肥胖相关的慢性疾病。 此外，与以前的退伍军人群体相比，“持久自由行动”/“伊拉克自由行动”退伍军人中妇女的比例相对较高。这些差异应在为OEF/OIF退伍军人定制的生活方式干预中加以解决。 技术介导的生活方式干预，包括持续，客观的家庭监测身体活动，自动互联网介导的反馈和电子教练，增加身体活动，改善非退伍军人人群的体重减轻。如果大规模实施，这些干预措施是面对面改变生活方式干预措施的低成本但有效的替代办法。退伍军人管理局的卫生保健系统是在一个强大的地位，在全国范围内实施这种干预措施，因为现有的结构，如国家电子病历系统。这些干预措施可以集中管理，直接向退伍军人销售，利用规模经济，扩大干预范围，减少现有医疗保健团队的招聘负担。然而，除了一项试点研究，预防为重点的技术介导的身体活动计划，包括连续的，客观的家庭监测身体活动，自动互联网或手机介导的反馈，以及电子教练尚未定制和测试OEF/IOF退伍军人。 该项目将测试以预防为重点，以互联网为媒介的健康生活方式的可行性和有效性，该计划是根据OEF/OIF退伍军人的需求，偏好和人口统计数据定制的。如果成功的话，“保持坚强”计划可以作为一个国家计划实施，以增加退伍军人事务部目前为OEF/OIF退伍军人提供的选择，这些退伍军人需要支持来保持健康的生活方式和预防未来的疾病。该项目的具体目标是：1）评估自动化、集中管理、互联网介导的身体活动干预措施Stay Strong对OEF/OIF退伍军人身体活动的影响; 2）评估Stay Strong对OEF/OIF退伍军人体重减轻、抑郁和疼痛等次要结果的影响;和3）测试按性别划分的“保持坚强”干预措施的干预效果的适度性，主要结果是每天中等强度到剧烈体力活动的分钟数，以及次要结果是体重减轻、抑郁和疼痛。 在这项随机、等待名单对照研究中，OEF/OIF退伍军人将被随机分配到等待名单对照组或Stay Strong干预组，为期一年。主要结果是7天内平均每天中度至剧烈体力活动分钟数的变化。体重减轻、疼痛和抑郁是次要结局。由于性别会缓和身体活动干预的影响，我们将根据性别和过度抽样的女性量身定制StayStrong。该试验具有创新性，因为研究工作人员不会与受试者进行面对面的接触。所有受试者招募、资格筛选、知情同意、基线评估、随机化、干预实施和结局评估均将通过互联网或手机进行。将基线体力活动建模为因变量的约束纵向数据模型结合治疗组间共同基线平均值的约束，将检验干预组和等待组从基线至12个月体力活动的组间比较。