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

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；根据最近的一项研究，86%的人在第一次去退伍军人管理局时超重或肥胖。然而，现有的退伍军人计划并不是为年轻退伍军人设计的，他们比年长的退伍军人更喜欢技术中介干预，而且可能还没有患上肥胖相关的慢性病。此外，与之前的退伍军人群体相比，OEF/OIF退伍军人中包括的女性比例相对较高。这些差异应该在为OEF/OIF退伍军人定制的生活方式干预中得到解决。以技术为中介的生活方式干预措施，包括持续、客观的家庭体力活动监测、自动互联网中介反馈和电子教练，增加了非退伍军人的体力活动并改善了减肥效果。当大规模实施时，这种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方案。由于现有的结构，如国家电子医疗记录系统，退伍军人保健系统处于有利地位，可以在全国范围内实施这种干预措施。这种干预措施可以集中管理并直接向退伍军人销售，利用规模经济，扩大干预范围，并减轻现有卫生保健团队的招聘负担。然而，除了一项试验性研究外，以预防为重点的技术中介体力活动计划，包括持续、客观的家庭体力活动监测、自动互联网或手机中介反馈以及电子教练，尚未针对OEF/IOF退伍军人进行定制和测试。该项目将测试针对OEF/OIF退伍军人的需求、偏好和人口统计而定制的以预防为重点的互联网健康生活方式Stay Strong计划的可行性和有效性。如果成功，Stay Strong计划可以作为一项全国性计划实施，以增强退伍军人管理局目前为需要支持以保持健康生活方式和预防未来疾病的OEF/OIF退伍军人的选择范围。该项目的具体目标是t 1)评估自动化的、集中管理的、互联网为媒介的体力活动干预措施对OEF/OIF退伍军人的体力活动的影响；2)评估Stay Strong对OEF/OIF退伍军人中体重减轻、抑郁和疼痛的次要结果的影响；以及3)根据每天中等到剧烈的体力活动分钟的主要结果，以及体重减轻、抑郁和疼痛的次要结果，测试按性别进行的Stay Strong干预的干预效果是否适度。在这项随机的等待名单对照研究中，OEF/OIF退伍军人将被随机分成等待名单控制组或留在强力干预组，为期一年。主要结果是在7天内平均每天中等强度到剧烈的体力活动的分钟数发生变化。体重减轻、疼痛和抑郁都是次要结果。由于性别缓和了体力活动干预的影响，我们将针对性别和样本过多的女性量身定做StayStrong。这项试验的创新之处在于，研究人员不会与参与者进行面对面的接触。所有参与者招募、资格筛选、知情同意、基线评估、随机化、干预交付和结果评估都将通过互联网或手机进行。在一个受约束的纵向数据模型中，基线体力活动被建模为因变量，并结合整个治疗组的共同基线平均值的约束，将测试干预组和等待名单组从基线到12个月的体力活动组之间的组间比较。

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.