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中文摘要
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描述(由申请人提供):在美国,只有不到一半的成年女性从事推荐水平的体力活动。因此,他们患心脏病、中风、高血压、糖尿病、某些癌症和过早死亡的风险增加。鉴于移动的电话技术的快速发展和用户数量的不断增加,我们为久坐女性开发了一种基于交互式移动的电话的身体活动干预(基于美国心脏协会为久坐女性开发的选择移动计划)。我们在一项为期3周的前后研究中评估了这种干预措施的可行性和可接受性,在这项研究中,我们有快速的招募,无损耗,高依从性(95%的计步器依从性和85%的手机日记依从性),以及显著增加的步数。我们现在建议进行一项随机对照试验,以评估基于移动的手机的体力活动干预在3个月内增加体力活动的有效性。192名久坐不动的女性将以2:1的比例随机分配到为期3个月的基于移动的手机的体力活动干预组或对照组。两组的参与者都将收到一个计步器和一部移动的手机,并被要求戴上计步器,每天晚上睡觉前通过手机日记发送他们的总步数。只有干预组的参与者才能通过手机接收“选择移动”程序,包括每日提示、每周视频剪辑、定制反馈和自我监测。主要结果将是每天的总步数(通过计步器测量)。次要结果将是每天的有氧步数(也通过计步器测量)和自我报告的7天身体活动回忆。为了深入了解如何在完成3个月计划后最大限度地发挥持续体力活动的潜力,干预组中完成体力活动计划的女性将进一步随机分配至6个月维持干预-PLUS计划(计步器加手机日记)或6个月维持干预-常规计划(仅计步器)。与所有受试者继续在各自的随机化组中进行的常规维持随访不同,将受试者重新随机化至维持干预-常规组或维持干预-加组将使我们能够检查维持方法的“剂量-反应”(如果干预有效)。我们还将探讨潜在的中介因素(体力活动,自我效能,社会支持,结果期望和决策平衡)和调节因素(BMI和年龄)对体力活动变化的作用。如果证明有效,基于移动的电话的干预的一个主要优势是,它可能被管理到大量的妇女。
英文摘要
DESCRIPTION (provided by applicant): Fewer than half of adult women in the US engage in recommended levels of physical activity. As a consequence, they are at increased risk of heart disease, stroke, hypertension, diabetes, certain cancers, and premature mortality. Given the rapid growth of mobile phone technology and the increasing number of users, we developed an interactive mobile phone-based physical activity intervention for sedentary women (based on the Choose to Move program developed by the American Heart Association for sedentary women). We assessed the feasibility and acceptability of this intervention in a 3-week pre-post study in which we had rapid enrollment, no attrition, high compliance (95% compliance with a pedometer and 85% compliance with a cell phone diary), and a significantly increased step count. We now propose to conduct a randomized, controlled trial to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity over a 3-month period. 192 sedentary women will be randomized in a 2-to-1 ratio to a 3-month mobile phone-based physical activity intervention group or to a control group. Participants in both groups will receive a pedometer and a mobile phone and will asked to wear a pedometer and to send their total number of steps through a cell phone diary before going to bed each night. Only participants in the intervention group will receive the Choose to Move program through their cell phones via daily prompts, weekly video clips, and customized feedback and self-monitoring. The primary outcome will be total steps per day (as measured by the pedometer). Secondary outcomes will be the aerobic steps per day (also measured by the pedometer) and self-reported 7-day physical activity recall. To provide insight into how best to maximize the potential for sustained physical activity after completion of the 3-month program, women in the intervention group who complete the physical activity program will be further randomized into a 6-month maintenance intervention-PLUS program (pedometer plus cell phone diary) or to a 6-month maintenance intervention-REGULAR program (pedometer only). Unlike a conventional maintenance follow-up in which all subjects continue in their respective randomization arms, re-randomizing subjects into either a maintenance intervention-REGULAR group or a maintenance intervention-PLUS group will allow us to examine the "dose-response" of the maintenance methods if the intervention is effective. We will also explore the role of potential mediating factors (physical activity, self-efficacy, social support, outcome expectation, and decisional balance) and moderating factors (BMI and age) on changes in physical activity. If proven effective, a major advantage of a mobile phone-based intervention is that it could potentially be administered to a large number of women.
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