University of Wisconsin-Madison, School of Nursing, United States.
Marquette University, United States.
Contemp Clin Trials. 2018 Aug;71:80-87. doi: 10.1016/j.cct.2018.06.006. Epub 2018 Jun 9.
Osteoporosis is a prevalent and debilitating condition affecting >50% of post-menopausal women. Yet, a low percentage of women regularly engage in health promoting behaviors associated with osteoporosis prevention. Complex, multidimensional, m-Health interventions hold promise to effect engagement in health behavior change related to calcium and vitamin D intake, balance, core and leg strength, and physical activity.
Striving to be Strong study (R01NR013913-01) tests the efficacy of a research and theory based, patient centered, dynamically tailored intervention delivered via smart phone apps. Ecological Momentary Assessments (EMAs) enhance immediate feedback and complement traditional measures. The desired outcomes are the maintenance of osteoporosis self-management behaviors and a decrease in the loss of bone density over time. The Individual and Family Self-management Theory provided the conceptual foundation for the study. The sample consists of 290 healthy women between the ages of 40 and 60 with an anticipated attrition of 33%. This three group repeated measures Randomized Clinical Trial spans a 12-month time period. Data collected occurs via web site, smart-phone app, self-report, observation, and measures. Proximal (engagement in osteoporosis health behaviors) and distal (serum vitamin D, DXA, and body composition) outcomes are collected for testing of the efficacy of the intervention and theory evaluation.
Active and rigorous quality management processes continually evaluate enrollment and retention goals, functionality of the automated intervention delivery and data collection systems, EMAs, and dispersion of incentives.
骨质疏松症是一种常见且使人虚弱的疾病，影响超过 50%的绝经后妇女。然而，只有很少一部分女性定期参与与预防骨质疏松症相关的促进健康的行为。复杂的、多维的、移动健康干预措施有望促进与钙和维生素 D 摄入、平衡、核心和腿部力量以及身体活动相关的健康行为改变的参与。
Striving to be Strong 研究（R01NR013913-01）测试了一种基于研究和理论、以患者为中心、通过智能手机应用程序动态定制的干预措施的疗效。生态瞬时评估（EMA）增强了即时反馈，并补充了传统的测量方法。预期的结果是维持骨质疏松症自我管理行为，并随着时间的推移减少骨密度的流失。个体和家庭自我管理理论为该研究提供了概念基础。该样本由 290 名年龄在 40 岁至 60 岁之间的健康女性组成，预计会有 33%的人流失。这项三组成组重复测量随机临床试验跨越了 12 个月的时间。通过网站、智能手机应用程序、自我报告、观察和测量收集数据。收集近端（参与骨质疏松症健康行为）和远端（血清维生素 D、DXA 和身体成分）结果，以测试干预措施的疗效和理论评估。
积极和严格的质量管理流程不断评估招募和保留目标、自动化干预交付和数据收集系统、EMA 和激励措施的分配。
