Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Office of Biostatistics Research, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
BMJ Open. 2020 Dec 21;10(12):e040702. doi: 10.1136/bmjopen-2020-040702.
Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHealth PA intervention for AA women.
An mHealth intervention targeting AA women living in resource-limited Washington, DC communities was developed based on the socioecological framework for PA. Over 6 months, we will use a Sequential Multi-Assignment, Randomized Trial approach to compare the effects on PA of location-based remote messaging (named 'tailored-to-place') to standard remote messaging in an mHealth intervention. Participants will be randomised to a remote messaging intervention for 3 months, at which point the intervention strategy will adapt based on individuals' PA levels. Those who do not meet the PA goal will be rerandomised to more intensive treatment. Participants will be followed for another 3 months to determine the contribution of each mHealth intervention to PA level. This protocol will use novel statistical approaches to account for the adaptive strategy. Finally, effects of PA changes on CVD risk biomarkers will be characterised.
This protocol has been developed in partnership with a Washington, DC-area community advisory board to ensure feasibility and acceptability to community members. The National Institutes of Health Intramural IRB approved this research and the National Heart, Lung, and Blood Institute provided funding. Once published, results of this work will be disseminated to community members through presentations at community advisory board meetings and our quarterly newsletter.
NCT03288207.
尽管身体活动（PA）可降低心血管疾病（CVD）风险，但身体活动不足仍是一个紧迫的公共卫生问题，尤其是在美国的非裔美国（AA）女性中。需要针对生活在资源有限且缺乏身体活动基础设施的社区中的 AA 女性开展 PA 干预措施。移动健康（mHealth）技术可以增加获得 PA 干预的机会。我们描述了一种针对生活在资源有限的华盛顿特区社区中的 AA 女性的多层次、基于社区的 mHealth PA 干预措施的临床方案的制定过程。
基于 PA 的社会生态框架，为生活在资源有限的华盛顿特区社区中的 AA 女性制定了 mHealth 干预措施。在 6 个多月的时间里，我们将使用基于位置的远程信息传递（命名为“量身定制”）与 mHealth 干预措施中的标准远程信息传递比较对 PA 的影响，采用序贯多分配随机试验方法。参与者将被随机分配到远程信息传递干预措施中 3 个月，届时干预策略将根据个人的 PA 水平进行调整。未达到 PA 目标的人将被重新随机分配到更密集的治疗组。参与者将再随访 3 个月，以确定每个 mHealth 干预措施对 PA 水平的贡献。本方案将使用新的统计方法来考虑适应性策略。最后，将描述 PA 变化对 CVD 风险生物标志物的影响。
本方案是与华盛顿特区地区的社区咨询委员会合作制定的，以确保社区成员的可行性和可接受性。美国国立卫生研究院内部 IRB 批准了这项研究，美国国立心脏、肺和血液研究所提供了资金。一旦发表，这项工作的结果将通过在社区咨询委员会会议和我们的季度通讯中向社区成员介绍来进行传播。
NCT03288207。
