OBJECTIVE: The HARMONY Study is designed to test a culturally tailored mindfulness-based stress management intervention to address SWS, contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals. The study will help AAW build on their strengths to promote cardiometabolic health by enhancing positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk.
METHODS: This two-arm, randomized-controlled trial will test the effects of two group-based, online interventions. HARMONY 1 includes culturally-tailored exercise and nutrition education. HARMONY 2 includes mindfulness-based stress reduction, exercise, and nutrition education. We aim to recruit 200 AAW ≥ 18 years old with CM risk.
RESULTS: Primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) are being collected at baseline and 4-, 8-, and 12-months post-intervention. Intent-to-treat, data analytic approaches will be used to test group differences for the primary outcomes.
CONCLUSIONS: This study is the first to address culturally-nuanced stress phenomena in AAW (SWS, network stress, and contextualized stress) using culturally-tailored stress management, exercise, and nutrition educational approaches to reduce biobehavioral CM risk among AAW. Quantitative and qualitative results will inform the development of scalable and sustainable CM risk-reduction programming for AAW.
BACKGROUND: The Multiple PIs registered the clinical trial (Identifier: NCT04705779) and reporting of summary results in ClinicalTrials.gov in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, within the required timelines.
目的:和谐研究旨在测试一种文化定制的基于正念的压力管理干预措施,以解决SWS,语境压力,网络压力是坚持健康运动和饮食目标的潜在障碍。这项研究将帮助AAW利用他们的优势,通过加强积极的重新评估来促进心脏代谢健康。自我调节,和自我效能感作为对抗慢性应激诱导的生物行为发病率和死亡风险的保护因素。
方法:这种双臂,随机对照试验将测试两组的效果,在线干预。和谐1包括文化定制的锻炼和营养教育。和谐2包括基于正念的减压,锻炼,营养教育。我们的目标是招募200名年龄≥18岁的有CM风险的AAW。
结果:主要结果(活动记录和类胡萝卜素水平)和次要结果(身体组成,炎症标志物,葡萄糖代谢,和压力)正在基线和4-,8-,干预后12个月。意向治疗,数据分析方法将用于测试主要结果的群体差异。
结论:这项研究是第一个解决AAW中文化上细微的压力现象的研究(SWS,网络应力,和情境化压力)使用文化定制的压力管理,锻炼,和营养教育方法,以降低AAW中的生物行为CM风险。定量和定性结果将为AAW的可扩展和可持续的CM风险降低计划的开发提供信息。
背景:根据NIH资助的临床试验信息传播政策,多个PI注册了临床试验(标识符:NCT04705779)并在ClinicalTrials.gov中报告了汇总结果,在规定的时间内。