Department of Health and Human Development, University of Pittsburgh, Pittsburgh, PA, United States of America.
Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States of America.
Contemp Clin Trials. 2021 Jul;106:106428. doi: 10.1016/j.cct.2021.106428. Epub 2021 May 7.
Sedentary behavior (SB) has recently been recognized as a strong risk factor for cardiovascular disease, with new guidelines encouraging adults to 'sit less, move more.' Yet, there are few randomized trials demonstrating that reducing SB improves cardiovascular health. The Effect of Reducing Sedentary Behavior on Blood Pressure (RESET BP) randomized clinical trial addresses this gap by testing the effect of a 3-month SB reduction intervention on resting systolic BP. Secondary outcomes include other BP measures, pulse wave velocity, plasma renin activity and aldosterone, and objectively-measured SB (via thigh-mounted activPAL) and physical activity (via waist-worn GT3X accelerometer). RESET BP has a targeted recruitment of 300 adults with desk jobs, along with elevated, non-medicated BP (systolic BP 120-159 mmHg or diastolic BP 80-99 mmHg) and physical inactivity (self-reported aerobic physical activity below recommended levels). The multi-component intervention promotes 2-4 fewer hours of SB per day by replacing sitting with standing and light-intensity movement breaks. Participants assigned to the intervention condition receive a sit-stand desk attachment, a wrist-worn activity prompter, behavioral counseling every two weeks (alternating in-person and phone), and twice-weekly automated text messages. Herein, we review the study rationale, describe and evaluate recruitment strategies based on enrollment to date, and detail the intervention and assessment protocols. We also document our mid-trial adaptations to participant recruitment, intervention deployment, and outcome assessments due to the intervening COVID-19 pandemic. Our research methods, experiences to date, and COVID-specific accommodations could inform other research studying BP and hypertension or targeting working populations, including those seeking remote methods.
久坐行为（SB）最近被认为是心血管疾病的一个强烈危险因素，新的指南鼓励成年人“少坐多动”。然而，很少有随机试验表明减少 SB 可以改善心血管健康。减少久坐行为对血压的影响（RESET BP）随机临床试验通过测试 3 个月的 SB 减少干预对静息收缩压的影响来解决这一差距。次要结局包括其他血压测量指标、脉搏波速度、血浆肾素活性和醛固酮，以及通过大腿佩戴的 activPAL 客观测量的 SB 和通过腰部佩戴的 GT3X 加速度计测量的身体活动。RESET BP 针对有久坐工作的 300 名成年人进行了有针对性的招募，这些成年人的血压升高（收缩压 120-159mmHg 或舒张压 80-99mmHg）且身体活动不足（自我报告的有氧体力活动低于推荐水平）。该多组分干预措施通过用站立和低强度运动休息代替久坐，每天减少 2-4 小时的 SB。被分配到干预组的参与者将获得一个可站立的办公桌附件、一个手腕佩戴的活动提示器、每两周一次的行为咨询（交替面对面和电话咨询），以及每周两次的自动短信。在此，我们回顾了研究的基本原理，根据迄今为止的入组情况描述和评估了招募策略，并详细介绍了干预和评估方案。我们还记录了由于 COVID-19 大流行而在试验中期对参与者招募、干预部署和结果评估所做的调整。我们的研究方法、迄今为止的经验以及针对 COVID-19 的特定调整措施可以为其他研究血压和高血压或针对工作人群的研究提供信息，包括那些寻求远程方法的研究。
