Kidney Health Research Institute, Geisinger, Danville, Pennsylvania, USA.
Center for Professionalism, Geisinger, Danville, Pennsylvania, USA.
BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.
Weight loss, consumption of a Dietary Approaches to Stop Hypertension dietary pattern, reduced sodium intake and increased physical activity have been shown to lower blood pressure (BP). Use of web-based tools and telehealth to deliver lifestyle counselling could be potentially scalable solutions to improve BP through behavioural modification though limited data exists to support these approaches in clinical practice.
This randomised controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour SBP in patients with overweight/obesity (body mass index ≥25 kg/m) and 24-hour SBP 120-160 mm Hg. All participants receive personalised recommendations to improve dietary quality based on a web-based Food Frequency Questionnaire, access to an online comprehensive weight management programme and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 12 weeks in 24-hour SBP. Secondary outcomes include changes from baseline in 24-hour diastolic BP, daytime SBP, nighttime SP, daytime diastolic BP, nighttime diastolic BP, total Healthy Eating Index-2015 score, weight, waist circumference and physical activity. Other prespecified outcomes will include change in individual components of the Healthy Eating Index-2015 score, and satisfaction with the Healthy BP research study measured on a 5-point Likert scale.
The study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations.
NCT03700710.
体重减轻、采用 DASH 饮食模式、减少钠的摄入和增加身体活动已被证明可以降低血压（BP）。使用基于网络的工具和远程医疗来提供生活方式咨询可能是通过行为改变来提高血压的潜在可扩展解决方案，尽管在临床实践中支持这些方法的数据有限。
这项随机对照试验将比较远程医疗与自我指导的生活方式干预在降低超重/肥胖（体重指数≥25kg/m 2 ）和 24 小时收缩压 120-160mmHg 患者 24 小时收缩压方面的疗效。所有参与者都根据基于网络的食物频率问卷、访问在线综合体重管理计划和智能手机饮食应用程序获得个性化的改善饮食质量的建议。远程医疗组还包括每周与注册营养师的电话沟通，营养师使用动机访谈。主要结局是从基线到 12 周时 24 小时收缩压的变化。次要结局包括从基线到 24 小时舒张压、白天收缩压、夜间收缩压、白天舒张压、夜间舒张压、健康饮食指数-2015 总分、体重、腰围和体力活动的变化。其他预定的结局将包括健康饮食指数-2015 评分各个组成部分的变化，以及通过 5 点李克特量表衡量的对健康血压研究的满意度。
该研究已获得 Geisinger 机构审查委员会的批准。结果将通过同行评议的出版物和会议演讲传播。
NCT03700710。
