Taylor Rachael, Shrewsbury Vanessa A, Vincze Lisa, Campbell Linda, Callister Robin, Park Felicity, Schumacher Tracy, Collins Clare, Hutchesson Melinda
School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, The University of Newcastle, Newcastle, NSW, Australia.
School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.
Front Cardiovasc Med. 2019 Sep 26;6:144. doi: 10.3389/fcvm.2019.00144. eCollection 2019.
Women with a history of preeclampsia are at greater risk of cardiovascular disease (CVD) related morbidity. Despite this knowledge, there is a lack of interventions available for women with a history of preeclampsia for the prevention of CVD. The aim of this pilot randomized controlled trial (RCT) is to determine the acceptability and preliminary efficacy of a web-based behavioral intervention targeted to women with a history of preeclampsia (Be Healthe for your Heart). Australian women aged 18-45 years, with a recent history (≤4 years post diagnosis) of preeclampsia will be recruited for a 3-months, 2-arm parallel group pilot RCT. Participants will be randomized into 2 study arms: (1) Be Healthe for your Heart or; (2) Control, with assessments conducted at baseline, and after 3-months. Be Healthe for your Heart is an intervention delivered online via the program website, with weekly emails to support changes in modifiable CVD risk factors (excess body weight, physical inactivity, poor diet, and stress), using behavior change techniques (e.g., self-monitoring, goal setting). Intervention acceptability (satisfaction, usability, appropriateness, and usage) and impact on absolute full CVD 30-years risk score, CVD risk markers, and modifiable risk factors will be assessed. No studies to date have evaluated acceptability and preliminary efficacy of a web-based intervention for the prevention of CVD in this high-risk population with preeclampsia. This pilot trial will inform development of a fully powered RCT if acceptability and preliminary efficacy are demonstrated.
有子痫前期病史的女性患心血管疾病（CVD）相关发病的风险更高。尽管有这一认知，但对于有子痫前期病史的女性，缺乏可用于预防CVD的干预措施。这项初步随机对照试验（RCT）的目的是确定针对有子痫前期病史女性的基于网络的行为干预措施（“为你的心脏保持健康”）的可接受性和初步疗效。将招募年龄在18 - 45岁、近期（诊断后≤4年）有子痫前期病史的澳大利亚女性参加一项为期3个月的双臂平行组初步RCT。参与者将被随机分为两个研究组：（1）“为你的心脏保持健康”组；或（2）对照组，在基线时以及3个月后进行评估。“为你的心脏保持健康”是通过项目网站在线提供的干预措施，每周发送电子邮件以支持可改变的CVD风险因素（超重、缺乏身体活动、不良饮食和压力）的改变，采用行为改变技术（如自我监测、设定目标）。将评估干预措施的可接受性（满意度、可用性、适宜性和使用情况）以及对30年绝对全CVD风险评分、CVD风险标志物和可改变风险因素的影响。迄今为止，尚无研究评估基于网络的干预措施对这一有子痫前期的高危人群预防CVD的可接受性和初步疗效。如果证明了可接受性和初步疗效，这项初步试验将为开展一项充分有力的RCT提供依据。
