AUTHOR=Taylor Rachael , Shrewsbury Vanessa A. , Vincze Lisa , Campbell Linda , Callister Robin , Park Felicity , Schumacher Tracy , Collins Clare , Hutchesson Melinda
TITLE=Be Healthe for Your Heart: Protocol for a Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women With a History of Preeclampsia
JOURNAL=Frontiers in Cardiovascular Medicine
VOLUME=6
YEAR=2019
URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2019.00144
DOI=10.3389/fcvm.2019.00144
ISSN=2297-055X
ABSTRACT=Background: 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).
Method: 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.
Discussion: 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.