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

Rachael Taylor; Vanessa A Shrewsbury; Lisa Vincze; Linda Campbell; Robin Callister; Felicity Park; Tracy Schumacher; Clare Collins; Melinda Hutchesson

doi:10.3389/fcvm.2019.00144

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

Front Cardiovasc Med. 2019 Sep 26:6:144. doi: 10.3389/fcvm.2019.00144. eCollection 2019.

Authors

Rachael Taylor¹, Vanessa A Shrewsbury¹, Lisa Vincze², Linda Campbell³, Robin Callister⁴, Felicity Park⁵, Tracy Schumacher⁶, Clare Collins¹, Melinda Hutchesson¹

Affiliations

¹ School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, The University of Newcastle, Newcastle, NSW, Australia.
² School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.
³ School of Psychology, Faculty of Science, The University of Newcastle, Newcastle, NSW, Australia.
⁴ School of Biomedical Sciences and Pharmacy, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, The University of Newcastle, Newcastle, NSW, Australia.
⁵ Department of Maternal Fetal Medicine, John Hunter Hospital, Newcastle, NSW, Australia.
⁶ Department of Rural Health, Faculty of Health and Medicine, University of Newcastle, Tamworth, NSW, Australia.

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.

Keywords: cardiovascular disease; health behavior; post-partum; preeclampsia; prevention; women.