TY - JOUR
T1 - Protocol
T2 - A randomized controlled trial to assess effectiveness of a 12-month lifestyle intervention to reduce cardiovascular disease risk in families ten years after pre-eclampsia (FINNCARE)
AU - Jääskeläinen, Tiina
AU - Kivelä, Anni
AU - Renlund, Michelle
AU - Heinonen, Seppo
AU - Aittasalo, Minna
AU - Laivuori, Hannele
AU - Sarkola, Taisto
N1 - Funding Information:
Study is supported by Juho Vainio Foundation (TJ), Jane and Aatos Erkko Foundation (HL), Päivikki and Sakari Sohlberg Foundation (HL), Research Funds of the University of Helsinki, Government special subsidy for health sciences (In Finnish; Valtion tutkimusrahoitus) at the Hospital District of Helsinki and Uusimaa (SH), Sigrid Juselius Foundation (TS), The Medical Society of Finland (HL, TS, MR), Medicinska understödsföreningen Liv och Hälsa rf (TS), Finnish Foundation for Pediatric Research (TS), and Dorothea Olivia, Karl Walter och Jarl Walter Perklén foundation (TS, MR) , the Competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital (HL).
Funding Information:
Scientific contribution of Maijaliisa Erkkola, Aki Havulinna, Eero Kajantie and Mikko Tulppo is thanked. FINNPEC and the expert research assistance of Eija Kortelainen, Maria Finne and Heini Hyv?rinen are also gratefully acknowledged.
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/4
Y1 - 2022/4
N2 - Pre-eclampsia (PE) is a multisystem progressive disorder affecting 3–5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term. The effectiveness of a family-centered lifestyle intervention to lower CVD risk in PE families has not previously been evaluated. In the current FINNCARE study, we prospectively compare CVD risk and CVD progression in PE families (mother, father and child) in a cross-sectional study setting 8–12 years from delivery with non-PE control families of comparable age. Furthermore, we evaluate the effectiveness and feasibility of an interactive web-based behavioral 12-month lifestyle intervention to reduce blood pressure and the CVD risk profile overall in a randomized controlled trial. In total, 300 PE families will be randomized 1:1 to a PE-intervention or a PE-control group, and the 100 non-PE control families similarly followed-up at 12 months. Primary outcome is 24-hour mean systolic BP change from baseline in mother and child. Study aims to provide information on CVD progression and CVD risk management in the family following PE.
AB - Pre-eclampsia (PE) is a multisystem progressive disorder affecting 3–5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term. The effectiveness of a family-centered lifestyle intervention to lower CVD risk in PE families has not previously been evaluated. In the current FINNCARE study, we prospectively compare CVD risk and CVD progression in PE families (mother, father and child) in a cross-sectional study setting 8–12 years from delivery with non-PE control families of comparable age. Furthermore, we evaluate the effectiveness and feasibility of an interactive web-based behavioral 12-month lifestyle intervention to reduce blood pressure and the CVD risk profile overall in a randomized controlled trial. In total, 300 PE families will be randomized 1:1 to a PE-intervention or a PE-control group, and the 100 non-PE control families similarly followed-up at 12 months. Primary outcome is 24-hour mean systolic BP change from baseline in mother and child. Study aims to provide information on CVD progression and CVD risk management in the family following PE.
KW - Cardiovascular disease
KW - Family
KW - Lifestyle intervention
KW - Pre-eclampsia
KW - Prevention
U2 - 10.1016/j.pmedr.2022.101731
DO - 10.1016/j.pmedr.2022.101731
M3 - Article
AN - SCOPUS:85124743923
SN - 2211-3355
VL - 26
JO - Preventive Medicine Reports
JF - Preventive Medicine Reports
M1 - 101731
ER -