Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health (FINNCARE)
Background: PE (pre-eclampsia) is a common pregnancy-specific vascular hypertensive disease affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their offspring long-term. PE provides a unique window for early risk profiling and CVD prevention. However, the efficacy of a family oriented lifestyle intervention to lower CVD risk in families with history of PE has not previously been evaluated.
Aim: This study will explore the impact of PE on CVD progression 8-12 years from delivery in mothers and their children, and assess whether a lifestyle intervention is useful for lowering mother and child blood pressure and improving the CVD risk profile overall in families with a history of PE.
Hypothesis: PE is related with CVD progression mediated by elevated blood pressure. Blood pressure and the CVD risk profile overall is modifiable in mothers and children by a 12-month behavioral lifestyle intervention in families with a history of PE.
Study design: Randomized controlled behavioral lifestyle intervention trial where families (mother, child and father from the FINNPEC study) are offered the opportunity to participate in a lifestyle intervention program 8-12 years after a PE pregnancy. 300 PE families will be randomized 1:1 to a 12-month lifestyle intervention program or to a control group. A parallel group of 100 non-PE control families will be assessed at baseline and follow-up.
Main outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child.
Significance: This study will provide information on CVD progression in mothers and children 8-12 years from a PE pregnancy. Furthermore, the study assess the effect of a 12-month lifestyle intervention on blood pressure and CVD risk profile overall following a PE pregnancy. Potentially, the study provides the opportunity to identify PE families at highest risk of CVD progression and families amenable to blood pressure and CVD risk profile improvement.
研究概览
详细说明
Power analysis:
Power calculations were performed in order to detect 5.5 mmHg reduction in maternal systolic blood pressure with a power of 80% and a 2-sided p-value of 0.05 for the difference between the groups (intervention and control PE) (NICE 2011). Accounting for a 20% loss to follow-up or missing data, a sample of 148 women in the PE intervention group and 148 women in the PE control group is needed.
Specific objectives:
- To assess cardiovascular health and CVD progression in families (mother, child and father) 8-12 years following a PE pregnancy compared with non-PE control families.
- To assess the effectiveness of a behavioral 12-month lifestyle intervention in mothers and their children 8-12 years following a PE pregnancy to lower blood pressure and improve their CVD risk profile overall.
- To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Helsinki、芬兰、00029
- Helsinki University Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Families are recruited from the FINNPEC cohort. In FINNPEC, PE was defined as hypertension and proteinuria occurring after 20 weeks gestation (American College of Obstetricians and Gynecologists 2002 criteria). Hypertension was defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg. Proteinuria was defined as urinary excretion of ≥0.3 g protein in a 24-hour specimen, or 0.3 g/L, or two ≥1+ readings on a dipstick in a random urine determination with no evidence of a urinary tract infection. Each PE diagnosis was ascertained based on hospital records and confirmed independently by a research nurse and a study physician in the original FINNPEC case-control study including 1450 nulliparous or multiparous women with a singleton pregnancy with PE and 1065 pregnant control women without PE (aged 18-47 years) from all 5 university hospitals in Finland during 2008-2011.
Exclusion criteria in the FINNPEC: multiple pregnancy, inability to speak Finnish or Swedish.
Exclusion Criteria in the FINNCARE:
- Pregnancy and/or lactation (for all mothers)
- Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile. |
Families are provided at baseline with one 60 min face-to-face dietary counseling session with nutritionist using family-oriented motivational interviewing and solution focusing techniques. The intervention continues in an interactive web-based portal where different modules include assignments, activities, and tests and related videos targeting five cardiovascular health-linked behaviors: 1) improving quality of fat in the diet, 2) increasing the consumption of foods rich in fiber, 3) decreasing the use of salt, 4) increasing physical activity and 5) reducing smoking. |
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无干预：PE control
The control group continue habitual lifestyle but will perform the same baseline and follow-up measurements as the intervention group. They will be given general written information on healthy eating. |
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无干预：Non-PE control
The control group continue habitual lifestyle but will perform the same baseline and follow-up measurements as the intervention group. They will be given general written information on healthy eating. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure (mothers)
大体时间：baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg |
baseline -12 months
|
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Blood pressure (children)
大体时间：baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg |
baseline -12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure 24 hour variability (mothers)
大体时间：baseline -12 months
|
nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg |
baseline -12 months
|
|
Arterial stiffness (mothers)
大体时间：baseline -12 months
|
carotid-femoral pulse wave velocity; m/s |
baseline -12 months
|
|
Adiposity BMI (mothers)
大体时间：baseline -12 months
|
BMI; kg/m2 |
baseline -12 months
|
|
Adiposity WHR (mothers)
大体时间：baseline -12 months
|
waist-hip-ratio (no unit) |
baseline -12 months
|
|
Adiposity BF% (mothers)
大体时间：baseline -12 months
|
body fat percentage; % |
baseline -12 months
|
|
Dietary intake FAT (mothers)
大体时间：baseline -12 months
|
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day) |
baseline -12 months
|
|
Dietary intake FIBER (mothers)
大体时间：baseline -12 months
|
food frequency questionnaire on fiber intake; g/day |
baseline -12 months
|
|
Dietary intake SALT (mothers)
大体时间：baseline -12 months
|
food frequency questionnaire on salt intake; g/d |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST1 (mothers)
大体时间：baseline -12 months
|
questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST2 (mothers)
大体时间：baseline -12 months
|
questionnaire data: meeting physical activity recommendations |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST3 (mothers)
大体时间：baseline -12 months
|
questionnaire data: daily minutes of sitting on a non-weekend and weekend day |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY1 (mothers)
大体时间：baseline -12 months
|
accelerometer data: daily number of steps |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY2 (mothers)
大体时间：baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY3 (mothers)
大体时间：baseline -12 months
|
accelerometer data: daily minutes of stationary behavior |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY4 (mothers)
大体时间：baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior |
baseline -12 months
|
|
Smoking (mothers)
大体时间：baseline -12 months
|
questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk LIPIDS (mothers)
大体时间：baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l) |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk INFL (mothers)
大体时间：baseline -12 months
|
hs-CRP; mg/l |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk HOMA (mothers)
大体时间：baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5 |
baseline -12 months
|
|
Awareness of later life morbidity (mothers)
大体时间：baseline -12 months
|
A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity |
baseline -12 months
|
|
Arterial stiffness (children)
大体时间：baseline -12 months
|
carotid-femoral pulse wave velocity; m/s |
baseline -12 months
|
|
Adiposity BMI (children)
大体时间：baseline -12 months
|
BMI z-score |
baseline -12 months
|
|
Adiposity WHR (children)
大体时间：baseline -12 months
|
waist-hip-ratio (no unit) |
baseline -12 months
|
|
Adiposity BF% (children)
大体时间：baseline -12 months
|
body fat percentage; % |
baseline -12 months
|
|
Dietary intake FFQ (children)
大体时间：baseline -12 months
|
food frequency questionnaire derived data on SFA index, fiber index, salt index (sum of food items rich in SFA/fiber/salt used during the previous week) |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST1 (children)
大体时间：baseline -12 months
|
questionnaire data: weekly number of days and daily duration of active travel to school and hobbies, structured physical activity outside school hours, unstructured physical activity outside school hours, screen time sitting, non-screen time sitting Accelerometer data: daily number of steps; daily minutes of total and intensity-specific physical activity; daily minutes of and stationary behavior; meeting physical activity recommendations; daily number of breaks in stationary behavior |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST2 (children)
大体时间：baseline -12 months
|
questionnaire data: weekly number of days and daily duration of active travel to school and hobbies |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST3 (children)
大体时间：baseline -12 months
|
questionnaire data: structured physical activity outside school hours |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST4 (children)
大体时间：baseline -12 months
|
questionnaire data: unstructured physical activity outside school hours |
baseline -12 months
|
|
Physical activity and sedentary behavior QUEST5 (children)
大体时间：baseline -12 months
|
questionnaire data: screen time and non-screen time sitting |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY1 (children)
大体时间：baseline -12 months
|
accelerometer data: daily number of steps |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY2 (children)
大体时间：baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY3 (children)
大体时间：baseline -12 months
|
accelerometer data: daily minutes of stationary behavior |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY4 (children)
大体时间：baseline -12 months
|
accelerometer data: meeting physical activity recommendations |
baseline -12 months
|
|
Physical activity and sedentary behavior ACTIVITY5 (children)
大体时间：baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk LIPIDS (children)
大体时间：baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l) |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk INFL (children)
大体时间：baseline -12 months
|
hs-CRP; mg/l |
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk HOMA (children)
大体时间：baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5 |
baseline -12 months
|
|
Process evaluation: reach1
大体时间：baseline
|
participation rate of the families recruited (research database on study visits) |
baseline
|
|
Process evaluation: reach2
大体时间：baseline
|
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics) |
baseline
|
|
Process evaluation: compliance1
大体时间：baseline -12 months
|
participation rate in measurements (number of study visits and questionnaires completed) |
baseline -12 months
|
|
Process evaluation: compliance2
大体时间：baseline -12 months
|
proportion of sessions completed in the web-based portal (data accumulated in the web-based portal) |
baseline -12 months
|
|
Process evaluation: acceptability1
大体时间：baseline -12 months
|
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families) |
baseline -12 months
|
|
Process evaluation: acceptability2
大体时间：baseline -12 months
|
credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families) |
baseline -12 months
|
|
Process evaluation: acceptability3
大体时间：baseline -12 months
|
occurrence of technical problems (questionnaire) |
baseline -12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Arterial wall thickness (mothers)
大体时间：baseline
|
intima-media thickness; common carotid, brachial and radial; mm |
baseline
|
|
Left ventricular mass (mothers)
大体时间：baseline
|
left ventricular mass; g |
baseline
|
|
Left ventricular systolic function (mothers)
大体时间：baseline
|
left ventricular global longitudinal strain; % |
baseline
|
|
Left ventricular diastolic function LAV (mothers)
大体时间：baseline
|
left atrial volume; ml |
baseline
|
|
Left ventricular diastolic function MVPWD (mothers)
大体时间：baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit) |
baseline
|
|
Left ventricular diastolic function MVlatE (mothers)
大体时间：baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s |
baseline
|
|
Left ventricular diastolic function MVseptE (mothers)
大体时间：baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s |
baseline
|
|
Arterial wall thickness (children)
大体时间：baseline
|
intima-media thickness; common carotid, brachial and radial; mm |
baseline
|
|
Left ventricular mass (children)
大体时间：baseline
|
left ventricular mass; g |
baseline
|
|
Left ventricular systolic function (children)
大体时间：baseline
|
left ventricular global longitudinal strain; % |
baseline
|
|
Left ventricular diastolic function LAV (children)
大体时间：baseline
|
left atrial volume; ml |
baseline
|
|
Left ventricular diastolic function MVPWD (children)
大体时间：baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit) |
baseline
|
|
Left ventricular diastolic function MVlatE (children)
大体时间：baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s |
baseline
|
|
Left ventricular diastolic function MVseptE (children)
大体时间：baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s |
baseline
|
|
Heart rate variability (mothers)
大体时间：baseline -12 months
|
standard deviation of all R-R intervals; root mean square of successive R-R interval differences, ms; High frequency power of R-R intervals from spectral band 0.15-0.4 Hz, ms2 ;Low frequency power of R-R intervals from spectral band 0.04-0.15 Hz, ms2 ; and LF/HF ratio |
baseline -12 months
|
|
Blood pressure 24 hour variability (children)
大体时间：baseline -12 months
|
nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg |
baseline -12 months
|
|
HRV RR RMS (mothers)
大体时间：baseline - 12 months
|
root mean square of successive R-R interval differences, ms |
baseline - 12 months
|
|
HRV RR HFP (mothers)
大体时间：baseline - 12 months
|
High frequency power of R-R intervals from spectral band 0.15-0.4 Hz, ms2 |
baseline - 12 months
|
|
HRV RR LFP (mothers)
大体时间：baseline - 12 months
|
Low frequency power of R-R intervals from spectral band 0.04-0.15 Hz, ms2 |
baseline - 12 months
|
|
HRV LF/HF ratio (mothers)
大体时间：baseline - 12 months
|
LF/HF ratio |
baseline - 12 months
|
|
HRV RR RMS (children)
大体时间：baseline - 12 months
|
root mean square of successive R-R interval differences, ms |
baseline - 12 months
|
|
HRV RR HFP (children)
大体时间：baseline - 12 months
|
High frequency power of R-R intervals from spectral band 0.15-0.4 Hz, ms2 |
baseline - 12 months
|
|
HRV RR LFP (children)
大体时间：baseline - 12 months
|
Low frequency power of R-R intervals from spectral band 0.04-0.15 Hz, ms2 |
baseline - 12 months
|
|
HRV LF/HF ratio (children)
大体时间：baseline - 12 months
|
LF/HF ratio |
baseline - 12 months
|
合作者和调查者
调查人员
- 首席研究员：Tiina Jääskeläinen, PhD、University of Helsinki
- 学习椅：Hannele Laivuori, Prof, MD、University of Helsinki and University of Tampere
- 研究主任：Taisto Sarkola, PhD, MD、Helsinki University Central Hospital
出版物和有用的链接
一般刊物
- Jaaskelainen T, Heinonen S, Kajantie E, Kere J, Kivinen K, Pouta A, Laivuori H; FINNPEC Study Group. Cohort profile: the Finnish Genetics of Pre-eclampsia Consortium (FINNPEC). BMJ Open. 2016 Nov 10;6(11):e013148. doi: 10.1136/bmjopen-2016-013148.
- Renlund MA, Jaaskelainen TJ, Kivela ASE, Heinonen ST, Laivuori HM, Sarkola TA. Blood pressure, arterial stiffness, and cardiovascular risk profiles in 8-12-year-old children following preeclampsia (FINNCARE-study). J Hypertens. 2023 Sep 1;41(9):1429-1437. doi: 10.1097/HJH.0000000000003485. Epub 2023 Jun 19.
- Renlund M, Jaaskelainen T, Kivela A, Heinonen S, Laivuori H, Sarkola T. Determinants of vascular structure and function in at-risk children born to mothers managed for pre-eclampsia (FINNCARE study). Front Cardiovasc Med. 2023 Oct 4;10:1264921. doi: 10.3389/fcvm.2023.1264921. eCollection 2023.
- Renlund M, Tulppo MP, Kivela A, Laivuori H, Heinonen S, Jaaskelainen T, Sarkola T. Preeclampsia-exposed children's heart rate variability 8-12 yr after index pregnancy: FINNCARE study. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H74-H81. doi: 10.1152/ajpheart.00540.2023. Epub 2023 Nov 3.
- Renlund-Vikstrom M, Jaaskelainen TJ, Kivela A, Heinonen S, Laivuori H, Sarkola T. Cardiac Structure and Function in 8- to 12-Year-Old Children Following In-Utero Exposure to Preeclampsia (FINNCARE Study). J Am Heart Assoc. 2024 Aug 6;13(15):e034494. doi: 10.1161/JAHA.124.034494. Epub 2024 Jul 16.
- Kivela A, Renlund-Vikstrom M, Heinonen S, Sarkola T, Laivuori H, Jaaskelainen T. Cardiometabolic health 8-12 years after pre-eclampsia: Role of obesity and gestational diabetes (FINNCARE study). Pregnancy Hypertens. 2025 Sep;41:101226. doi: 10.1016/j.preghy.2025.101226. Epub 2025 Jun 9.
- Jaaskelainen T, Lihtamo A, Meuronen T, Turunen S, Karkkainen O, Kivela A, Renlund-Vikstrom M, Sarkola T, Laivuori H, Heinonen S. Long-term alterations in serum metabolite profiles in women with a history of preeclampsia -FINNCARE study. Sci Rep. 2026 Jul 2. doi: 10.1038/s41598-026-59267-3. Online ahead of print.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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