Pre-EclampsiaFINNCARENCT04676295
Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
A study testing Face-to-face and web-based lifestyle intervention in people with Pre-Eclampsia and Cardiovascular Diseases, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Face-to-face and web-based lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2019to 31 Dec 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy and/or lactation (for all mothers)
- Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pre-Eclampsia, Cardiovascular Diseases, Cardiovascular Risk Factor, Gestational Hypertension
- Being tested
- Face-to-face and web-based lifestyle intervention
- Medical subject headings
- Pre-Eclampsia, Cardiovascular Diseases, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face and web-based lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PE intervention | Experimental | A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile. Receives: Behavioral: Face-to-face and web-based lifestyle intervention |
| PE control | No intervention | 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. |
| Non-PE control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (mothers)
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
Measured: baseline -12 months
Blood pressure (children)
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
Measured: baseline -12 months
Secondary outcomes (45)
Blood pressure 24 hour variability (mothers)
nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg
Measured: baseline -12 months
Arterial stiffness (mothers)
carotid-femoral pulse wave velocity; m/s
Measured: baseline -12 months
Adiposity BMI (mothers)
BMI; kg/m2
Measured: baseline -12 months
Adiposity WHR (mothers)
waist-hip-ratio (no unit)
Measured: baseline -12 months
Adiposity BF% (mothers)
body fat percentage; %
Measured: baseline -12 months
Dietary intake FAT (mothers)
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
Measured: baseline -12 months
Dietary intake FIBER (mothers)
food frequency questionnaire on fiber intake; g/day
Measured: baseline -12 months
Dietary intake SALT (mothers)
food frequency questionnaire on salt intake; g/d
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST1 (mothers)
questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST2 (mothers)
questionnaire data: meeting physical activity recommendations
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST3 (mothers)
questionnaire data: daily minutes of sitting on a non-weekend and weekend day
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY1 (mothers)
accelerometer data: daily number of steps
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY2 (mothers)
accelerometer data: daily minutes of total and intensity-specific physical activity
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY3 (mothers)
accelerometer data: daily minutes of stationary behavior
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY4 (mothers)
accelerometer data: daily number of breaks in stationary behavior
Measured: baseline -12 months
Smoking (mothers)
questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk LIPIDS (mothers)
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk INFL (mothers)
hs-CRP; mg/l
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk HOMA (mothers)
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
Measured: baseline -12 months
Awareness of later life morbidity (mothers)
A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity
Measured: baseline -12 months
Arterial stiffness (children)
carotid-femoral pulse wave velocity; m/s
Measured: baseline -12 months
Adiposity BMI (children)
BMI z-score
Measured: baseline -12 months
Adiposity WHR (children)
waist-hip-ratio (no unit)
Measured: baseline -12 months
Adiposity BF% (children)
body fat percentage; %
Measured: baseline -12 months
Dietary intake FFQ (children)
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)
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST1 (children)
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
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST2 (children)
questionnaire data: weekly number of days and daily duration of active travel to school and hobbies
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST3 (children)
questionnaire data: structured physical activity outside school hours
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST4 (children)
questionnaire data: unstructured physical activity outside school hours
Measured: baseline -12 months
Physical activity and sedentary behavior QUEST5 (children)
questionnaire data: screen time and non-screen time sitting
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY1 (children)
accelerometer data: daily number of steps
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY2 (children)
accelerometer data: daily minutes of total and intensity-specific physical activity
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY3 (children)
accelerometer data: daily minutes of stationary behavior
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY4 (children)
accelerometer data: meeting physical activity recommendations
Measured: baseline -12 months
Physical activity and sedentary behavior ACTIVITY5 (children)
accelerometer data: daily number of breaks in stationary behavior
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk LIPIDS (children)
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk INFL (children)
hs-CRP; mg/l
Measured: baseline -12 months
Laboratory assessment of cardiovascular risk HOMA (children)
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
Measured: baseline -12 months
Process evaluation: reach1
participation rate of the families recruited (research database on study visits)
Measured: baseline
Process evaluation: reach2
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
Measured: baseline
Process evaluation: compliance1
participation rate in measurements (number of study visits and questionnaires completed)
Measured: baseline -12 months
Process evaluation: compliance2
proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)
Measured: baseline -12 months
Process evaluation: acceptability1
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
Measured: baseline -12 months
Process evaluation: acceptability2
credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)
Measured: baseline -12 months
Process evaluation: acceptability3
occurrence of technical problems (questionnaire)
Measured: baseline -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jun 2019
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Tiina Jääskeläinen, University of Helsinki
- Investigators
- Tiina Jääskeläinen, PhD, Principal investigator, University of HelsinkiHannele Laivuori, Prof, MD, Study chair, University of Helsinki and University of TampereTaisto Sarkola, PhD, MD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676295
- Sponsor's protocol ID
- FINNCARE
- Acronym
- FINNCARE
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28067621Renlund 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.
PubMed 37337860Renlund 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.
PubMed 37859683Renlund 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.
PubMed 37921662Renlund-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.
PubMed 39011963Kivela 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.
PubMed 40494156Jaaskelainen 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.
PubMed 42386924