- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676295
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tiina Jääskeläinen, PhD
- Phone Number: +358 50 4150274
- Email: tiina.j.jaaskelainen@helsinki.fi
Study Contact Backup
- Name: Taisto Sarkola, PhD, MD
- Phone Number: +358504274971
- Email: taisto.sarkola@hus.fi
Study Locations
-
-
-
Helsinki, Finland, 00029
- Recruiting
- Helsinki University Hospital
-
Contact:
- Taisto Sarkola, PhD, MD
- Phone Number: +358504274971
- Email: taisto.sarkola@hus.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
No Intervention: 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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure (mothers)
Time Frame: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
Blood pressure (children)
Time Frame: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure 24 hour variability (mothers)
Time Frame: 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)
Time Frame: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
Adiposity (mothers)
Time Frame: baseline -12 months
|
BMI; kg/m2
|
baseline -12 months
|
Adiposity (mothers)
Time Frame: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
Adiposity (mothers)
Time Frame: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
Dietary intake (mothers)
Time Frame: baseline -12 months
|
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
|
baseline -12 months
|
Dietary intake (mothers)
Time Frame: baseline -12 months
|
food frequency questionnaire on fiber intake; g/day
|
baseline -12 months
|
Dietary intake (mothers)
Time Frame: baseline -12 months
|
food frequency questionnaire on salt intake; g/d
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: 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 (mothers)
Time Frame: baseline -12 months
|
questionnaire data: meeting physical activity recommendations
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: baseline -12 months
|
questionnaire data: daily minutes of sitting on a non-weekend and weekend day
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
Physical activity and sedentary behavior (mothers)
Time Frame: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
Smoking (mothers)
Time Frame: 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 (mothers)
Time Frame: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
Laboratory assessment of cardiovascular risk (mothers)
Time Frame: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
Laboratory assessment of cardiovascular risk (mothers)
Time Frame: 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)
Time Frame: baseline -12 months
|
A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity
|
baseline -12 months
|
Heart rate variability (mothers)
Time Frame: 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)
Time Frame: 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 (children)
Time Frame: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
Adiposity (children)
Time Frame: baseline -12 months
|
BMI z-score
|
baseline -12 months
|
Adiposity (children)
Time Frame: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
Adiposity (children)
Time Frame: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
Dietary intake (children)
Time Frame: 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 (children)
Time Frame: 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 (children)
Time Frame: 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 (children)
Time Frame: baseline -12 months
|
questionnaire data: structured physical activity outside school hours
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
questionnaire data: unstructured physical activity outside school hours
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
questionnaire data: screen time and non-screen time sitting
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
accelerometer data: meeting physical activity recommendations
|
baseline -12 months
|
Physical activity and sedentary behavior (children)
Time Frame: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
Laboratory assessment of cardiovascular risk (children)
Time Frame: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
Laboratory assessment of cardiovascular risk (children)
Time Frame: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
Laboratory assessment of cardiovascular risk (children)
Time Frame: baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
|
baseline -12 months
|
Process evaluation: reach
Time Frame: baseline
|
participation rate of the families recruited (research database on study visits)
|
baseline
|
Process evaluation: reach
Time Frame: baseline
|
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
|
baseline
|
Process evaluation: compliance
Time Frame: baseline -12 months
|
participation rate in measurements (number of study visits and questionnaires completed)
|
baseline -12 months
|
Process evaluation: compliance
Time Frame: baseline -12 months
|
proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)
|
baseline -12 months
|
Process evaluation: acceptability
Time Frame: baseline -12 months
|
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
|
baseline -12 months
|
Process evaluation: acceptability
Time Frame: 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: acceptability
Time Frame: baseline -12 months
|
occurrence of technical problems (questionnaire)
|
baseline -12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial wall thickness (mothers)
Time Frame: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
Left ventricular mass (mothers)
Time Frame: baseline
|
left ventricular mass; g
|
baseline
|
Left ventricular systolic function (mothers)
Time Frame: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
Left ventricular diastolic function (mothers)
Time Frame: baseline
|
left atrial volume; ml
|
baseline
|
Left ventricular diastolic function (mothers)
Time Frame: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
Left ventricular diastolic function (mothers)
Time Frame: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Left ventricular diastolic function (mothers)
Time Frame: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Arterial wall thickness (children)
Time Frame: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
Left ventricular mass (children)
Time Frame: baseline
|
left ventricular mass; g
|
baseline
|
Left ventricular systolic function (children)
Time Frame: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
Left ventricular diastolic function (children)
Time Frame: baseline
|
left atrial volume; ml
|
baseline
|
Left ventricular diastolic function (children)
Time Frame: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
Left ventricular diastolic function (children)
Time Frame: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Left ventricular diastolic function (children)
Time Frame: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tiina Jääskeläinen, PhD, University of Helsinki
- Study Chair: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
- Study Director: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FINNCARE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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