Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
- Conditions
- Gestational HypertensionCardiovascular Risk FactorPre-EclampsiaCardiovascular Diseases
- Interventions
- Behavioral: Face-to-face and web-based lifestyle intervention
- Registration Number
- NCT04676295
- Lead Sponsor
- Helsinki University Central Hospital
- Brief 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. 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.
- 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:
1. 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.
2. 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.
3. To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PE intervention Face-to-face and web-based lifestyle intervention A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
- Primary Outcome Measures
Name Time Method Blood pressure (mothers) baseline -12 months mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
Blood pressure (children) baseline -12 months mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
- Secondary Outcome Measures
Name Time Method Process evaluation: reach baseline representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
Heart rate variability (mothers) 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
Arterial stiffness (mothers) baseline -12 months carotid-femoral pulse wave velocity; m/s
Adiposity (mothers) baseline -12 months body fat percentage; %
Dietary intake (mothers) baseline -12 months food frequency questionnaire on salt intake; g/d
Physical activity and sedentary behavior (mothers) baseline -12 months accelerometer data: daily number of breaks in stationary behavior
Smoking (mothers) baseline -12 months questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day
Blood pressure 24 hour variability (mothers) 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
Blood pressure 24 hour variability (children) 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
Laboratory assessment of cardiovascular risk (mothers) baseline -12 months HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
Awareness of later life morbidity (mothers) baseline -12 months A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity
Arterial stiffness (children) baseline -12 months carotid-femoral pulse wave velocity; m/s
Adiposity (children) baseline -12 months body fat percentage; %
Dietary intake (children) 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)
Physical activity and sedentary behavior (children) baseline -12 months accelerometer data: daily number of breaks in stationary behavior
Laboratory assessment of cardiovascular risk (children) baseline -12 months HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
Process evaluation: compliance baseline -12 months proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)
Process evaluation: acceptability baseline -12 months occurrence of technical problems (questionnaire)
Trial Locations
- Locations (1)
Helsinki University Hospital
🇫🇮Helsinki, Finland