Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health

Helsinki University Central Hospital400 enrolled

Overview

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.

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.

Interventions

Face-to-face and web-based lifestyle interventionBEHAVIORAL

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Blood pressure (mothers)

mean 24 hour ambulatory systolic BP and diastolic BP; mmHg

Time frame: baseline -12 months

Blood pressure (children)

mean 24 hour ambulatory systolic BP and diastolic BP; mmHg

Time frame: baseline -12 months

Secondary Outcomes

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

Time frame: baseline -12 months

Arterial stiffness (mothers)

carotid-femoral pulse wave velocity; m/s

Time frame: baseline -12 months

Adiposity (mothers)

BMI; kg/m2

Time frame: baseline -12 months

Adiposity (mothers)

waist-hip-ratio (no unit)

Time frame: baseline -12 months

Adiposity (mothers)

body fat percentage; %

Time frame: baseline -12 months

Dietary intake (mothers)

food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)

Time frame: baseline -12 months

Dietary intake (mothers)

food frequency questionnaire on fiber intake; g/day

Time frame: baseline -12 months

Dietary intake (mothers)

food frequency questionnaire on salt intake; g/d

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

questionnaire data: meeting physical activity recommendations

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

questionnaire data: daily minutes of sitting on a non-weekend and weekend day

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

accelerometer data: daily number of steps

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

accelerometer data: daily minutes of total and intensity-specific physical activity

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

accelerometer data: daily minutes of stationary behavior

Time frame: baseline -12 months

Physical activity and sedentary behavior (mothers)

accelerometer data: daily number of breaks in stationary behavior

Time frame: 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

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (mothers)

lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (mothers)

hs-CRP; mg/l

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (mothers)

HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5

Time frame: baseline -12 months

Awareness of later life morbidity (mothers)

A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity

Time frame: baseline -12 months

Heart rate variability (mothers)

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

Time frame: baseline -12 months

Blood pressure 24 hour variability (children)

nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg

Time frame: baseline -12 months

Arterial stiffness (children)

carotid-femoral pulse wave velocity; m/s

Time frame: baseline -12 months

Adiposity (children)

BMI z-score

Time frame: baseline -12 months

Adiposity (children)

waist-hip-ratio (no unit)

Time frame: baseline -12 months

Adiposity (children)

body fat percentage; %

Time frame: baseline -12 months

Dietary intake (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)

Time frame: baseline -12 months

Physical activity and sedentary behavior (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

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

questionnaire data: weekly number of days and daily duration of active travel to school and hobbies

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

questionnaire data: structured physical activity outside school hours

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

questionnaire data: unstructured physical activity outside school hours

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

questionnaire data: screen time and non-screen time sitting

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

accelerometer data: daily number of steps

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

accelerometer data: daily minutes of total and intensity-specific physical activity

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

accelerometer data: daily minutes of stationary behavior

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

accelerometer data: meeting physical activity recommendations

Time frame: baseline -12 months

Physical activity and sedentary behavior (children)

accelerometer data: daily number of breaks in stationary behavior

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (children)

lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (children)

hs-CRP; mg/l

Time frame: baseline -12 months

Laboratory assessment of cardiovascular risk (children)

HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5

Time frame: baseline -12 months

Process evaluation: reach

participation rate of the families recruited (research database on study visits)

Time frame: baseline

Process evaluation: reach

representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)

Time frame: baseline

Process evaluation: compliance

participation rate in measurements (number of study visits and questionnaires completed)

Time frame: baseline -12 months

Process evaluation: compliance

proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)

Time frame: baseline -12 months

Process evaluation: acceptability

usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)

Time frame: baseline -12 months

Process evaluation: acceptability

credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)

Time frame: baseline -12 months

Process evaluation: acceptability

occurrence of technical problems (questionnaire)

Time frame: baseline -12 months

Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts