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

NCT ID: NCT04676295

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Pre-Eclampsia; Cardiovascular Diseases; Cardiovascular Risk Factor; Gestational Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PE intervention

A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.

Group Type: EXPERIMENTAL

Face-to-face and web-based lifestyle intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Face-to-face and web-based lifestyle intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Pregnancy and/or lactation (for all mothers)
• Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tiina Jääskeläinen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiina Jääskeläinen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Hannele Laivuori, Prof, MD

Role: STUDY_CHAIR

University of Helsinki and University of Tampere

Taisto Sarkola, PhD, MD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Tiina Jääskeläinen, PhD

Role: CONTACT

Phone: +358 50 4150274

Email: tiina.j.jaaskelainen@helsinki.fi

Taisto Sarkola, PhD, MD

Role: CONTACT

Phone: +358504274971

Email: taisto.sarkola@hus.fi

Facility Contacts

Taisto Sarkola, PhD, MD

Role: primary

References

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.

Reference Type: RESULT

PMID: 28067621 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39011963 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37337860 (View on PubMed)

Other Identifiers

FINNCARE

Identifier Type: -

Identifier Source: org_study_id