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

NCT04676295 | Unknown

• 1 other identifier: FINNCARE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Blood pressure (mothers)

  mean 24 hour ambulatory systolic BP and diastolic BP; mmHg

  baseline -12 months

• Blood pressure (children)

  mean 24 hour ambulatory systolic BP and diastolic BP; mmHg

  baseline -12 months

Secondary Outcomes (47)

• Blood pressure 24 hour variability (mothers)

  baseline -12 months

• Arterial stiffness (mothers)

  baseline -12 months

• Adiposity (mothers)

  baseline -12 months

• Adiposity (mothers)

  baseline -12 months

• Adiposity (mothers)

  baseline -12 months

Other Outcomes (14)

• Arterial wall thickness (mothers)

  baseline

• Left ventricular mass (mothers)

  baseline

• Left ventricular systolic function (mothers)

  baseline

Study Arms (3)

PE intervention

EXPERIMENTAL

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

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.

Interventions

Face-to-face and web-based lifestyle intervention 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 intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

Related Publications (3)

• 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.

  PMID: 28067621 RESULT

• 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.

  PMID: 39011963 DERIVED

• 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.

  PMID: 37337860 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Cardiovascular Diseases; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases

Study Officials

• Tiina Jääskeläinen, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Hannele Laivuori, Prof, MD

  University of Helsinki and University of Tampere

  STUDY CHAIR

• Taisto Sarkola, PhD, MD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Tiina Jääskeläinen, PhD

CONTACT

+358 50 4150274; tiina.j.jaaskelainen@helsinki.fi

Taisto Sarkola, PhD, MD

CONTACT

+358504274971; taisto.sarkola@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 21, 2020
• Study Start: June 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

FI (1)