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

14 grudnia 2020 zaktualizowane przez: Tiina Jääskeläinen, Helsinki University Central Hospital

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

400

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Finlandia
      • Helsinki, Finlandia, 00029
        • Rekrutacyjny
        • Helsinki University Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
Behawioralne: 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.
Brak interwencji: 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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Blood pressure (mothers)
Ramy czasowe: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
baseline -12 months
Blood pressure (children)
Ramy czasowe: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
baseline -12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Blood pressure 24 hour variability (mothers)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
carotid-femoral pulse wave velocity; m/s
baseline -12 months
Adiposity (mothers)
Ramy czasowe: baseline -12 months
BMI; kg/m2
baseline -12 months
Adiposity (mothers)
Ramy czasowe: baseline -12 months
waist-hip-ratio (no unit)
baseline -12 months
Adiposity (mothers)
Ramy czasowe: baseline -12 months
body fat percentage; %
baseline -12 months
Dietary intake (mothers)
Ramy czasowe: baseline -12 months
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
baseline -12 months
Dietary intake (mothers)
Ramy czasowe: baseline -12 months
food frequency questionnaire on fiber intake; g/day
baseline -12 months
Dietary intake (mothers)
Ramy czasowe: baseline -12 months
food frequency questionnaire on salt intake; g/d
baseline -12 months
Physical activity and sedentary behavior (mothers)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
questionnaire data: meeting physical activity recommendations
baseline -12 months
Physical activity and sedentary behavior (mothers)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
accelerometer data: daily number of steps
baseline -12 months
Physical activity and sedentary behavior (mothers)
Ramy czasowe: baseline -12 months
accelerometer data: daily minutes of total and intensity-specific physical activity
baseline -12 months
Physical activity and sedentary behavior (mothers)
Ramy czasowe: baseline -12 months
accelerometer data: daily minutes of stationary behavior
baseline -12 months
Physical activity and sedentary behavior (mothers)
Ramy czasowe: baseline -12 months
accelerometer data: daily number of breaks in stationary behavior
baseline -12 months
Smoking (mothers)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
baseline -12 months
Laboratory assessment of cardiovascular risk (mothers)
Ramy czasowe: baseline -12 months
hs-CRP; mg/l
baseline -12 months
Laboratory assessment of cardiovascular risk (mothers)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
carotid-femoral pulse wave velocity; m/s
baseline -12 months
Adiposity (children)
Ramy czasowe: baseline -12 months
BMI z-score
baseline -12 months
Adiposity (children)
Ramy czasowe: baseline -12 months
waist-hip-ratio (no unit)
baseline -12 months
Adiposity (children)
Ramy czasowe: baseline -12 months
body fat percentage; %
baseline -12 months
Dietary intake (children)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: baseline -12 months
questionnaire data: structured physical activity outside school hours
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
questionnaire data: unstructured physical activity outside school hours
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
questionnaire data: screen time and non-screen time sitting
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
accelerometer data: daily number of steps
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
accelerometer data: daily minutes of total and intensity-specific physical activity
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
accelerometer data: daily minutes of stationary behavior
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
accelerometer data: meeting physical activity recommendations
baseline -12 months
Physical activity and sedentary behavior (children)
Ramy czasowe: baseline -12 months
accelerometer data: daily number of breaks in stationary behavior
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Ramy czasowe: baseline -12 months
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Ramy czasowe: baseline -12 months
hs-CRP; mg/l
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Ramy czasowe: baseline -12 months
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
baseline -12 months
Process evaluation: reach
Ramy czasowe: baseline
participation rate of the families recruited (research database on study visits)
baseline
Process evaluation: reach
Ramy czasowe: baseline
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
baseline
Process evaluation: compliance
Ramy czasowe: baseline -12 months
participation rate in measurements (number of study visits and questionnaires completed)
baseline -12 months
Process evaluation: compliance
Ramy czasowe: 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
Ramy czasowe: baseline -12 months
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
baseline -12 months
Process evaluation: acceptability
Ramy czasowe: 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
Ramy czasowe: baseline -12 months
occurrence of technical problems (questionnaire)
baseline -12 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Arterial wall thickness (mothers)
Ramy czasowe: baseline
intima-media thickness; common carotid, brachial and radial; mm
baseline
Left ventricular mass (mothers)
Ramy czasowe: baseline
left ventricular mass; g
baseline
Left ventricular systolic function (mothers)
Ramy czasowe: baseline
left ventricular global longitudinal strain; %
baseline
Left ventricular diastolic function (mothers)
Ramy czasowe: baseline
left atrial volume; ml
baseline
Left ventricular diastolic function (mothers)
Ramy czasowe: baseline
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
baseline
Left ventricular diastolic function (mothers)
Ramy czasowe: baseline
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
baseline
Left ventricular diastolic function (mothers)
Ramy czasowe: baseline
septal pulsed wave tissue Doppler early velocity; cm/s
baseline
Arterial wall thickness (children)
Ramy czasowe: baseline
intima-media thickness; common carotid, brachial and radial; mm
baseline
Left ventricular mass (children)
Ramy czasowe: baseline
left ventricular mass; g
baseline
Left ventricular systolic function (children)
Ramy czasowe: baseline
left ventricular global longitudinal strain; %
baseline
Left ventricular diastolic function (children)
Ramy czasowe: baseline
left atrial volume; ml
baseline
Left ventricular diastolic function (children)
Ramy czasowe: baseline
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
baseline
Left ventricular diastolic function (children)
Ramy czasowe: baseline
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
baseline
Left ventricular diastolic function (children)
Ramy czasowe: baseline
septal pulsed wave tissue Doppler early velocity; cm/s
baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Helsinki University Central Hospital

Współpracownicy

University of Helsinki

Śledczy

  • Główny śledczy: Tiina Jääskeläinen, PhD, University of Helsinki
  • Krzesło do nauki: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
  • Dyrektor Studium: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2019

Zakończenie podstawowe (Oczekiwany)

1 grudnia 2022

Ukończenie studiów (Oczekiwany)

1 grudnia 2024

Daty rejestracji na studia

Pierwszy przesłany

7 grudnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 grudnia 2020

Pierwszy wysłany (Rzeczywisty)

21 grudnia 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 grudnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 grudnia 2020

Ostatnia weryfikacja

1 grudnia 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FINNCARE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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