Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health (FINNCARE)
14 dicembre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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:
- 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.
- 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.
- To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
400
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Tiina Jääskeläinen, PhD
- Numero di telefono: +358 50 4150274
- Email: tiina.j.jaaskelainen@helsinki.fi
Backup dei contatti dello studio
- Nome: Taisto Sarkola, PhD, MD
- Numero di telefono: +358504274971
- Email: taisto.sarkola@hus.fi
Luoghi di studio
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-
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Helsinki, Finlandia, 00029
- Reclutamento
- Helsinki university hospital
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Contatto:
- Taisto Sarkola, PhD, MD
- Numero di telefono: +358504274971
- Email: taisto.sarkola@hus.fi
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
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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.
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Nessun intervento: 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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Blood pressure (mothers)
Lasso di tempo: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
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baseline -12 months
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Blood pressure (children)
Lasso di tempo: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
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baseline -12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Blood pressure 24 hour variability (mothers)
Lasso di tempo: 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
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baseline -12 months
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Arterial stiffness (mothers)
Lasso di tempo: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
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Adiposity (mothers)
Lasso di tempo: baseline -12 months
|
BMI; kg/m2
|
baseline -12 months
|
|
Adiposity (mothers)
Lasso di tempo: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
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Adiposity (mothers)
Lasso di tempo: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
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Dietary intake (mothers)
Lasso di tempo: baseline -12 months
|
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
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baseline -12 months
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Dietary intake (mothers)
Lasso di tempo: baseline -12 months
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food frequency questionnaire on fiber intake; g/day
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baseline -12 months
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Dietary intake (mothers)
Lasso di tempo: baseline -12 months
|
food frequency questionnaire on salt intake; g/d
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baseline -12 months
|
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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questionnaire data: meeting physical activity recommendations
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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questionnaire data: daily minutes of sitting on a non-weekend and weekend day
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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accelerometer data: daily number of steps
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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accelerometer data: daily minutes of total and intensity-specific physical activity
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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accelerometer data: daily minutes of stationary behavior
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baseline -12 months
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Physical activity and sedentary behavior (mothers)
Lasso di tempo: baseline -12 months
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accelerometer data: daily number of breaks in stationary behavior
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baseline -12 months
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Smoking (mothers)
Lasso di tempo: baseline -12 months
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questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day
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baseline -12 months
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Laboratory assessment of cardiovascular risk (mothers)
Lasso di tempo: baseline -12 months
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lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
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baseline -12 months
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Laboratory assessment of cardiovascular risk (mothers)
Lasso di tempo: baseline -12 months
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hs-CRP; mg/l
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baseline -12 months
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Laboratory assessment of cardiovascular risk (mothers)
Lasso di tempo: baseline -12 months
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HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
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baseline -12 months
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Awareness of later life morbidity (mothers)
Lasso di tempo: baseline -12 months
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A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity
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baseline -12 months
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Heart rate variability (mothers)
Lasso di tempo: baseline -12 months
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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
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baseline -12 months
|
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Blood pressure 24 hour variability (children)
Lasso di tempo: 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
|
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Arterial stiffness (children)
Lasso di tempo: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
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baseline -12 months
|
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Adiposity (children)
Lasso di tempo: baseline -12 months
|
BMI z-score
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baseline -12 months
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Adiposity (children)
Lasso di tempo: baseline -12 months
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waist-hip-ratio (no unit)
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baseline -12 months
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Adiposity (children)
Lasso di tempo: baseline -12 months
|
body fat percentage; %
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baseline -12 months
|
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Dietary intake (children)
Lasso di tempo: baseline -12 months
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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)
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baseline -12 months
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
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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
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baseline -12 months
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
questionnaire data: weekly number of days and daily duration of active travel to school and hobbies
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baseline -12 months
|
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
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questionnaire data: structured physical activity outside school hours
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baseline -12 months
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
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questionnaire data: unstructured physical activity outside school hours
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baseline -12 months
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
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questionnaire data: screen time and non-screen time sitting
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baseline -12 months
|
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Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
accelerometer data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Lasso di tempo: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Lasso di tempo: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Lasso di tempo: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
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Laboratory assessment of cardiovascular risk (children)
Lasso di tempo: baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
|
baseline -12 months
|
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Process evaluation: reach
Lasso di tempo: baseline
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participation rate of the families recruited (research database on study visits)
|
baseline
|
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Process evaluation: reach
Lasso di tempo: baseline
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representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
|
baseline
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Process evaluation: compliance
Lasso di tempo: baseline -12 months
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participation rate in measurements (number of study visits and questionnaires completed)
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baseline -12 months
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Process evaluation: compliance
Lasso di tempo: baseline -12 months
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proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)
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baseline -12 months
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Process evaluation: acceptability
Lasso di tempo: baseline -12 months
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usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
|
baseline -12 months
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Process evaluation: acceptability
Lasso di tempo: baseline -12 months
|
credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)
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baseline -12 months
|
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Process evaluation: acceptability
Lasso di tempo: baseline -12 months
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occurrence of technical problems (questionnaire)
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baseline -12 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Arterial wall thickness (mothers)
Lasso di tempo: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
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Left ventricular mass (mothers)
Lasso di tempo: baseline
|
left ventricular mass; g
|
baseline
|
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Left ventricular systolic function (mothers)
Lasso di tempo: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
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Left ventricular diastolic function (mothers)
Lasso di tempo: baseline
|
left atrial volume; ml
|
baseline
|
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Left ventricular diastolic function (mothers)
Lasso di tempo: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
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Left ventricular diastolic function (mothers)
Lasso di tempo: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
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Left ventricular diastolic function (mothers)
Lasso di tempo: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Arterial wall thickness (children)
Lasso di tempo: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (children)
Lasso di tempo: baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (children)
Lasso di tempo: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (children)
Lasso di tempo: baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (children)
Lasso di tempo: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (children)
Lasso di tempo: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (children)
Lasso di tempo: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Tiina Jääskeläinen, PhD, University of Helsinki
- Cattedra di studio: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
- Direttore dello studio: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2019
Completamento primario (Anticipato)
1 dicembre 2022
Completamento dello studio (Anticipato)
1 dicembre 2024
Date di iscrizione allo studio
Primo inviato
7 dicembre 2020
Primo inviato che soddisfa i criteri di controllo qualità
14 dicembre 2020
Primo Inserito (Effettivo)
21 dicembre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 dicembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 dicembre 2020
Ultimo verificato
1 dicembre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FINNCARE
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .