Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health (FINNCARE)
14 de diciembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Anticipado)
400
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tiina Jääskeläinen, PhD
- Número de teléfono: +358 50 4150274
- Correo electrónico: tiina.j.jaaskelainen@helsinki.fi
Copia de seguridad de contactos de estudio
- Nombre: Taisto Sarkola, PhD, MD
- Número de teléfono: +358504274971
- Correo electrónico: taisto.sarkola@hus.fi
Ubicaciones de estudio
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Helsinki, Finlandia, 00029
- Reclutamiento
- Helsinki University Hospital
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Contacto:
- Taisto Sarkola, PhD, MD
- Número de teléfono: +358504274971
- Correo electrónico: taisto.sarkola@hus.fi
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood pressure (mothers)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
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mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure 24 hour variability (mothers)
Periodo de tiempo: 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 (mothers)
Periodo de tiempo: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
|
Adiposity (mothers)
Periodo de tiempo: baseline -12 months
|
BMI; kg/m2
|
baseline -12 months
|
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Adiposity (mothers)
Periodo de tiempo: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
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Adiposity (mothers)
Periodo de tiempo: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
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Dietary intake (mothers)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
|
food frequency questionnaire on salt intake; g/d
|
baseline -12 months
|
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Physical activity and sedentary behavior (mothers)
Periodo de tiempo: baseline -12 months
|
questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking
|
baseline -12 months
|
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Physical activity and sedentary behavior (mothers)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
|
hs-CRP; mg/l
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baseline -12 months
|
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Laboratory assessment of cardiovascular risk (mothers)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
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Adiposity (children)
Periodo de tiempo: baseline -12 months
|
BMI z-score
|
baseline -12 months
|
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Adiposity (children)
Periodo de tiempo: baseline -12 months
|
waist-hip-ratio (no unit)
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baseline -12 months
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Adiposity (children)
Periodo de tiempo: baseline -12 months
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body fat percentage; %
|
baseline -12 months
|
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Dietary intake (children)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
|
questionnaire data: weekly number of days and daily duration of active travel to school and hobbies
|
baseline -12 months
|
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Physical activity and sedentary behavior (children)
Periodo de tiempo: baseline -12 months
|
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)
Periodo de tiempo: 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)
Periodo de tiempo: baseline -12 months
|
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)
Periodo de tiempo: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Periodo de tiempo: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Periodo de tiempo: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Periodo de tiempo: baseline -12 months
|
accelerometer data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Periodo de tiempo: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Periodo de tiempo: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Periodo de tiempo: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Periodo de tiempo: 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
Periodo de tiempo: baseline
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participation rate of the families recruited (research database on study visits)
|
baseline
|
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Process evaluation: reach
Periodo de tiempo: 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
Periodo de tiempo: baseline -12 months
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participation rate in measurements (number of study visits and questionnaires completed)
|
baseline -12 months
|
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Process evaluation: compliance
Periodo de tiempo: baseline -12 months
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proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)
|
baseline -12 months
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Process evaluation: acceptability
Periodo de tiempo: 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
Periodo de tiempo: baseline -12 months
|
credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)
|
baseline -12 months
|
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Process evaluation: acceptability
Periodo de tiempo: baseline -12 months
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occurrence of technical problems (questionnaire)
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baseline -12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Arterial wall thickness (mothers)
Periodo de tiempo: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
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Left ventricular mass (mothers)
Periodo de tiempo: baseline
|
left ventricular mass; g
|
baseline
|
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Left ventricular systolic function (mothers)
Periodo de tiempo: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
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Left ventricular diastolic function (mothers)
Periodo de tiempo: baseline
|
left atrial volume; ml
|
baseline
|
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Left ventricular diastolic function (mothers)
Periodo de tiempo: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
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Left ventricular diastolic function (mothers)
Periodo de tiempo: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
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Left ventricular diastolic function (mothers)
Periodo de tiempo: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
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Arterial wall thickness (children)
Periodo de tiempo: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (children)
Periodo de tiempo: baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (children)
Periodo de tiempo: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (children)
Periodo de tiempo: baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (children)
Periodo de tiempo: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (children)
Periodo de tiempo: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (children)
Periodo de tiempo: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tiina Jääskeläinen, PhD, University of Helsinki
- Silla de estudio: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
- Director de estudio: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2019
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
7 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
14 de diciembre de 2020
Publicado por primera vez (Actual)
21 de diciembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de diciembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
14 de diciembre de 2020
Última verificación
1 de diciembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FINNCARE
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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