Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health (FINNCARE)
14 декабря 2020 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
400
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Tiina Jääskeläinen, PhD
- Номер телефона: +358 50 4150274
- Электронная почта: tiina.j.jaaskelainen@helsinki.fi
Учебное резервное копирование контактов
- Имя: Taisto Sarkola, PhD, MD
- Номер телефона: +358504274971
- Электронная почта: taisto.sarkola@hus.fi
Места учебы
-
-
-
Helsinki, Финляндия, 00029
- Рекрутинг
- Helsinki University Hospital
-
Контакт:
- Taisto Sarkola, PhD, MD
- Номер телефона: +358504274971
- Электронная почта: taisto.sarkola@hus.fi
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
|
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.
|
|
Без вмешательства: 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.
|
|
|
Без вмешательства: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Blood pressure (mothers)
Временное ограничение: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
|
Blood pressure (children)
Временное ограничение: baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Blood pressure 24 hour variability (mothers)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
|
Adiposity (mothers)
Временное ограничение: baseline -12 months
|
BMI; kg/m2
|
baseline -12 months
|
|
Adiposity (mothers)
Временное ограничение: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
|
Adiposity (mothers)
Временное ограничение: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
|
Dietary intake (mothers)
Временное ограничение: baseline -12 months
|
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
|
baseline -12 months
|
|
Dietary intake (mothers)
Временное ограничение: baseline -12 months
|
food frequency questionnaire on fiber intake; g/day
|
baseline -12 months
|
|
Dietary intake (mothers)
Временное ограничение: baseline -12 months
|
food frequency questionnaire on salt intake; g/d
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
questionnaire data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
Временное ограничение: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
Временное ограничение: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
Временное ограничение: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Smoking (mothers)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (mothers)
Временное ограничение: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (mothers)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
|
Adiposity (children)
Временное ограничение: baseline -12 months
|
BMI z-score
|
baseline -12 months
|
|
Adiposity (children)
Временное ограничение: baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
|
Adiposity (children)
Временное ограничение: baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
|
Dietary intake (children)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: baseline -12 months
|
questionnaire data: structured physical activity outside school hours
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
questionnaire data: unstructured physical activity outside school hours
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
questionnaire data: screen time and non-screen time sitting
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
accelerometer data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
Временное ограничение: baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Временное ограничение: baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Временное ограничение: baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
Временное ограничение: baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
|
baseline -12 months
|
|
Process evaluation: reach
Временное ограничение: baseline
|
participation rate of the families recruited (research database on study visits)
|
baseline
|
|
Process evaluation: reach
Временное ограничение: baseline
|
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
|
baseline
|
|
Process evaluation: compliance
Временное ограничение: baseline -12 months
|
participation rate in measurements (number of study visits and questionnaires completed)
|
baseline -12 months
|
|
Process evaluation: compliance
Временное ограничение: 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
Временное ограничение: baseline -12 months
|
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
|
baseline -12 months
|
|
Process evaluation: acceptability
Временное ограничение: 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
Временное ограничение: baseline -12 months
|
occurrence of technical problems (questionnaire)
|
baseline -12 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Arterial wall thickness (mothers)
Временное ограничение: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (mothers)
Временное ограничение: baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (mothers)
Временное ограничение: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (mothers)
Временное ограничение: baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (mothers)
Временное ограничение: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (mothers)
Временное ограничение: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (mothers)
Временное ограничение: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Arterial wall thickness (children)
Временное ограничение: baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (children)
Временное ограничение: baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (children)
Временное ограничение: baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (children)
Временное ограничение: baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (children)
Временное ограничение: baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (children)
Временное ограничение: baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (children)
Временное ограничение: baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Tiina Jääskeläinen, PhD, University of Helsinki
- Учебный стул: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
- Директор по исследованиям: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июня 2019 г.
Первичное завершение (Ожидаемый)
1 декабря 2022 г.
Завершение исследования (Ожидаемый)
1 декабря 2024 г.
Даты регистрации исследования
Первый отправленный
7 декабря 2020 г.
Впервые представлено, что соответствует критериям контроля качества
14 декабря 2020 г.
Первый опубликованный (Действительный)
21 декабря 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 декабря 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 декабря 2020 г.
Последняя проверка
1 декабря 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FINNCARE
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .