Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health (FINNCARE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tiina Jääskeläinen, PhD
- 電話番号：+358 50 4150274
- メール：tiina.j.jaaskelainen@helsinki.fi
研究連絡先のバックアップ
- 名前：Taisto Sarkola, PhD, MD
- 電話番号：+358504274971
- メール：taisto.sarkola@hus.fi
研究場所
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-
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Helsinki、フィンランド、00029
- 募集
- Helsinki University Hospital
-
コンタクト：
- Taisto Sarkola, PhD, MD
- 電話番号：+358504274971
- メール：taisto.sarkola@hus.fi
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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|
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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood pressure (mothers)
時間枠：baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
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Blood pressure (children)
時間枠：baseline -12 months
|
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
|
baseline -12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood pressure 24 hour variability (mothers)
時間枠：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)
時間枠：baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
|
Adiposity (mothers)
時間枠：baseline -12 months
|
BMI; kg/m2
|
baseline -12 months
|
|
Adiposity (mothers)
時間枠：baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
|
Adiposity (mothers)
時間枠：baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
|
Dietary intake (mothers)
時間枠：baseline -12 months
|
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
|
baseline -12 months
|
|
Dietary intake (mothers)
時間枠：baseline -12 months
|
food frequency questionnaire on fiber intake; g/day
|
baseline -12 months
|
|
Dietary intake (mothers)
時間枠：baseline -12 months
|
food frequency questionnaire on salt intake; g/d
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
時間枠：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)
時間枠：baseline -12 months
|
questionnaire data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
時間枠：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)
時間枠：baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
時間枠：baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
時間枠：baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (mothers)
時間枠：baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Smoking (mothers)
時間枠：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)
時間枠：baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (mothers)
時間枠：baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (mothers)
時間枠：baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
|
baseline -12 months
|
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Awareness of later life morbidity (mothers)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：baseline -12 months
|
carotid-femoral pulse wave velocity; m/s
|
baseline -12 months
|
|
Adiposity (children)
時間枠：baseline -12 months
|
BMI z-score
|
baseline -12 months
|
|
Adiposity (children)
時間枠：baseline -12 months
|
waist-hip-ratio (no unit)
|
baseline -12 months
|
|
Adiposity (children)
時間枠：baseline -12 months
|
body fat percentage; %
|
baseline -12 months
|
|
Dietary intake (children)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：baseline -12 months
|
questionnaire data: structured physical activity outside school hours
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
questionnaire data: unstructured physical activity outside school hours
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
questionnaire data: screen time and non-screen time sitting
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
accelerometer data: daily number of steps
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
accelerometer data: daily minutes of total and intensity-specific physical activity
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
accelerometer data: daily minutes of stationary behavior
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
accelerometer data: meeting physical activity recommendations
|
baseline -12 months
|
|
Physical activity and sedentary behavior (children)
時間枠：baseline -12 months
|
accelerometer data: daily number of breaks in stationary behavior
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
時間枠：baseline -12 months
|
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
時間枠：baseline -12 months
|
hs-CRP; mg/l
|
baseline -12 months
|
|
Laboratory assessment of cardiovascular risk (children)
時間枠：baseline -12 months
|
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
|
baseline -12 months
|
|
Process evaluation: reach
時間枠：baseline
|
participation rate of the families recruited (research database on study visits)
|
baseline
|
|
Process evaluation: reach
時間枠：baseline
|
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
|
baseline
|
|
Process evaluation: compliance
時間枠：baseline -12 months
|
participation rate in measurements (number of study visits and questionnaires completed)
|
baseline -12 months
|
|
Process evaluation: compliance
時間枠：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
時間枠：baseline -12 months
|
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
|
baseline -12 months
|
|
Process evaluation: acceptability
時間枠：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
時間枠：baseline -12 months
|
occurrence of technical problems (questionnaire)
|
baseline -12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Arterial wall thickness (mothers)
時間枠：baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (mothers)
時間枠：baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (mothers)
時間枠：baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (mothers)
時間枠：baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (mothers)
時間枠：baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (mothers)
時間枠：baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (mothers)
時間枠：baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Arterial wall thickness (children)
時間枠：baseline
|
intima-media thickness; common carotid, brachial and radial; mm
|
baseline
|
|
Left ventricular mass (children)
時間枠：baseline
|
left ventricular mass; g
|
baseline
|
|
Left ventricular systolic function (children)
時間枠：baseline
|
left ventricular global longitudinal strain; %
|
baseline
|
|
Left ventricular diastolic function (children)
時間枠：baseline
|
left atrial volume; ml
|
baseline
|
|
Left ventricular diastolic function (children)
時間枠：baseline
|
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
|
baseline
|
|
Left ventricular diastolic function (children)
時間枠：baseline
|
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
|
Left ventricular diastolic function (children)
時間枠：baseline
|
septal pulsed wave tissue Doppler early velocity; cm/s
|
baseline
|
協力者と研究者
捜査官
- 主任研究者：Tiina Jääskeläinen, PhD、University of Helsinki
- スタディチェア：Hannele Laivuori, Prof, MD、University of Helsinki and University of Tampere
- スタディディレクター：Taisto Sarkola, PhD, MD、Helsinki University Central Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。