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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676295
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Tiina Jääskeläinen, University of Helsinki

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Cardiovascular Diseases Cardiovascular Risk Factor Gestational Hypertension Behavioral: Face-to-face and web-based lifestyle intervention Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Experimental: PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
Behavioral: 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.

No Intervention: 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.
No Intervention: 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.



Primary Outcome Measures :
  1. Blood pressure (mothers) [ Time Frame: baseline -12 months ]
    mean 24 hour ambulatory systolic BP and diastolic BP; mmHg

  2. Blood pressure (children) [ Time Frame: baseline -12 months ]
    mean 24 hour ambulatory systolic BP and diastolic BP; mmHg


Secondary Outcome Measures :
  1. Blood pressure 24 hour variability (mothers) [ Time Frame: 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

  2. Arterial stiffness (mothers) [ Time Frame: baseline -12 months ]
    carotid-femoral pulse wave velocity; m/s

  3. Adiposity (mothers) [ Time Frame: baseline -12 months ]
    BMI; kg/m2

  4. Adiposity (mothers) [ Time Frame: baseline -12 months ]
    waist-hip-ratio (no unit)

  5. Adiposity (mothers) [ Time Frame: baseline -12 months ]
    body fat percentage; %

  6. Dietary intake (mothers) [ Time Frame: baseline -12 months ]
    food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)

  7. Dietary intake (mothers) [ Time Frame: baseline -12 months ]
    food frequency questionnaire on fiber intake; g/day

  8. Dietary intake (mothers) [ Time Frame: baseline -12 months ]
    food frequency questionnaire on salt intake; g/d

  9. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking

  10. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    questionnaire data: meeting physical activity recommendations

  11. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    questionnaire data: daily minutes of sitting on a non-weekend and weekend day

  12. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    accelerometer data: daily number of steps

  13. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    accelerometer data: daily minutes of total and intensity-specific physical activity

  14. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    accelerometer data: daily minutes of stationary behavior

  15. Physical activity and sedentary behavior (mothers) [ Time Frame: baseline -12 months ]
    accelerometer data: daily number of breaks in stationary behavior

  16. Smoking (mothers) [ Time Frame: baseline -12 months ]
    questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day

  17. Laboratory assessment of cardiovascular risk (mothers) [ Time Frame: baseline -12 months ]
    lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)

  18. Laboratory assessment of cardiovascular risk (mothers) [ Time Frame: baseline -12 months ]
    hs-CRP; mg/l

  19. Laboratory assessment of cardiovascular risk (mothers) [ Time Frame: baseline -12 months ]
    HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5

  20. Awareness of later life morbidity (mothers) [ Time Frame: baseline -12 months ]
    A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity

  21. Heart rate variability (mothers) [ Time Frame: 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

  22. Blood pressure 24 hour variability (children) [ Time Frame: 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

  23. Arterial stiffness (children) [ Time Frame: baseline -12 months ]
    carotid-femoral pulse wave velocity; m/s

  24. Adiposity (children) [ Time Frame: baseline -12 months ]
    BMI z-score

  25. Adiposity (children) [ Time Frame: baseline -12 months ]
    waist-hip-ratio (no unit)

  26. Adiposity (children) [ Time Frame: baseline -12 months ]
    body fat percentage; %

  27. Dietary intake (children) [ Time Frame: 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)

  28. Physical activity and sedentary behavior (children) [ Time Frame: 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

  29. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    questionnaire data: weekly number of days and daily duration of active travel to school and hobbies

  30. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    questionnaire data: structured physical activity outside school hours

  31. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    questionnaire data: unstructured physical activity outside school hours

  32. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    questionnaire data: screen time and non-screen time sitting

  33. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    accelerometer data: daily number of steps

  34. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    accelerometer data: daily minutes of total and intensity-specific physical activity

  35. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    accelerometer data: daily minutes of stationary behavior

  36. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    accelerometer data: meeting physical activity recommendations

  37. Physical activity and sedentary behavior (children) [ Time Frame: baseline -12 months ]
    accelerometer data: daily number of breaks in stationary behavior

  38. Laboratory assessment of cardiovascular risk (children) [ Time Frame: baseline -12 months ]
    lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)

  39. Laboratory assessment of cardiovascular risk (children) [ Time Frame: baseline -12 months ]
    hs-CRP; mg/l

  40. Laboratory assessment of cardiovascular risk (children) [ Time Frame: baseline -12 months ]
    HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5

  41. Process evaluation: reach [ Time Frame: baseline ]
    participation rate of the families recruited (research database on study visits)

  42. Process evaluation: reach [ Time Frame: baseline ]
    representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)

  43. Process evaluation: compliance [ Time Frame: baseline -12 months ]
    participation rate in measurements (number of study visits and questionnaires completed)

  44. Process evaluation: compliance [ Time Frame: baseline -12 months ]
    proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)

  45. Process evaluation: acceptability [ Time Frame: baseline -12 months ]
    usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)

  46. Process evaluation: acceptability [ Time Frame: baseline -12 months ]
    credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)

  47. Process evaluation: acceptability [ Time Frame: baseline -12 months ]
    occurrence of technical problems (questionnaire)


Other Outcome Measures:
  1. Arterial wall thickness (mothers) [ Time Frame: baseline ]
    intima-media thickness; common carotid, brachial and radial; mm

  2. Left ventricular mass (mothers) [ Time Frame: baseline ]
    left ventricular mass; g

  3. Left ventricular systolic function (mothers) [ Time Frame: baseline ]
    left ventricular global longitudinal strain; %

  4. Left ventricular diastolic function (mothers) [ Time Frame: baseline ]
    left atrial volume; ml

  5. Left ventricular diastolic function (mothers) [ Time Frame: baseline ]
    pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)

  6. Left ventricular diastolic function (mothers) [ Time Frame: baseline ]
    mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s

  7. Left ventricular diastolic function (mothers) [ Time Frame: baseline ]
    septal pulsed wave tissue Doppler early velocity; cm/s

  8. Arterial wall thickness (children) [ Time Frame: baseline ]
    intima-media thickness; common carotid, brachial and radial; mm

  9. Left ventricular mass (children) [ Time Frame: baseline ]
    left ventricular mass; g

  10. Left ventricular systolic function (children) [ Time Frame: baseline ]
    left ventricular global longitudinal strain; %

  11. Left ventricular diastolic function (children) [ Time Frame: baseline ]
    left atrial volume; ml

  12. Left ventricular diastolic function (children) [ Time Frame: baseline ]
    pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)

  13. Left ventricular diastolic function (children) [ Time Frame: baseline ]
    mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s

  14. Left ventricular diastolic function (children) [ Time Frame: baseline ]
    septal pulsed wave tissue Doppler early velocity; cm/s



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676295


Contacts
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Contact: Tiina Jääskeläinen, PhD +358 50 4150274 tiina.j.jaaskelainen@helsinki.fi
Contact: Taisto Sarkola, PhD, MD +358504274971 taisto.sarkola@hus.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Taisto Sarkola, PhD, MD    +358504274971    taisto.sarkola@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
Investigators
Layout table for investigator information
Principal Investigator: Tiina Jääskeläinen, PhD University of Helsinki
Study Chair: Hannele Laivuori, Prof, MD University of Helsinki and University of Tampere
Study Director: Taisto Sarkola, PhD, MD Helsinki University Central Hospital
Publications of Results:
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Responsible Party: Tiina Jääskeläinen, Principal Investigator, University of Helsinki
ClinicalTrials.gov Identifier: NCT04676295    
Other Study ID Numbers: FINNCARE
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Cardiovascular Diseases
Hypertension
Vascular Diseases
Pregnancy Complications