Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

14 de dezembro de 2020 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

400

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Finlândia
      • Helsinki, Finlândia, 00029
        • Recrutamento
        • Helsinki University Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PE intervention
A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.
Comportamental: 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.
Sem intervenção: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Blood pressure (mothers)
Prazo: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
baseline -12 months
Blood pressure (children)
Prazo: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
baseline -12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Blood pressure 24 hour variability (mothers)
Prazo: 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)
Prazo: baseline -12 months
carotid-femoral pulse wave velocity; m/s
baseline -12 months
Adiposity (mothers)
Prazo: baseline -12 months
BMI; kg/m2
baseline -12 months
Adiposity (mothers)
Prazo: baseline -12 months
waist-hip-ratio (no unit)
baseline -12 months
Adiposity (mothers)
Prazo: baseline -12 months
body fat percentage; %
baseline -12 months
Dietary intake (mothers)
Prazo: baseline -12 months
food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)
baseline -12 months
Dietary intake (mothers)
Prazo: baseline -12 months
food frequency questionnaire on fiber intake; g/day
baseline -12 months
Dietary intake (mothers)
Prazo: baseline -12 months
food frequency questionnaire on salt intake; g/d
baseline -12 months
Physical activity and sedentary behavior (mothers)
Prazo: 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)
Prazo: baseline -12 months
questionnaire data: meeting physical activity recommendations
baseline -12 months
Physical activity and sedentary behavior (mothers)
Prazo: 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)
Prazo: baseline -12 months
accelerometer data: daily number of steps
baseline -12 months
Physical activity and sedentary behavior (mothers)
Prazo: baseline -12 months
accelerometer data: daily minutes of total and intensity-specific physical activity
baseline -12 months
Physical activity and sedentary behavior (mothers)
Prazo: baseline -12 months
accelerometer data: daily minutes of stationary behavior
baseline -12 months
Physical activity and sedentary behavior (mothers)
Prazo: baseline -12 months
accelerometer data: daily number of breaks in stationary behavior
baseline -12 months
Smoking (mothers)
Prazo: 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)
Prazo: baseline -12 months
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
baseline -12 months
Laboratory assessment of cardiovascular risk (mothers)
Prazo: baseline -12 months
hs-CRP; mg/l
baseline -12 months
Laboratory assessment of cardiovascular risk (mothers)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: baseline -12 months
carotid-femoral pulse wave velocity; m/s
baseline -12 months
Adiposity (children)
Prazo: baseline -12 months
BMI z-score
baseline -12 months
Adiposity (children)
Prazo: baseline -12 months
waist-hip-ratio (no unit)
baseline -12 months
Adiposity (children)
Prazo: baseline -12 months
body fat percentage; %
baseline -12 months
Dietary intake (children)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: baseline -12 months
questionnaire data: structured physical activity outside school hours
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
questionnaire data: unstructured physical activity outside school hours
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
questionnaire data: screen time and non-screen time sitting
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
accelerometer data: daily number of steps
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
accelerometer data: daily minutes of total and intensity-specific physical activity
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
accelerometer data: daily minutes of stationary behavior
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
accelerometer data: meeting physical activity recommendations
baseline -12 months
Physical activity and sedentary behavior (children)
Prazo: baseline -12 months
accelerometer data: daily number of breaks in stationary behavior
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Prazo: baseline -12 months
lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Prazo: baseline -12 months
hs-CRP; mg/l
baseline -12 months
Laboratory assessment of cardiovascular risk (children)
Prazo: baseline -12 months
HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5
baseline -12 months
Process evaluation: reach
Prazo: baseline
participation rate of the families recruited (research database on study visits)
baseline
Process evaluation: reach
Prazo: baseline
representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)
baseline
Process evaluation: compliance
Prazo: baseline -12 months
participation rate in measurements (number of study visits and questionnaires completed)
baseline -12 months
Process evaluation: compliance
Prazo: 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
Prazo: baseline -12 months
usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)
baseline -12 months
Process evaluation: acceptability
Prazo: 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
Prazo: baseline -12 months
occurrence of technical problems (questionnaire)
baseline -12 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Arterial wall thickness (mothers)
Prazo: baseline
intima-media thickness; common carotid, brachial and radial; mm
baseline
Left ventricular mass (mothers)
Prazo: baseline
left ventricular mass; g
baseline
Left ventricular systolic function (mothers)
Prazo: baseline
left ventricular global longitudinal strain; %
baseline
Left ventricular diastolic function (mothers)
Prazo: baseline
left atrial volume; ml
baseline
Left ventricular diastolic function (mothers)
Prazo: baseline
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
baseline
Left ventricular diastolic function (mothers)
Prazo: baseline
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
baseline
Left ventricular diastolic function (mothers)
Prazo: baseline
septal pulsed wave tissue Doppler early velocity; cm/s
baseline
Arterial wall thickness (children)
Prazo: baseline
intima-media thickness; common carotid, brachial and radial; mm
baseline
Left ventricular mass (children)
Prazo: baseline
left ventricular mass; g
baseline
Left ventricular systolic function (children)
Prazo: baseline
left ventricular global longitudinal strain; %
baseline
Left ventricular diastolic function (children)
Prazo: baseline
left atrial volume; ml
baseline
Left ventricular diastolic function (children)
Prazo: baseline
pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)
baseline
Left ventricular diastolic function (children)
Prazo: baseline
mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s
baseline
Left ventricular diastolic function (children)
Prazo: baseline
septal pulsed wave tissue Doppler early velocity; cm/s
baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Helsinki University Central Hospital

Colaboradores

University of Helsinki

Investigadores

  • Investigador principal: Tiina Jääskeläinen, PhD, University of Helsinki
  • Cadeira de estudo: Hannele Laivuori, Prof, MD, University of Helsinki and University of Tampere
  • Diretor de estudo: Taisto Sarkola, PhD, MD, Helsinki University Central Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2019

Conclusão Primária (Antecipado)

1 de dezembro de 2022

Conclusão do estudo (Antecipado)

1 de dezembro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

7 de dezembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de dezembro de 2020

Primeira postagem (Real)

21 de dezembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de dezembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de dezembro de 2020

Última verificação

1 de dezembro de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FINNCARE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever