- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02048839
Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
SUBJECTS:
All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires
OVERALL OBJECTIVES:
- To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
- To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
- To study the association between gut microbiota and markers of offspring health
- To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
- To study the cost effectiveness of the intervention.
METHODS:
Maternal measurements
- Height, weight, waist and hip circumference
- Blood pressure, pulse
- Body fat percentage
- Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
- Fecal and hair samples
- Diurnal salivary cortisol assessment
- Background questionnaire: socioeconomic and health-related background
- Health-related quality of life (15-D).
- 3-day food diary and exercise diary
- ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
- Psychological questionnaires
- Pulse wave velocity (PWV) will be assessed
- Advanced glycation endproducts - a marker of cardiovascular health will be assessed
- Dental and oral health
- Bone health
- VHRU of arterial structure
Paternal measurements
- Background questionnaire (incl. height, weight, age)
- DNA-sample (buccal)
- 3-day food diary
- Psychological questionnaires
- Physical activity questionnaire (12 months)
Measurements of children
- Body weight, height, blood pressure, pulse
- Body fat percentage
- Psychological questionnaires
- Food and physical activities diaries
- ActiGraph, assessment of physical activity and sleep for 7 days
- Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
- Fecal, urine and hair samples
- A copy of child welfare center card (e.g. data on growth, immunizations, health)
- Endothelial function and pulse wave velocity (PWV)
- Bone health with peripheral CT
- Heart structure and function
- VHRU of arterial structure
TIMETABLE
Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Helsinki, Finlandia
- Helsinki University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- all study subjects form Radiel intervention study, who delivered a baby
Exclusion Criteria:
- none.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Radiel Intervention group and their children
Participated the Radiel- intervention study (2008-2011) in the Intervention group: Lifestyle counselling during and after pregnancy (up to 1 year post partum)
|
Radiel Control Group with their children
Control group in the Radiel- intervention study.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Type 2 Diabetes
Periodo de tiempo: 3-5 years post partum
|
3-5 years post partum
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Metabolic syndrome and cardiovascular morbidity
Periodo de tiempo: 3-5 years post partum
|
3-5 years post partum
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Obesity
Periodo de tiempo: 3-5 years post partum
|
3-5 years post partum
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Radiel 5Y
Información sobre medicamentos y dispositivos, documentos del estudio
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