- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02109588
Early Prevention of Childhood Obesity: an Active Pregnancy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28040
- Reclutamiento
- Universidad Politécnica de Madrid
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Contacto:
- María Perales Santaella, PhD student
- Número de teléfono: 913364081
- Correo electrónico: m.perales.santaella@gmail.com
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Contacto:
- Ruben Barakat, PhD
- Número de teléfono: 913364120
- Correo electrónico: barakatruben@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
Embarazadas sedentarias
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Experimental: Exercise group
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body mass index of the offsprings
Periodo de tiempo: 0-24 postpartum months
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Body mass index was measured several times from 0 to 24 months
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0-24 postpartum months
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Fetus body composition
Periodo de tiempo: 0-24 postpartum months
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Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
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0-24 postpartum months
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Change from baseline in Maternal gestational weight gain
Periodo de tiempo: 40-42 weeks of gestation
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Maternal weight gain during pregnancy
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40-42 weeks of gestation
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Changes in Baby motor development
Periodo de tiempo: 0-24 postpartum months
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Baby motor development was measured after delivery
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0-24 postpartum months
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Recovery time to pre-gestational weight
Periodo de tiempo: 6-12 postpartum months
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The time needed to recovery the pre-gestational weight was assessed.
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6-12 postpartum months
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Glycemia level of the offsprings
Periodo de tiempo: 0-24 postpartum months
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Glycemia level of the offsprings was measured until 24 months
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0-24 postpartum months
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Postpartum depression
Periodo de tiempo: 0-12 postpartum months
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The level of maternal depression was measured after delivery
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0-12 postpartum months
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Change from baseline in Body image satisfaction
Periodo de tiempo: up to 36 weeks
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Body image satisfaction was measured during and after pregnancy
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up to 36 weeks
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Changes from baseline in maternal quality of life
Periodo de tiempo: up to 36 weeks
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Maternal quality of life was measured during and after pregnancy
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up to 36 weeks
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Placenta measurements
Periodo de tiempo: At delivery
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Placenta measurements were collected at labor
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At delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal outcomes
Periodo de tiempo: At delivery
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Type of labor, stage of labor and some other maternal variables were measured at delivery
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At delivery
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Control of physical activity
Periodo de tiempo: up to 10 weeks
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Control the level of physical activity during and after pregnancy
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up to 10 weeks
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Changes from delivery in Health of the offspring
Periodo de tiempo: 0-24 postpartum months
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Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
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0-24 postpartum months
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Fetus outcomes
Periodo de tiempo: At delivery
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Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
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At delivery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- Prevention childhood obesity
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