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- Registre américain des essais cliniques
- Essai clinique NCT02109588
Early Prevention of Childhood Obesity: an Active Pregnancy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: María Perales Santaella, PhD student
- Numéro de téléphone: 913364081
- E-mail: m.perales.santaella@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Ruben Barakat, PhD
- Numéro de téléphone: 913364120
- E-mail: barakatruben@gmail.com
Lieux d'étude
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Madrid, Espagne, 28040
- Recrutement
- Universidad Politecnica de Madrid
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Contact:
- María Perales Santaella, PhD student
- Numéro de téléphone: 913364081
- E-mail: m.perales.santaella@gmail.com
-
Contact:
- Ruben Barakat, PhD
- Numéro de téléphone: 913364120
- E-mail: barakatruben@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Contrôle
Femmes enceintes sédentaires
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Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Body mass index of the offsprings
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: At delivery
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Placenta measurements were collected at labor
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At delivery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maternal outcomes
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Prevention childhood obesity
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Essais cliniques sur A supervised physical exercise program
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