Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
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Turin, Italie, 10126
- University of Turin
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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:
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Exclusion Criteria:
- Body mass index > 40 or < 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Exercer
|
The exercise groups will be advised to walk at least 20-minute a day.
|
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Aucune intervention: Diet alone
|
|
|
Expérimental: Behavioral therapy
|
General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
A brief written guide on behavior change.
|
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Expérimental: Behavioral therapy and exercise
|
General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. Written recommendations for physical activity A brief written guide on behavior change |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum fasting glucose values.
Délai: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
|
Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum fasting insulin values
Délai: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
To investigate changes from baseline in serum fasting insulin values in each arm.
|
At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
|
The need for insulin therapy
Délai: At recruitment and at the end of follow-up (38 weeks)
|
The need for insulin therapy in each arm
|
At recruitment and at the end of follow-up (38 weeks)
|
|
The number of Cesarean sections
Délai: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
|
The number of Cesarean sections in each arm
|
From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
|
|
The mean birth-weight of newborns
Délai: From recruitment until the date of delivery, assessed up to 42 weeks
|
The mean birth-weight of newborns in each arm
|
From recruitment until the date of delivery, assessed up to 42 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- sbo2010
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