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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Turin, Italia, 10126
- University of Turin
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ejercicio
|
The exercise groups will be advised to walk at least 20-minute a day.
|
|
Sin intervención: Diet alone
|
|
|
Experimental: 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.
|
|
Experimental: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum fasting glucose values.
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum fasting insulin values
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- sbo2010
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .