Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women

Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women

Patrocinadores

Patrocinador principal: Hvidovre University Hospital

Fuente Hvidovre University Hospital
Resumen breve

Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

Descripción detallada

Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.

The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)

Estado general Completed
Fecha de inicio April 2009
Fecha de Terminación June 2012
Fecha de finalización primaria June 2012
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Maternal weight gain At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Resultado secundario
Medida Periodo de tiempo
Pregnancy complications At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Glucose tolerance in pregnancy At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Birth weight At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Inscripción 420
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Diet + Exercise

Descripción: Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Otro nombre: Lifestyle intervention.

Elegibilidad

Criterios:

Inclusion Criteria:

- Age >18 years

- BMI > 30

- Singleton pregnancy

- Must speak and understand Danish

Exclusion Criteria:

- Alcohol or drug abuse

- Diabetes type I or other critical medical disease.

Género: Female

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Ubicación
Instalaciones: Department of Obstetrics and Gynecology, Hvidovre University Hospital
Ubicacion Paises

Denmark

Fecha de verificación

September 2012

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Hvidovre University Hospital

Nombre completo del investigador: Kristina Renault

Título del investigador: MD

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Diet + Exercise

Tipo: Experimental

Descripción: Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Etiqueta: Exercise

Tipo: Experimental

Descripción: Exercise: Individual counselling

Etiqueta: Control

Tipo: No Intervention

Descripción: Standard treatment without intervention.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov