Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)

Phase 3

Completed

• Conditions: Birth-weight
• Interventions: Behavioral: Behavioral therapy; Other: Exercise; Other: Behavioral therapy and exercise

• Registration Number: NCT01506310
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-12-26
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Behavioral therapy	Behavioral therapy	-
Exercise	Exercise	-
Behavioral therapy and exercise	Behavioral therapy and exercise	-

Primary Outcome Measures

Name	Time	Method
Serum fasting glucose values.	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.

Secondary Outcome Measures

Name	Time	Method
Serum fasting insulin values	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.
The need for insulin therapy	At recruitment and at the end of follow-up (38 weeks)	The need for insulin therapy in each arm
The number of Cesarean sections	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
The mean birth-weight of newborns	From recruitment until the date of delivery, assessed up to 42 weeks	The mean birth-weight of newborns in each arm

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, Italy