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

Birth-weight Clinical Trial

Official title:

Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506310
• Other study ID #: sbo2010
• Status: Completed
• Phase: Phase 3
• First received: December 26, 2011
• Last updated: January 22, 2013
• Start date: July 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Birth-weight
• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• 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.

Other:
• Exercise
The exercise groups will be advised to walk at least 20-minute a day.
• 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

Locations

Country	Name	City	State
Italy	University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum fasting glucose values.	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)	No
Secondary	Serum fasting insulin values	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)	No
Secondary	The need for insulin therapy	The need for insulin therapy in each arm	At recruitment and at the end of follow-up (38 weeks)	No
Secondary	The number of Cesarean sections	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	No
Secondary	The mean birth-weight of newborns	The mean birth-weight of newborns in each arm	From recruitment until the date of delivery, assessed up to 42 weeks	No

External Links

•   site for randomization