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

January 22, 2013 updated by: Simona Bo, University of Turin, Italy

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Other: Exercise
The exercise groups will be advised to walk at least 20-minute a day.
No Intervention: Diet alone
Experimental: Behavioral therapy
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.
Experimental: Behavioral therapy and exercise
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum fasting glucose values.
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum fasting insulin values
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sbo2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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