Gestational Diabetes: the Prevention

February 11, 2013 updated by: Yaiza Cordero Rodríguez, Technical University of Madrid

Gestational Diabetes. The Rol of Exercise in the Prevention

To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Not Applicable

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

  • Spain
      • Madrid, Spain, 28040
        • Technical University of Madrid

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women
  • At week 8-14
  • Adherence 80% (minimum) until the end of pregnancy

Exclusion Criteria:

  • Contraindications appointed by American College of Obstetricians & Gynecologists (ACOG)
  • No adherence

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Sedentary pregnant women
Experimental: Exercise group

Three sessions per week:

Supervised exercise program
Behavioral: Exercise group
Combined two land aerobic sessions and one aquatic activities session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention gestational diabetes
Time Frame: weeks 24-30
Oral glucose tolerance test (OGTT)
weeks 24-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight gain
Time Frame: weeks 40-42
Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)
weeks 40-42

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other pregnancy outcomes
Time Frame: After delivery
macrosomia, type of delivery, birth weight
After delivery

Collaborators and Investigators

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

Sponsor

Technical University of Madrid

Investigators

  • Study Director: Rubén Barakat, PhD, Technical University of Madrid
  • Principal Investigator: Yaiza Cordero, PhD Student, Technical University of Madrid

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

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

February 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Technical University of Madrid

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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