Gestational Diabetes: the Prevention

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Exercise group

• Registration Number: NCT01790412
• Lead Sponsor: Technical University of Madrid

Brief Summary

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.

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 Timeline

• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-11
• Last Update Submitted: 2013-02-11
• Study First Posted: 2013-02-13
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise group	Three sessions per week: Supervised exercise program

Primary Outcome Measures

Name	Time	Method
prevention gestational diabetes	weeks 24-30	Oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Maternal weight gain	weeks 40-42	Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)

Trial Locations

Locations (1)

Technical University of Madrid; 🇪🇸 Madrid, Spain