Gestational Diabetes: the Prevention

NCT ID: NCT01790412

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise group

Three sessions per week:

Supervised exercise program

Group Type EXPERIMENTAL

Exercise group

Intervention Type BEHAVIORAL

Combined two land aerobic sessions and one aquatic activities session

Control

Sedentary pregnant women

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise group

Combined two land aerobic sessions and one aquatic activities session

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Madrid

OTHER

Sponsor Role lead

Responsible Party

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Yaiza Cordero Rodríguez

Gestational Diabetes. The Role of Exercise in the Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubén Barakat, PhD

Role: STUDY_DIRECTOR

Technical University of Madrid

Yaiza Cordero, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Technical University of Madrid

Locations

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Technical University of Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Cordero Y, Mottola MF, Vargas J, Blanco M, Barakat R. Exercise Is Associated with a Reduction in Gestational Diabetes Mellitus. Med Sci Sports Exerc. 2015 Jul;47(7):1328-33. doi: 10.1249/MSS.0000000000000547.

Reference Type DERIVED
PMID: 25333246 (View on PubMed)

Other Identifiers

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Technical University of Madrid

Identifier Type: -

Identifier Source: org_study_id

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