NCT01790412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

3.8 years

First QC Date

February 5, 2013

Last Update Submit

February 11, 2013

Conditions

Pregnancy

Keywords

pregnancy, exercise, gestational diabetes

Outcome Measures

Primary Outcomes (1)

  • prevention gestational diabetes

    Oral glucose tolerance test (OGTT)

    weeks 24-30

Secondary Outcomes (1)

  • Maternal weight gain

    weeks 40-42

Other Outcomes (1)

  • Other pregnancy outcomes

    After delivery

Study Arms (2)

Exercise group

EXPERIMENTAL

Three sessions per week: Supervised exercise program

Behavioral: Exercise group

Control

NO INTERVENTION

Sedentary pregnant women

Interventions

Exercise groupBEHAVIORAL

Combined two land aerobic sessions and one aquatic activities session

Exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Madrid

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25333246DERIVED

MeSH Terms

Conditions

Motor ActivityDiabetes, Gestational

Condition Hierarchy (Ancestors)

BehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rubén Barakat, PhD

    Technical University of Madrid

    STUDY DIRECTOR

  • Yaiza Cordero, PhD Student

    Technical University of Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gestational Diabetes. The Role of Exercise in the Prevention

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 13, 2013

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

ES(1)