Back to resultsGestational Diabetes: the Prevention
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise group
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring pregnancy, exercise, gestational diabetes
Eligibility Criteria
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
Sites / Locations
- Technical University of Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control
Arm Description
Three sessions per week: Supervised exercise program
Sedentary pregnant women
Outcomes
Primary Outcome Measures
prevention gestational diabetes
Oral glucose tolerance test (OGTT)
Secondary Outcome Measures
Maternal weight gain
Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)
Full Information
NCT ID
NCT01790412
First Posted
February 5, 2013
Last Updated
February 11, 2013
Sponsor
Technical University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT01790412
Brief Title
Gestational Diabetes: the Prevention
Official Title
Gestational Diabetes. The Rol of Exercise in the Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
pregnancy, exercise, gestational diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Three sessions per week:
Supervised exercise program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sedentary pregnant women
Intervention Type
Behavioral
Intervention Name(s)
Exercise group
Intervention Description
Combined two land aerobic sessions and one aquatic activities session
Primary Outcome Measure Information:
Title
prevention gestational diabetes
Description
Oral glucose tolerance test (OGTT)
Time Frame
weeks 24-30
Secondary Outcome Measure Information:
Title
Maternal weight gain
Description
Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)
Time Frame
weeks 40-42
Other Pre-specified Outcome Measures:
Title
Other pregnancy outcomes
Description
macrosomia, type of delivery, birth weight
Time Frame
After delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Barakat, PhD
Organizational Affiliation
Technical University of Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yaiza Cordero, PhD Student
Organizational Affiliation
Technical University of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University of Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25333246
Citation
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.
Results Reference
derived
Learn more about this trial
Gestational Diabetes: the Prevention
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