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Physical Exercise Controls Gestational Weight Gain

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise group
Sponsored by
Technical University of Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Exercise, Aerobic, Resistance training, Pregnancy, Maternal weight gain, IOM recommendations

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish

Exclusion Criteria:

  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Sites / Locations

  • Universidad Politécnica de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

Sedentary pregnant women

Outcomes

Primary Outcome Measures

Maternal gestational weight gain
Maternal weight gain

Secondary Outcome Measures

Maternal gestational diabetes
Gestational diabetes
Fetal body mass index
Baby body Mass index (BMI)

Full Information

First Posted
February 4, 2013
Last Updated
March 13, 2013
Sponsor
Technical University of Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01790347
Brief Title
Physical Exercise Controls Gestational Weight Gain
Official Title
The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (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
An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..
Detailed Description
The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Exercise, Aerobic, Resistance training, Pregnancy, Maternal weight gain, IOM recommendations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Sedentary pregnant women
Intervention Type
Behavioral
Intervention Name(s)
Exercise group
Intervention Description
The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.
Primary Outcome Measure Information:
Title
Maternal gestational weight gain
Description
Maternal weight gain
Time Frame
40-42 weeks
Secondary Outcome Measure Information:
Title
Maternal gestational diabetes
Description
Gestational diabetes
Time Frame
From 24 to 26 week
Title
Fetal body mass index
Description
Baby body Mass index (BMI)
Time Frame
38-42 weeks
Other Pre-specified Outcome Measures:
Title
Gestational age
Description
Number of weeks of gestation at labor
Time Frame
36-42 weeks
Title
Fetal outcome
Description
Type of labor
Time Frame
36-42 weeks

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: Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines Being able to communicate in spanish Exclusion Criteria: Obstetrician complications Being interested in the study after 18 weeks Not being regular in physical exercise program Younger than 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Barakat, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Politécnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24290112
Citation
Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.
Results Reference
derived

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Physical Exercise Controls Gestational Weight Gain

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