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Physical Exercise Program in Obese and Overweight Pregnant Women

Primary Purpose

Pregnancy

Status
Unknown status
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 Overweight, obese, pregnant, depression, outcomes

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
  • Giving birth at Hospital Universitario de Fuenlabrada
  • Having a Body Mass Index (BMI) greater than 24.9

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program (minimum adherence 80%)
  • Younger than 18 years old

Sites / Locations

  • Universidad Politecnica de MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Exercise group

Arm Description

Sedentary Obese and overweight pregnant women

Physical exercise program

Outcomes

Primary Outcome Measures

Change from level of depression at the end of the pregnancy
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all obese and overweight pregnant women at the beginning and at the end of their pregnancies

Secondary Outcome Measures

Maternal gestational weight gain
Maternal gain weight
Maternal outcomes
Type of labor

Full Information

First Posted
December 17, 2012
Last Updated
November 13, 2014
Sponsor
Technical University of Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01753622
Brief Title
Physical Exercise Program in Obese and Overweight Pregnant Women
Official Title
Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2015 (Anticipated)

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
Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.
Detailed Description
The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Overweight, obese, pregnant, depression, outcomes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Sedentary Obese and overweight pregnant women
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Physical exercise program
Intervention Type
Behavioral
Intervention Name(s)
Exercise group
Intervention Description
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise, 10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
Primary Outcome Measure Information:
Title
Change from level of depression at the end of the pregnancy
Description
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all obese and overweight pregnant women at the beginning and at the end of their pregnancies
Time Frame
Up to 36 weeks
Secondary Outcome Measure Information:
Title
Maternal gestational weight gain
Description
Maternal gain weight
Time Frame
40-42 weeks
Title
Maternal outcomes
Description
Type of labor
Time Frame
After labor
Other Pre-specified Outcome Measures:
Title
Fetal weight
Description
Birth weight (g.)
Time Frame
After labor

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 Giving birth at Hospital Universitario de Fuenlabrada Having a Body Mass Index (BMI) greater than 24.9 Exclusion Criteria: Multiparity Obstetrician complications Being interested in the study after 18 weeks Not being regular in physical exercise program (minimum adherence 80%) Younger than 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Perales, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Barakat, PhD
Phone
913364020
Email
barakatruben@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Barakat, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Politecnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Perales, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruben Barakat, PhD
Phone
913364020
Email
barakatruben@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Perales, PhD student

12. IPD Sharing Statement

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Physical Exercise Program in Obese and Overweight Pregnant Women

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