Back to resultsEarly Prevention of Childhood Obesity: an Active Pregnancy
Primary Purpose
Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A supervised physical exercise program
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy
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 Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Sites / Locations
- Universidad Politécnica de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Exercise group
Arm Description
Sedentary pregnant women
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 heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate
Outcomes
Primary Outcome Measures
Body mass index of the offsprings
Body mass index was measured several times from 0 to 24 months
Fetus body composition
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
Change from baseline in Maternal gestational weight gain
Maternal weight gain during pregnancy
Changes in Baby motor development
Baby motor development was measured after delivery
Recovery time to pre-gestational weight
The time needed to recovery the pre-gestational weight was assessed.
Glycemia level of the offsprings
Glycemia level of the offsprings was measured until 24 months
Postpartum depression
The level of maternal depression was measured after delivery
Change from baseline in Body image satisfaction
Body image satisfaction was measured during and after pregnancy
Changes from baseline in maternal quality of life
Maternal quality of life was measured during and after pregnancy
Placenta measurements
Placenta measurements were collected at labor
Secondary Outcome Measures
Maternal outcomes
Type of labor, stage of labor and some other maternal variables were measured at delivery
Control of physical activity
Control the level of physical activity during and after pregnancy
Changes from delivery in Health of the offspring
Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
Fetus outcomes
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
Full Information
NCT ID
NCT02109588
First Posted
March 31, 2014
Last Updated
November 13, 2014
Sponsor
Technical University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02109588
Brief Title
Early Prevention of Childhood Obesity: an Active Pregnancy
Official Title
Early Prevention of Childhood Obesity: an Active Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
April 2018 (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
The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.
Detailed Description
The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sedentary pregnant women
Arm Title
Exercise group
Arm Type
Experimental
Arm 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 heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate
Intervention Type
Behavioral
Intervention Name(s)
A supervised physical exercise program
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 heart rate reserve. 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
Body mass index of the offsprings
Description
Body mass index was measured several times from 0 to 24 months
Time Frame
0-24 postpartum months
Title
Fetus body composition
Description
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
Time Frame
0-24 postpartum months
Title
Change from baseline in Maternal gestational weight gain
Description
Maternal weight gain during pregnancy
Time Frame
40-42 weeks of gestation
Title
Changes in Baby motor development
Description
Baby motor development was measured after delivery
Time Frame
0-24 postpartum months
Title
Recovery time to pre-gestational weight
Description
The time needed to recovery the pre-gestational weight was assessed.
Time Frame
6-12 postpartum months
Title
Glycemia level of the offsprings
Description
Glycemia level of the offsprings was measured until 24 months
Time Frame
0-24 postpartum months
Title
Postpartum depression
Description
The level of maternal depression was measured after delivery
Time Frame
0-12 postpartum months
Title
Change from baseline in Body image satisfaction
Description
Body image satisfaction was measured during and after pregnancy
Time Frame
up to 36 weeks
Title
Changes from baseline in maternal quality of life
Description
Maternal quality of life was measured during and after pregnancy
Time Frame
up to 36 weeks
Title
Placenta measurements
Description
Placenta measurements were collected at labor
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Maternal outcomes
Description
Type of labor, stage of labor and some other maternal variables were measured at delivery
Time Frame
At delivery
Title
Control of physical activity
Description
Control the level of physical activity during and after pregnancy
Time Frame
up to 10 weeks
Title
Changes from delivery in Health of the offspring
Description
Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
Time Frame
0-24 postpartum months
Title
Fetus outcomes
Description
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
Time Frame
At 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:
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 Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Exclusion Criteria:
Multiparity
Obstetrician complications
Being interested in the study after 16 weeks
Not being regular in physical exercise program
Younger than 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Perales Santaella, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rubén Barakat, PhD
Phone
913364120
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 Politécnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Perales Santaella, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
First Name & Middle Initial & Last Name & Degree
Rubén Barakat, PhD
Phone
913364120
Email
barakatruben@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Early Prevention of Childhood Obesity: an Active Pregnancy
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