Early Prevention of Childhood Obesity: an Active Pregnancy

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: A supervised physical exercise program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Universidad Politécnica de Madrid
    • Contact: María Perales Santaella, PhD student; Phone Number: 913364081; Email: m.perales.santaella@gmail.com
    • Contact: Ruben Barakat, PhD; Phone Number: 913364120; Email: barakatruben@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Sedentary pregnant women
Experimental: Exercise group; 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	Behavioral: A supervised physical exercise program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index of the offsprings	Body mass index was measured several times from 0 to 24 months	0-24 postpartum months
Fetus body composition	Fetus body composition (percentage of fat) was measured several times from 0 to 24 months	0-24 postpartum months
Change from baseline in Maternal gestational weight gain	Maternal weight gain during pregnancy	40-42 weeks of gestation
Changes in Baby motor development	Baby motor development was measured after delivery	0-24 postpartum months
Recovery time to pre-gestational weight	The time needed to recovery the pre-gestational weight was assessed.	6-12 postpartum months
Glycemia level of the offsprings	Glycemia level of the offsprings was measured until 24 months	0-24 postpartum months
Postpartum depression	The level of maternal depression was measured after delivery	0-12 postpartum months
Change from baseline in Body image satisfaction	Body image satisfaction was measured during and after pregnancy	up to 36 weeks
Changes from baseline in maternal quality of life	Maternal quality of life was measured during and after pregnancy	up to 36 weeks
Placenta measurements	Placenta measurements were collected at labor	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal outcomes	Type of labor, stage of labor and some other maternal variables were measured at delivery	At delivery
Control of physical activity	Control the level of physical activity during and after pregnancy	up to 10 weeks
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	0-24 postpartum months
Fetus outcomes	Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference	At delivery

Collaborators and Investigators

• Sponsor: Technical University of Madrid

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Prevention childhood obesity