Early Prevention of Childhood Obesity: an Active Pregnancy

Not Applicable

• Conditions: Pregnancy

• Registration Number: NCT02109588
• Lead Sponsor: Technical University of Madrid

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.

Study Timeline

• Status Verified: 2013-10
• Study Start: 2014-03
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Primary Completion: 2014-08
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal outcomes	At delivery	Type of labor, stage of labor and some other maternal variables were measured at delivery
Control of physical activity	up to 10 weeks	Control the level of physical activity during and after pregnancy
Changes from delivery in Health of the offspring	0-24 postpartum months	Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
Fetus outcomes	At delivery	Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference

Trial Locations

Locations (1)

Universidad Politécnica de Madrid; 🇪🇸 Madrid, Spain