Early Prevention of Childhood Obesity: an Active Pregnancy

Pregnancy Clinical Trial

Official title:

Early Prevention of Childhood Obesity: an Active Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02109588
• Other study ID #: Prevention childhood obesity
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: November 13, 2014
• Start date: March 2014
• Est. completion date: April 2018

Study information

• Verified date: October 2013
• Source: Technical University of Madrid
• Contact: Maria Perales Santaella, PhD student
• Phone: 913364081
• Email: m.perales.santaella[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: April 2018
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pediatric Obesity
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Politécnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index of the offsprings	Body mass index was measured several times from 0 to 24 months	0-24 postpartum months	No
Primary	Fetus body composition	Fetus body composition (percentage of fat) was measured several times from 0 to 24 months	0-24 postpartum months	No
Primary	Change from baseline in Maternal gestational weight gain	Maternal weight gain during pregnancy	40-42 weeks of gestation	No
Primary	Changes in Baby motor development	Baby motor development was measured after delivery	0-24 postpartum months	No
Primary	Recovery time to pre-gestational weight	The time needed to recovery the pre-gestational weight was assessed.	6-12 postpartum months	No
Primary	Glycemia level of the offsprings	Glycemia level of the offsprings was measured until 24 months	0-24 postpartum months	No
Primary	Postpartum depression	The level of maternal depression was measured after delivery	0-12 postpartum months	No
Primary	Change from baseline in Body image satisfaction	Body image satisfaction was measured during and after pregnancy	up to 36 weeks	No
Primary	Changes from baseline in maternal quality of life	Maternal quality of life was measured during and after pregnancy	up to 36 weeks	No
Primary	Placenta measurements	Placenta measurements were collected at labor	At delivery	No
Secondary	Maternal outcomes	Type of labor, stage of labor and some other maternal variables were measured at delivery	At delivery	Yes
Secondary	Control of physical activity	Control the level of physical activity during and after pregnancy	up to 10 weeks	No
Secondary	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	No
Secondary	Fetus outcomes	Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference	At delivery	Yes