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Clinical Trials/NCT02109588
NCT02109588
Unknown
N/A

Early Prevention of Childhood Obesity: an Active Pregnancy

Technical University of Madrid1 site in 1 country1,100 target enrollmentMarch 2014
ConditionsPregnancy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Technical University of Madrid
Enrollment
1100
Locations
1
Primary Endpoint
Placenta measurements
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
April 2018
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

María Perales Santaella

PhD student

Technical University of Madrid

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

Outcomes

Primary Outcomes

Placenta measurements

Time Frame: At delivery

Placenta measurements were collected at labor

Body mass index of the offsprings

Time Frame: 0-24 postpartum months

Body mass index was measured several times from 0 to 24 months

Fetus body composition

Time Frame: 0-24 postpartum months

Fetus body composition (percentage of fat) was measured several times from 0 to 24 months

Glycemia level of the offsprings

Time Frame: 0-24 postpartum months

Glycemia level of the offsprings was measured until 24 months

Recovery time to pre-gestational weight

Time Frame: 6-12 postpartum months

The time needed to recovery the pre-gestational weight was assessed.

Changes in Baby motor development

Time Frame: 0-24 postpartum months

Baby motor development was measured after delivery

Changes from baseline in maternal quality of life

Time Frame: up to 36 weeks

Maternal quality of life was measured during and after pregnancy

Change from baseline in Maternal gestational weight gain

Time Frame: 40-42 weeks of gestation

Maternal weight gain during pregnancy

Postpartum depression

Time Frame: 0-12 postpartum months

The level of maternal depression was measured after delivery

Change from baseline in Body image satisfaction

Time Frame: up to 36 weeks

Body image satisfaction was measured during and after pregnancy

Secondary Outcomes

  • Maternal outcomes(At delivery)
  • Control of physical activity(up to 10 weeks)
  • Changes from delivery in Health of the offspring(0-24 postpartum months)
  • Fetus outcomes(At delivery)

Study Sites (1)

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