NCT02109588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 14, 2014

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

March 31, 2014

Last Update Submit

November 13, 2014

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (4)

  • 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 Arms (2)

Control

NO INTERVENTION

Sedentary pregnant women

Exercise group

EXPERIMENTAL

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

Interventions

A supervised physical exercise programBEHAVIORAL

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

Exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 16 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Study Officials

  • Rubén Barakat, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Central Study Contacts

Maria Perales Santaella, PhD student

CONTACT

913364081m.perales.santaella@gmail.com

Rubén Barakat, PhD

CONTACT

913364120barakatruben@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

April 1, 2018

Last Updated

November 14, 2014

Record last verified: 2013-10

Locations

ES(1)