Physical Exercise Program in Obese and Overweight Pregnant Women

Pregnancy Clinical Trial

Official title:

Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01753622
• Other study ID #: Overweight-obese pregnant
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2012
• Last updated: November 13, 2014
• Start date: October 2009
• Est. completion date: November 2015

Study information

• Verified date: December 2012
• Source: Technical University of Madrid
• Contact: María Perales, 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

Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.

Description:

The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2015
• Est. primary completion date: January 2013
• 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 Fuenlabrada

• Having a Body Mass Index (BMI) greater than 24.9

Exclusion Criteria:

• Multiparity

• Obstetrician complications

• Being interested in the study after 18 weeks

• Not being regular in physical exercise program (minimum adherence 80%)

• Younger than 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Pregnancy

Intervention

Behavioral:
• 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 maximal heart rate. 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 Politecnica 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
Other	Fetal weight	Birth weight (g.)	After labor	No
Primary	Change from level of depression at the end of the pregnancy	The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all obese and overweight pregnant women at the beginning and at the end of their pregnancies	Up to 36 weeks	No
Secondary	Maternal gestational weight gain	Maternal gain weight	40-42 weeks	No
Secondary	Maternal outcomes	Type of labor	After labor	No