Physical Exercise Program in Obese and Overweight Pregnant Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial|
- Change from level of depression at the end of the pregnancy [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]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
- Maternal gestational weight gain [ Time Frame: 40-42 weeks ] [ Designated as safety issue: No ]Maternal gain weight
- Maternal outcomes [ Time Frame: After labor ] [ Designated as safety issue: No ]Type of labor
- Fetal weight [ Time Frame: After labor ] [ Designated as safety issue: No ]Birth weight (g.)
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
No Intervention: Control group
Sedentary Obese and overweight pregnant women
Experimental: Exercise group
Physical exercise program
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753622
|Contact: María Perales, PhD firstname.lastname@example.org|
|Contact: Ruben Barakat, PhDemail@example.com|
|Universidad Politecnica de Madrid||Recruiting|
|Madrid, Spain, 28040|
|Contact: Maria Perales, PhD student 913364081 firstname.lastname@example.org|
|Contact: Ruben Barakat, PhD 913364020 email@example.com|
|Principal Investigator: Maria Perales, PhD student|
|Study Director:||Rubén Barakat, PhD||Universidad Politécnica de Madrid|