Physical Exercise Program in Obese and Overweight Pregnant Women
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Technical University of Madrid.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Technical University of Madrid
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid
ClinicalTrials.gov Identifier:
NCT01753622
First received: December 17, 2012
Last updated: November 13, 2014
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Behavioral: Exercise group |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Technical University of Madrid:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
Other Outcome Measures:
- Fetal weight [ Time Frame: After labor ] [ Designated as safety issue: No ]Birth weight (g.)
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2015 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753622
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753622
Contacts
| Contact: María Perales, PhD student | 913364081 | m.perales.santaella@gmail.com | |
| Contact: Ruben Barakat, PhD | 913364020 | barakatruben@gmail.com |
Locations
| Spain | |
| Universidad Politecnica de Madrid | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Maria Perales, PhD student 913364081 m.perales.santaella@gmail.com | |
| Contact: Ruben Barakat, PhD 913364020 barakatruben@gmail.com | |
| Principal Investigator: Maria Perales, PhD student | |
Sponsors and Collaborators
Technical University of Madrid
Investigators
| Study Director: | Rubén Barakat, PhD | Universidad Politécnica de Madrid |
More Information
| Responsible Party: | María Perales Santaella, PhD student, Technical University of Madrid |
| ClinicalTrials.gov Identifier: | NCT01753622 History of Changes |
| Other Study ID Numbers: | Overweight-obese pregnant |
| Study First Received: | December 17, 2012 |
| Last Updated: | November 13, 2014 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Technical University of Madrid:
|
Overweight, obese, pregnant, depression, outcomes |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 23, 2016