Physical Exercise Influence Among Overweight and Obese Pregnant Women

NCT01136291 | Completed Results

• 1 other identifier: exerciseobesitypregnancy
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life. Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. They will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). Both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of pregnancy. The intervention results will be analyzed by intention to treat. A P value less than 0.05 will be used to determine statistical significance.

Conditions

Obesity; Overweight

Keywords

pregnancy; obesity; physical exercise; quality of life

Outcome Measures

Primary Outcomes (2)

• Gestational Weight Gain

  Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy

  baseline and at 40 gestational weeks

• Weight Gain During the Program

  Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams

  at the 14 to 40 gestational weeks

Secondary Outcomes (1)

• Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)

  at the 14 and at the 40 gestational weeks

Study Arms (2)

physical exercise

OTHER

exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling

Other: physical exercise

no exercise

NO INTERVENTION

Routine prenatal care and nutritional counseling. No exercise

Interventions

physical exercise OTHER

The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition counseling and prenatal care.

physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Overweight or obese (BMI ≥ 26 kg / m²), * Gestational age between 14 and 24 weeks and from age 18 years * No contraindication for physical exercise on pregnancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (2)

Centro de Atenção Integral à saúde da mulher

Campinas, São Paulo, 13083811, Brazil

Location

Centro de atenção integral à saúde da mulher - CAISM

Campinas, São Paulo, 13083881, Brazil

Location

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Fernanda Garanhani de Castro Surita
• Organization: Department of Obstetrics and Gynecology - University of Campinas

surita@unicamp.br

+551935219304

Study Officials

• Fernanda Surita, MD, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: June 3, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 23, 2011
• Results First Posted: February 23, 2011

Record last verified: 2011-03

Locations

BR (2)