ObesityNCT01136291
Physical Exercise Influence Among Overweight and Obese Pregnant Women
A study testing physical exercise in people with Obesity and Overweight, run by University of Campinas, Brazil at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Atenção Integral à saúde da mulher
Campinas, São Paulo, 13083811
Centro de atenção integral à saúde da mulher - CAISM
Campinas, São Paulo, 13083881
About this study
Official title: Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:
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.
Read the detailed description
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
- Being tested
- physical exercise
- Keywords
- pregnancy, obesity, physical exercise, quality of life
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| physical exercise | Other | exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling Receives: Other: physical exercise |
| no exercise | No intervention | Routine prenatal care and nutritional counseling. No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy
Measured: 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
Measured: at the 14 to 40 gestational weeks
Secondary outcomes (1)
Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).
Measured: at the 14 and at the 40 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Fernanda Surita, MD, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136291
- Sponsor's protocol ID
- exerciseobesitypregnancy
- Status last verified
- Mar 2011
- First submitted
- 21 May 2010
- Last updated
- 23 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:
- ClinicalTrials.gov ID
- NCT01136291
- Acronym / sponsor ID
- exerciseobesitypregnancy
- Conditions
- Obesity, Overweight
- Keywords
- pregnancy, obesity, physical exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 23 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical exercise | Other | Other: physical exerciseexercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling |
| no exercise | No intervention | –Routine prenatal care and nutritional counseling. No exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exerciseThe 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. | Other | physical exercise |
Primary outcome
Gestational Weight Gain
Time frame: baseline and at 40 gestational weeks
Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy
Weight Gain During the Program
Time frame: at the 14 to 40 gestational weeks
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
1 secondary outcome
Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
Time frame: at the 14 and at the 40 gestational weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Surita, MD, PhD principal investigator
University of Campinas, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Obesity and Overweight, run by University of Campinas, Brazil at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: baseline and at 40 gestational weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.