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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical exercise | Other | exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling |
|
| no exercise | No Intervention | Routine prenatal care and nutritional counseling. No exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at the 14 and at the 40 gestational weeks |
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda Surita, MD, PhD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atenção Integral à saúde da mulher | Campinas | São Paulo | 13083811 | Brazil | ||
| Centro de atenção integral à saúde da mulher - CAISM |
The entire study protocol was explained to these women and a written informed consent term was obtained. Subsequently, the women were randomly assigned to two groups: 1) one exercised under supervision and received home exercise counseling (study group) and 2) the other followed the prenatal routine of the service (control group).
A randomized controlled clinical trial was conducted with pregnant women seen at the Prenatal Outpatient Clinic of the Women's Integral Healthcare Center (CAISM-UNICAMP) from August 2008 to August 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Exercise | 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 and prenatal care. |
| FG001 | no Exercise | The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Exercise | 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 and prenatal care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gestational Weight Gain | Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy | Posted | Mean | Standard Deviation | kg | baseline and at 40 gestational weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Exercise | 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 and prenatal care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernanda Garanhani de Castro Surita | Department of Obstetrics and Gynecology - University of Campinas | +551935219304 | surita@unicamp.br |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Campinas |
| São Paulo |
| 13083881 |
| Brazil |
| BG001 | no Exercise | The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
|
|
|
| Primary | 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 | Posted | Aug 2010 | Mean | Standard Deviation | kg | at the 14 to 40 gestational weeks |
|
|
|
| Secondary | 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). | Posted | Aug 2010 | Mean | Standard Deviation | scores on a scale | at the 14 and at the 40 gestational weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | no Exercise | The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling. | 0 | 42 | 0 | 42 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |