Obesity, Overweight
Conditions
Keywords
pregnancy, obesity, physical exercise, quality of life
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.
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.
Interventions
OTHERphysical 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 counseling and prenatal care.
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref) | at the 14 and at the 40 gestational weeks | 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). |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| no Exercise The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling. | 42 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Physical Exercise | no Exercise | Total |
|---|---|---|---|
| Age Continuous | 29.7 years STANDARD_DEVIATION 6.8 | 30.9 years STANDARD_DEVIATION 5.9 | 30.1 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment Brazil | 40 participants | 42 participants | 82 participants |
| Sex: Female, Male Female | 40 Participants | 42 Participants | 82 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Gestational Weight Gain
Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy
Time frame: baseline and at 40 gestational weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Gestational Weight Gain | 10.3 kg | Standard Deviation 5 |
| no Exercise | Gestational Weight Gain | 11.5 kg | Standard Deviation 7.4 |
Comparison: The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.p-value: <0.05t-test, 1 sided
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
Time frame: at the 14 to 40 gestational weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Weight Gain During the Program | 7.7 kg | Standard Deviation 4.3 |
| no Exercise | Weight Gain During the Program | 8.1 kg | Standard Deviation 4.3 |
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).
Time frame: at the 14 and at the 40 gestational weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref) | 49.8 scores on a scale | Standard Deviation 17.1 |
| no Exercise | Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref) | 42.2 scores on a scale | Standard Deviation 16.1 |