OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017
OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study Interdisciplinary Intervention - Phase III
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
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Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96815900
- Universidade de Santa Cruz do Sul
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The official signing the informed consent and informed;
- The student with 12 years or older must sign the consent term;
- Age range: 10 to 17;
- Gender: male and female;
- No contraindications for blood collection;
- No distinction in relation to social class, ethnicity or color;
- To have a BMI greater than 85th percentile;
- Do not be participating in any other exercise program and dietary intervention;
- Participate in the clarification meetings on the project, when the head of the student is committed to the project, the following: a) assume responsibility for bringing to the UNISC (building 42) and refer to their home, the participant student of this study, both in the days of assessment (testing and completion of the data collection instruments), as in the days of intervention: 2nd, 4th and 6th fairs, from 14h to 16h, including 15 minutes in advance to the host, call and guidance students;
- Participate in intervention sessions during the period of 2 hours daily, the established days, following the guidelines given by the coordination of the project and the professionals of Physical Education, Nutrition, Psychology, Pharmacy, Physiotherapy, Medicine, Nursing and / or another area of health / education that can contribute to achieving the objectives of the intervention project;
- Participate in the assessments and reassessments as protocols established by the project.
Exclusion Criteria:
- Students who submit a frequency less than 70% stake in the intervention;
- Students who present contraindication to the practice of physical activity during the program implementation period;
- Students who choose not to continue with the treatment of intervention proposed by the program;
Be in possession of any kind of illness, abnormality or health problem such as:
- Hypertension untreated, Kidney diseases, Cardiac disorders, chronic renal failure, genetic diseases that have congenital malformations and mental retardation as Turner syndrome, Klinefelter syndrome and Down syndrome or cognitive impairment. And do not be carrying transmitted diseases vertically (from mother to child) with anatomical deformations caused by the interference of the pathogenic agent in the development process, as Congenital Toxoplasmosis (hydrocephalus, cerebral calcification, mental retardation, acute myocarditis, retinochoroiditis, strabismus, microphthalmia ), Rubella Syndrome, congenital (deafness, congenital cataracts, heart defects, microcephaly and mental retardation) congenital Syphilis (bone deformities, keratitis, deafness and mental retardation), cytomegalovirus infection congenital (microcephaly, intracranial calcifications and sensorineural deafness), because these subjects they need special care medical and/or service people trained for the specific purposes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
Adolescent Obesity The exercise program, nutritional counseling and oral health will last for five to three months and will be held in the gym and rooms of the University of Santa Cruz do Sul (UNISC). The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week. |
The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from body mass index (BMI) at 3 months
Time Frame: Baseline and 3 months.
|
Weight and height will be evaluated early in the morning in a fasting state, with the student wearing light clothing and shoes.
The BMI will be classified as normal BMI, overweight or obesity.The BMI will be classified according to the percentage curves of the Centers for Disease Control and Prevention / National Center for Health Statistics (CDC/NCHS) (2010) according to gender and age, considering the low weight (<p5), normal weight (p5 and <p85), overweight (p 85 and <p 95) and obesity (p 95).
|
Baseline and 3 months.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from the percentage of body fat at 3 months
Time Frame: Baseline and 3 months.
|
To measure body fat percentage (BF%), a Lange (Beta Technology Incorporated) compass will be used to measure triceps and subscapular skinfolds.
The equation of Slaughter et al. (1998) will be applied, and data will be classified according to Lonman's data, as mentioned by Heyward and Stolarczyk (2000).
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Baseline and 3 months.
|
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Change from the waist circumference (WC) at 3 months
Time Frame: Baseline and 3 months.
|
Waist circumference (WC) was measured with an inelastic tape, using the narrowest part of the trunk between the ribs and the iliac crest and the hip at the greater trochanter level as references.
The subjects were then classified according to Taylor et al. (2000), defining the normal circumference percentile as <80 and obesity percentile as >80 according to gender and age.
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Baseline and 3 months.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Miria S Burgos, Dra, Universidade de Santa Cruz do Sul
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UNISC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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