Clinical trial NCT03269513: OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017
Official title: OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study Interdisciplinary Intervention - Phase III
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Adolescent Obesity
Exercise
Lead sponsor: University of Santa Cruz do Sul
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to evaluate the possible effects of an exercise program, nutritional and psychological, postural orientation and guidance of oral health on body composition, physical activity levels and lifestyle, physical fitness and health and motor performance, the factors risk of cardiovascular disease, eating habits, the cognition levels, the psychological profile, the body posture of children and adolescent with overweight and obesity, considering the presence of risk genotype associated with the development of obesity. In addition, identify the effects of orientation for oral health on the quality of life and healthy oral habits.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from body mass index (BMI) at 3 months
timeFrame: Baseline and 3 months.
Secondary outcomes:
measure: Change from the percentage of body fat at 3 months
timeFrame: Baseline and 3 months.
measure: Change from the waist circumference (WC) at 3 months
timeFrame: Baseline and 3 months.
Other outcomes:
Locations:
city: Santa Cruz do Sul
country: Brazil
facility: Universidade de Santa Cruz do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Universidade de Santa Cruz do Sul
name: Miria S Burgos, Dra
role: PRINCIPAL_INVESTIGATOR
References: