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Clinical Trials/NCT03269513
NCT03269513
Unknown
N/A

OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study Interdisciplinary Intervention - Phase III

University of Santa Cruz do Sul1 site in 1 country60 target enrollmentAugust 23, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Santa Cruz do Sul
Enrollment
60
Locations
1
Primary Endpoint
Change from body mass index (BMI) at 3 months
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2017
End Date
December 8, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Santa Cruz do Sul
Responsible Party
Principal Investigator
Principal Investigator

Miria Suzana Burgos

Principal Investigator

University of Santa Cruz do Sul

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;

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Change from the waist circumference (WC) at 3 months(Baseline and 3 months.)
  • Change from the percentage of body fat at 3 months(Baseline and 3 months.)

Study Sites (1)

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