OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03269513
• Other study ID #: UNISC
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 18, 2017
• Last updated: August 30, 2017
• Start date: August 23, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: August 2017
• Source: University of Santa Cruz do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 8, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Obesity
• Exercise
• Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• Physical Exercise
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.

Locations

Country	Name	City	State
Brazil	Universidade de Santa Cruz do Sul	Santa Cruz do Sul	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
University of Santa Cruz do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from body mass index (BMI) at 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 (	Baseline and 3 months.
Secondary	Change from the percentage of body fat at 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).	Baseline and 3 months.
Secondary	Change from the waist circumference (WC) at 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.	Baseline and 3 months.