OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017

NCT03269513 | Unknown DMC

• 1 other identifier: UNISC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Adolescent Obesity; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 (\<p5), normal weight (p5 and \<p85), overweight (p 85 and \<p 95) and obesity (p 95).

  Baseline and 3 months.

Secondary Outcomes (2)

• Change from the percentage of body fat at 3 months

  Baseline and 3 months.

• Change from the waist circumference (WC) at 3 months

  Baseline and 3 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Physical Exercise

Control group

NO INTERVENTION

Interventions

Physical Exercise BEHAVIORAL

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.

Also known as: Nutritional counseling, Psychological counseling

Intervention group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santa Cruz do Sul: lead

Study Sites (1)

Universidade de Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande do Sul, 96815900, Brazil

Location

MeSH Terms

Conditions

Obesity; Overweight; Pediatric Obesity; Motor Activity

Interventions

Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Miria S Burgos, Dra

  Universidade de Santa Cruz do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 31, 2017
• Study Start: August 23, 2017
• Primary Completion: November 23, 2017
• Study Completion: December 8, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

BR (1)