Obesity in Schoolchildren of Basic Education - Phase III
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|ClinicalTrials.gov Identifier: NCT02769897|
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : August 22, 2017
University of Santa Cruz do Sul
Information provided by (Responsible Party):
Miria Suzana Burgos, University of Santa Cruz do Sul
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 adolescents 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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Adolescent Behavior||Behavioral: Physical exercise||Not Applicable|
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, health-related physical fitness and motor performance in factors risk of cardiovascular disease, eating habits, cognition levels, psychological profile and body posture of adolescents with overweight and obesity. In addition, identify the effects of orientation for oral health on the quality of life and healthy oral habits. A quasi-experimental research will consist of a sample of approximately fifty adolescents with overweight and obesity, ages 10 to 17, of both sexes, selected voluntarily in two schools in Santa Cruz do Sul. The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral orientation) with a frequency of three times a week. The exercise session will consist of 10 minutes of warm-ups, 40 minutes of aerobic exercise, recreational and sports activities (moderate to severe) and 10 minutes back to calm, and the intensity of the activities will be monitored through a frequency (target heart rate: 60 to 70% of maximum heart rate of each subject). Nutritional, psychological, postural and oral guidance will be given by a nutritionist, psychologist, physiotherapist/physical education professional and odontologist respectively, which present lectures and educational games. The following parameters will be evaluated: anthropometric (BMI, waist circumference and skinfold thickness); hematologic and biochemical analysis (HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, glucose, insulin, adiponectin, leptin, resistin, C reative protein, ALT, AST, glycated hemoglobin, IL-6, IL-10, TNF-α, cortisol, irisina, F2 isoprostane and uric acid); polymorphism related to obesity (FTO rs9939609); related-health physical fitness (flexibility; sit and reach test; abdominal strength and cardiorespiratory fitness); postural deviations evaluated by the photogrammetry method - SAPO program. The nutritional habits and lifestyle will be assessed by self-report a validated and adapted questionnaire for Brazilian children and adolescents as well as a recall and diet calculation for nutrients through Virtual Nutri 1.0. Oral health will be evaluated according to the criteria of the SB Brazil Project 2010. The psychological and cognitive assessment will be done through instruments that determine self-esteem, body awareness, stress and possible mental health problems of adolescent. The results will be presented by means of statistical tests performed using SPSS 23.0. The comparison of the average values of variables between pre- and post-intervention will be carried out through the Anova test for repeated measures (generalized linear models), with subsequent calculation of the effect size; the two-way ANOVA is used to analyze the differences among the changes in the control group and the experimental group. Expected results: It is expected that after the completion of this research project, there are increases in the levels of cardiorespiratory fitness, flexibility and abdominal strength, changes in postural deviations and dietary habits, increased cognitive function and psychological aspects and improved hygiene and perception of oral health of adolescents with overweight and obesity and consequent reduction in rates of overweight and obesity and the risk factors of cardiovascular disease. The aim is to collaborate with public health policies in the prevention and treatment of overweight and obesity and consequences in schools.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Obesity in Schoolchildren of Basic Education: a Study of Interdisciplinary Intervention - Phase III|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Intervention group
The exercise program, nutritional counseling and oral health will last for five to six 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
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 Name: Nutritional counseling
No Intervention: Control group
The control group did not receive the intervention.
Primary Outcome Measures :
- Body mass index (kg/m²) [ Time Frame: 6 months ]Body mass index is measured by the weight and height values, applying the formula: weight/(height)²
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