- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02769897
Obesity in Schoolchildren of Basic Education - Phase III
2017년 8월 18일 업데이트: Miria Suzana Burgos, University of Santa Cruz do Sul
Obesity in Schoolchildren of Basic Education: a Study of Interdisciplinary Intervention - Phase III
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
50
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
10년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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 17years;
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
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.
다른 이름들:
|
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간섭 없음: Control group
The control group did not receive the intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body mass index (kg/m²)
기간: 6 months
|
Body mass index is measured by the weight and height values, applying the formula: weight/(height)²
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 5월 1일
기본 완료 (실제)
2016년 5월 1일
연구 완료 (실제)
2016년 11월 1일
연구 등록 날짜
최초 제출
2016년 5월 6일
QC 기준을 충족하는 최초 제출
2016년 5월 10일
처음 게시됨 (추정)
2016년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 18일
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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