OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017
2017年8月30日 更新者:Miria Suzana Burgos、University of Santa Cruz do Sul
OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study 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 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.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Rio Grande do Sul
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Santa Cruz do Sul、Rio Grande do Sul、巴西、96815900
- Universidade de Santa Cruz do Sul
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:控制组
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实验性的:Intervention group
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. |
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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from body mass index (BMI) at 3 months
大体时间:Baseline and 3 months.
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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).
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Baseline and 3 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from the percentage of body fat at 3 months
大体时间:Baseline and 3 months.
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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).
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Baseline and 3 months.
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Change from the waist circumference (WC) at 3 months
大体时间:Baseline and 3 months.
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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.
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Baseline and 3 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Miria S Burgos, Dra、Universidade de Santa Cruz do Sul
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月23日
初级完成 (预期的)
2017年11月23日
研究完成 (预期的)
2017年12月8日
研究注册日期
首次提交
2017年8月18日
首先提交符合 QC 标准的
2017年8月30日
首次发布 (实际的)
2017年8月31日
研究记录更新
最后更新发布 (实际的)
2017年8月31日
上次提交的符合 QC 标准的更新
2017年8月30日
最后验证
2017年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Physical Exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的