Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
研究概览
详细说明
This programme will be conducted after obtaining prior permission from the Directorate of School Education, Government of Tamil Nadu and school authorities. This study will be conducted in 22 schools in Chennai involving 2815 students of age group 12 to 18 years. Initially the study and its procedure will be explained to the principal and the teachers of the school. Request the school authority to fix a date for each standard/grade to explain about the informed consent / assent form and the study process to the students. The students will be asked to give the informed consent/assent form to their parents and asked to get their signature in the specified place. Instruction will be given to the students that their parents can call the Investigator if they have any doubts in the informed consent/assent form. After giving ample time for the informed consent process the students will be asked to give the informed consent when the research team goes to the school. The informed consent should be countersigned by the teachers to confirm the authenticity of the parent's signature. The research team gets the signature from the student in the assent form. A date is finalized with the school authority for the screening. The students are advised to come in fasting for the test. On the day of screening the student will be given a screening number. Necessary details such as personal and family information, anthropometry (height, weight, waist circumference, body fat) and blood pressure will be measured. Medical history, diet, physical activity, and sleep habits and questionnaire on awareness on diabetes will be recorded. Laboratory investigations such as fasting blood glucose, plasma insulin and lipid profile (Total Cholesterol, Triglyceride, Low-Density Lipoprotein (LDL), Very Low-Density Lipoprotein (VLDL) and High-Density Lipoprotein (HDL)) will be measured.
After the assessment, the students will be given refreshments and a few minutes of rest. The samples will be sent to the central laboratory for analyses. The reports will be distributed to the students within a week's time. Parents will be personally contacted by the research team if there is any concern in the lab report which requires medical attention.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Tamil Nadu
-
Chennai、Tamil Nadu、印度、600008
- 招聘中
- India Diabetes Research Foundation
-
接触:
- Ambady Ramachandran, MD, PhD, DSc
-
首席研究员:
- Ambady Ramachandran, MD, PhD, DSc
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Children both boys and girls between 12 - 18yrs age group
- Parents and child willing to give informed consent
- Children must be available for and willing to attend all evaluation visits
- Willingness to follow the protocol requirements as evidenced by written informed consent
Exclusion Criteria:
- Children below the age of 12 years and above the age of 18 years
- Parents or Child who is not willing to participate in the study
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:横截面
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 |
---|---|---|
Prevalence of central adiposity
大体时间:baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
Prevalence of dysglycemia
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of dyslipidemia
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of hypertension
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of insulin resistance
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Prevalence of overweight
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of obesity
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in diet habit
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in duration of physical activity
大体时间:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
合作者和调查者
调查人员
- 首席研究员:Ambady Ramachandran, MD, PhD, DSc、Senior Research Officer
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.