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Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India

The prevalence of cardiometabolic risk is high among South Asians which manifests itself at an early age. Studies have reported that unhealthy food choices, inadequate physical activity and lack of awareness on healthy lifestyle practices pose a huge threat to the increasing prevalence of metabolic abnormalities even at adolescence. In an earlier study conducted in 2006, reported that 68% of the children during their early adolescence had one or more of the cardiometabolic abnormalities such as obesity, central adiposity, increased blood pressure and presence of dysglycaemia and dyslipidaemia. The risk escalated with increasing weight. Therefore, it is imperative to sensitize the children on improving their lifestyle by conducting screening tests and health education programmes in schools by involving teachers. The Investigator have also shown in a study that teachers can be instrumental in imparting knowledge on the prevention of non-communicable diseases such as diabetes by promoting healthy behavioral changes. The proposed study will focus on a) changes in the prevalence of cardiometabolic risk factors over a 10 year period b) health education programme to school children c) recommendations to school teachers (tool-kit) to inculcate improved lifestyle practices to their students.

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

观察性的

注册 (预期的)

2815

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

    • 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

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

12年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Children both boys and girls between 12 - 18yrs age group

描述

Inclusion Criteria:

  1. Children both boys and girls between 12 - 18yrs age group
  2. Parents and child willing to give informed consent
  3. Children must be available for and willing to attend all evaluation visits
  4. Willingness to follow the protocol requirements as evidenced by written informed consent

Exclusion Criteria:

  1. Children below the age of 12 years and above the age of 18 years
  2. Parents or Child who is not willing to participate in the study

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

  • 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

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:Ambady Ramachandran, MD, PhD, DSc、Senior Research Officer

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)

2019年8月1日

初级完成 (预期的)

2021年8月31日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2019年6月29日

首先提交符合 QC 标准的

2019年7月9日

首次发布 (实际的)

2019年7月11日

研究记录更新

最后更新发布 (实际的)

2020年11月24日

上次提交的符合 QC 标准的更新

2020年11月22日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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