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出境医 / 临床实验 / Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India

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

Study Description
Brief Summary:
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.

Condition or disease
Obesity Dysglycemia Dyslipidemias Hypertension Insulin Resistance

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 2815 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Prevalence of central adiposity [ Time Frame: baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  2. Prevalence of dysglycemia [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  3. Prevalence of dyslipidemia [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  4. Prevalence of hypertension [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  5. Prevalence of insulin resistance [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data


Secondary Outcome Measures :
  1. Prevalence of overweight [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  2. Prevalence of obesity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  3. Changes in diet habit [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data

  4. Changes in duration of physical activity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children both boys and girls between 12 - 18yrs age group
Criteria

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
Contacts and Locations

Contacts
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Contact: Ambady Ramachandran, MD, PhD, DSc 04422353730 research@ardiabetes.org

Locations
Layout table for location information
India
India Diabetes Research Foundation Recruiting
Chennai, Tamil Nadu, India, 600008
Contact: Ambady Ramachandran, MD, PhD, DSc         
Principal Investigator: Ambady Ramachandran, MD, PhD, DSc         
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Ambady Ramachandran, MD, PhD, DSc Senior Research Officer
Tracking Information
First Submitted Date June 29, 2019
First Posted Date July 11, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
  • Prevalence of central adiposity [ Time Frame: baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of dysglycemia [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of dyslipidemia [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of hypertension [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of insulin resistance [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2019)
  • Prevalence of overweight [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of obesity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Changes in diet habit [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Changes in duration of physical activity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
Original Secondary Outcome Measures
 (submitted: July 9, 2019)
  • Prevalence of overweight [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Prevalence of obesity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Changes in Calories, carbohydrate and fat intake [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
  • Changes in duration of physical activity [ Time Frame: Baseline ]
    Among adolescent children in 2019 in comparison with 2006 data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Official Title Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Brief Summary 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.
Detailed Description

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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children both boys and girls between 12 - 18yrs age group
Condition
  • Obesity
  • Dysglycemia
  • Dyslipidemias
  • Hypertension
  • Insulin Resistance
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2019) 		2815
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ambady Ramachandran, MD, PhD, DSc 04422353730 research@ardiabetes.org
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT04015726
Other Study ID Numbers IDRFARH012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Study Sponsor India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators Not Provided
Investigators
Principal Investigator: Ambady Ramachandran, MD, PhD, DSc Senior Research Officer
PRS Account India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Verification Date November 2020

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