- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015726
Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ambady Ramachandran, MD, PhD, DSc
- Phone Number: 04422353730
- Email: research@ardiabetes.org
Study Locations
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600008
- Recruiting
- India Diabetes Research Foundation
-
Contact:
- Ambady Ramachandran, MD, PhD, DSc
-
Principal Investigator:
- Ambady Ramachandran, MD, PhD, DSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of central adiposity
Time Frame: baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
Prevalence of dysglycemia
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of dyslipidemia
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of hypertension
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of insulin resistance
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of overweight
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of obesity
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in diet habit
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in duration of physical activity
Time Frame: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRFARH012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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