ObesityNCT04015726
Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
An observational study of Obesity and Dysglycemia, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dysglycemia, Dyslipidemias
- How many people
- 2,815 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children both boys and girls between 12 - 18yrs age group
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
India Diabetes Research Foundation
Chennai, Tamil Nadu, 600008
Ambady Ramachandran, MD, PhD, DSc
Ambady Ramachandran, MD, PhD, DSc
About this study
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.
Read the 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.
- Conditions
- Obesity, Dysglycemia, Dyslipidemias, Hypertension, Insulin Resistance
- Medical subject headings
- Obesity, Dyslipidemias, Hypertension, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of central adiposity
Among adolescent children in 2019 in comparison with 2006 data
Measured: baseline
Prevalence of dysglycemia
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Prevalence of dyslipidemia
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Prevalence of hypertension
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Prevalence of insulin resistance
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Secondary outcomes (4)
Prevalence of overweight
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Prevalence of obesity
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Changes in diet habit
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Changes in duration of physical activity
Among adolescent children in 2019 in comparison with 2006 data
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,815 participants (estimated)
Sponsor and investigators
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ambady Ramachandran, MD, PhD, DSc, Principal investigator, Senior Research Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015726
- Sponsor's protocol ID
- IDRFARH012
- Status last verified
- Nov 2020
- First submitted
- 29 Jun 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nanditha R, Susairaj P, Satheesh K, Vinitha R, Snehalatha C, Ramachandran A. Increasing trend in prediabetes and obesity among adolescent school children in Chennai city in Southern India. Diabetes Metab Syndr. 2026 Jul 20;20(7):103457. doi: 10.1016/j.dsx.2026.103457. Online ahead of print.
PubMed 42526070
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
- ClinicalTrials.gov ID
- NCT04015726
- Acronym / sponsor ID
- IDRFARH012
- Conditions
- Obesity, Dysglycemia, Dyslipidemias, Hypertension, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,815 participants (estimated)
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children both boys and girls between 12 - 18yrs age group
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Prevalence of overweight
Time frame: Baseline
Prevalence of obesity
Time frame: Baseline
Changes in diet habit
Time frame: Baseline
Changes in duration of physical activity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 42526070Nanditha R, Susairaj P, Satheesh K, Vinitha R, Snehalatha C, Ramachandran A. Increasing trend in prediabetes and obesity among adolescent school children in Chennai city in Southern India. Diabetes Metab Syndr. 2026 Jul 20;20(7):103457. doi: 10.1016/j.dsx.2026.103457. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ambady Ramachandran, MD, PhD, DSc principal investigator
Senior Research Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Dysglycemia, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ambady Ramachandran, MD, PhD, DSc (04422353730, research@ardiabetes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of central adiposity (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.