- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04015726
Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600008
- Reclutamento
- India Diabetes Research Foundation
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Contatto:
- Ambady Ramachandran, MD, PhD, DSc
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Investigatore principale:
- Ambady Ramachandran, MD, PhD, DSc
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Altro
- Prospettive temporali: Trasversale
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prevalence of central adiposity
Lasso di tempo: baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
|
Prevalence of dysglycemia
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of dyslipidemia
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of hypertension
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of insulin resistance
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prevalence of overweight
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of obesity
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in diet habit
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in duration of physical activity
Lasso di tempo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IDRFARH012
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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