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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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

2815

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600008
        • Rekruttering
        • India Diabetes Research Foundation
        • Ta kontakt med:
          • Ambady Ramachandran, MD, PhD, DSc
        • Hovedetterforsker:
          • Ambady Ramachandran, MD, PhD, DSc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Annen
  • Tidsperspektiver: Tverrsnitt

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of central adiposity
Tidsramme: baseline
Among adolescent children in 2019 in comparison with 2006 data
baseline
Prevalence of dysglycemia
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of dyslipidemia
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of hypertension
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of insulin resistance
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of overweight
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of obesity
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Changes in diet habit
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Changes in duration of physical activity
Tidsramme: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2019

Primær fullføring (Forventet)

31. august 2021

Studiet fullført (Forventet)

31. desember 2021

Datoer for studieregistrering

Først innsendt

29. juni 2019

Først innsendt som oppfylte QC-kriteriene

9. juli 2019

Først lagt ut (Faktiske)

11. juli 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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