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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.

Descripción general del estudio

Descripción detallada

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 de estudio

De observación

Inscripción (Anticipado)

2815

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600008
        • Reclutamiento
        • India Diabetes Research Foundation
        • Contacto:
          • Ambady Ramachandran, MD, PhD, DSc
        • Investigador principal:
          • Ambady Ramachandran, MD, PhD, DSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Otro
  • Perspectivas temporales: Transversal

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of central adiposity
Periodo de tiempo: baseline
Among adolescent children in 2019 in comparison with 2006 data
baseline
Prevalence of dysglycemia
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of dyslipidemia
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of hypertension
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of insulin resistance
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of overweight
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Prevalence of obesity
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Changes in diet habit
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline
Changes in duration of physical activity
Periodo de tiempo: Baseline
Among adolescent children in 2019 in comparison with 2006 data
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2019

Finalización primaria (Anticipado)

31 de agosto de 2021

Finalización del estudio (Anticipado)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

29 de junio de 2019

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2019

Publicado por primera vez (Actual)

11 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

22 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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