- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04015726
Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, Índia, 600008
- Recrutamento
- India Diabetes Research Foundation
-
Contato:
- Ambady Ramachandran, MD, PhD, DSc
-
Investigador principal:
- Ambady Ramachandran, MD, PhD, DSc
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Transversal
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of central adiposity
Prazo: baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
|
Prevalence of dysglycemia
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of dyslipidemia
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of hypertension
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of insulin resistance
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of overweight
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of obesity
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in diet habit
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in duration of physical activity
Prazo: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IDRFARH012
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .