Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Tamil Nadu
-
Chennai、Tamil Nadu、インド、600008
- 募集
- India Diabetes Research Foundation
-
コンタクト:
- Ambady Ramachandran, MD, PhD, DSc
-
主任研究者:
- Ambady Ramachandran, MD, PhD, DSc
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:他の
- 時間の展望:断面図
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of central adiposity
時間枠:baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
|
Prevalence of dysglycemia
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of dyslipidemia
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of hypertension
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of insulin resistance
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of overweight
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Prevalence of obesity
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in diet habit
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
|
Changes in duration of physical activity
時間枠:Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
協力者と研究者
捜査官
- 主任研究者:Ambady Ramachandran, MD, PhD, DSc、Senior Research Officer
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。