| CTRI Number |
CTRI/2022/06/043280 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
09/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dietary behavior, physical activity and nutritional intake of school going adolescents |
|
Scientific Title of Study
|
Assessment of dietary behavior, physical activity and nutritional intake of school going adolescents aged 13 - 15 years.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanvi Virchand Maisheri |
| Designation |
Student - M. Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7506362097 |
| Fax |
|
| Email |
dhanviresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
900302531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanvi Virchand Maisheri |
| Designation |
Student - M. Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7506362097 |
| Fax |
|
| Email |
dhanviresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical
Nutrition and Dietetics |
|
|
Primary Sponsor
|
| Name |
Dhanvi Virchand Maisheri |
| Address |
Dr. BMN College of Home Science Matunga Department |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhanvi Maisheri |
Dr. BMN College of Home Science |
Department of
Postgraduate studies in
Clinical Nutrition and
Dietetics, Matunga
Mumbai 400019
Mumbai
MAHARASHTRA |
7506362097
dhanviresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No lifestyle or metabolic disorders |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
School Going children aged 13- 15 years
Studying in schools of Kalyan-Dombivali Municipal Corporation
Grade - 8th - 10th |
|
| ExclusionCriteria |
| Details |
Having any Lifestyle or metabolic disorder
Adolescents not Going to School |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of nutritional intake through the day, physical activity level and the sedentary behavior, anthropometric measurements of school going adolescents
|
At baseline |
|
|
Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM : To assess the dietary behavior, physical activity and nutritional intake of school going adolescents aged 13- 15 years in area of Kalyan-Dombivali Municipal Corporation
OBJECTIVES : - To assess the anthropometric status of middle adolescents (13- 15 years ) using height and weight measurements
- To evaluate dietary behavior of middle adolescents (13- 15 years ) using WHO Global School-based student health questionnaire
- To assess physical activity level of middle adolescents (13- 15 years ) using WHO Global School-based Student Health Questionnaire
- To evaluate dietary intakes of selected middle adolescents (13- 15 years) using 3 day food diary
- To compare daily dietary intakes of selected middle adolescents with intakes during school hours.
Materials and Methods
Study Design : Cross sectional Study Sample : School students belonging to middle adolescents age group ( age 13 - 15 years ) Sample Size: Data will be collected from 200 middle adolescents school students Inclusion criteria:
Exclusion criteria: Having any lifestyle and metabolic disorders
Hypothesis There is no association between Anthropometric Measurements and Dietary intake, Physical Activity in Middle Aged Adolescents
|