| CTRI Number |
CTRI/2025/05/086672 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Encouraging tribal adolescents to adapt a healthy lifestyle with the formation of a school health club |
|
Scientific Title of Study
|
Health and Nutrition Education for Tribal adolescents through School Health Club: An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini Shashank Kanade |
| Designation |
Research Scholar |
| Affiliation |
SNDT Womens University Juhu Mumbai |
| Address |
Food Science and Nutrition Department First Floor SNDT Womens University Juhu Tara Road Daulat Nagar Santacruz West Mumbai Maharashtra 400049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9820744050 |
| Fax |
|
| Email |
kanade.ashwini77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Leena Rajan Raje |
| Designation |
PhD Guide |
| Affiliation |
SNDT University |
| Address |
Plot No: A 223, 2nd Floor, Miraj Corporate Park, Road No. 16 V, Nehru Nagar, Wagle Industrial Estate, Thane West.
Thane
MAHARASHTRA
400604
India |
| Phone |
9920385557 |
| Fax |
|
| Email |
rajeleena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Leena Rajan Raje |
| Designation |
Research Guide |
| Affiliation |
SNDT Womens University Juhu Mumbai |
| Address |
Food Science and Nutrition Department First Floor SNDT Womens University Juhu Tara Road Daulat Nagar Santacruz West Mumbai Maharashtra 400049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9920385557 |
| Fax |
|
| Email |
rajeleena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goandevi Ashram School, Khadawali.Maharashtra. |
| Knowledge Resource Centre Juhu Branch SNDT Womens University Sir Vithaldas Vidyavihar Juhu Tara Road Santacruz West Mumbai 400049.Country India. |
|
|
Primary Sponsor
|
| Name |
Ashwini Shashank Kanade |
| Address |
SNDT Womens University Juhu Tara Road Daulat Nagar Santacruz West. Mumbai, Maharashtra 400049 |
| Type of Sponsor |
Other [Self Funded study ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashwini Shashank Kanade |
Goandevi Ashram Shala |
Ground Floor, Room No 2,Khadawali Station Road, Khadawali, Kalyan
Thane, Maharashtra
PIN Code: 421301
Thane
MAHARASHTRA |
9322882600
kanade.ashwini77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society |
Approved |
| Study Site Letter Khadawali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
School Health Club |
Students from the Ashram school will be identified and invited to be a part of the School Health Club. Educational sessions will be conducted with the participants for 6 months and they will be encouraged to disseminate the health education further after 6 months to the other school children. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Students in the age group of 10-15 years will be included in the study
2. Students who reside in the Ashram of the school and consume all the meals in the school will
be included in the study |
|
| ExclusionCriteria |
| Details |
1. Students below the age of 10 years and above the age of 16 years will be excluded from the
study.
2. Students undergoing treatment for any chronic medical conditions will be excluded from the
study.
3. Students not willing to be a part of and have refused the assent and parents who have refused
consent will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the KAP among the study samples.
2. Improved Hygiene at the school.
3. Changes in the Serum Hemoglobin of the study samples |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved Hygiene practices among the school children.
Improved nutritional intake among the school children |
6 months |
|
|
Target Sample Size
|
Total Sample Size="366"
Sample Size from India="366"
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)
|
10/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To develop an intervention program inclusive of the 3 modules (Health, Nutrition, and Physical Activity) for the selected schools. 1. To establish health club in the selected schools and provide leadership training to teachers and students to implement the intervention program.
2. To record the anthropometry of the study sample.
3. Surveillance of Knowledge Attitude and Practice (KAP) regarding hygiene, nutrition, and Physical Activity (PA) of the study sample.
4. Nutrition status of selected students using direct and indirect tools
5. To calculate the nutritive value of the meals (Breakfast, Lunch, and Dinner) served in these schools and educate the management on nutritional diversity for health enhancement of the school students.
6. To implement the intervention program for six months and assess its effectiveness in terms of anthropometry and KAP of the study sample. |