| CTRI Number |
CTRI/2017/06/008814 [Registered on: 12/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the effectiveness of child to parent communication on food hygiene. |
|
Scientific Title of Study
|
A quasi experimental study to evaluate the effectiveness of child to parent communication using information package on food hygiene in Govt. Sr. Sec. School of Dhanas and Daddu Majra Colony , UT, Chandigarh, (2016-17) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam Yangchen Bhutia |
| Designation |
Student |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh,160012,India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9646419628 |
| Fax |
00911722744401 |
| Email |
sonamyangchen2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
Lecturer |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER,Chandigarh,
160012
INDIA
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
00911722744401 |
| Email |
sushmadr_saini@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manmeet Kaur |
| Designation |
Additional Professor of Health Promotion |
| Affiliation |
PGIMER, Chandigarh |
| Address |
School of Public Health, PGIMER,
Chandigarh
1620012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815071863 |
| Fax |
00911722744401 |
| Email |
mini.manmeet@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sonam Yangchen Bhutia |
| Address |
National Institute of Nursing Education , PGIMER, Chandigarh, 160012
INDIA
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr. Manmeet Kaur |
Dr. Manmeet Kaur
Additional Professor of Health Promotion
School of Public Health, PGIMER, Chandigarh, India, 1620012
mini.manmeet@gmail.com
Phone no: 9815071863
|
| Dr. Sushma Kumari Saini |
Dr. Sushma Kumari Saini
Lecturer
National Institute of Nursing Education, PGIMER, Chandigarh, 160012, India
Phne no- 9888038248
sushmadr_saini@yahoo.com
Phone no- 9888038248
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sonam Yangchen Bhutia |
 Govt. Senior Secondary School of Dhanas and Daddu Majra Colony, Chandigarh |
 Standard VIIth school children, Govt. Senior Secondary School of Dhanas and Daddu Majra Colony, UT, Chandigarh
Chandigarh
CHANDIGARH |
9646419628
00911722744401
sonamyangchen2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY SCHOOL CHILDREN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Informational package on food hygiene |
Informational package on food hygiene via health talk was provided to the school children for 5 days using charts, pamphlets, flash cards, demonstration of hand washing |
| Comparator Agent |
Standard Education |
Standard Food Hygiene Practices |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Students of standard VII
2. Students studying in Govt. Senior Secondary School of Dhanas and Daddu Majra Colony, UT, Chandigarh
3. Ability to understand Hindi and English
4. Parent/ family members and the school children residing in Dhanas and Daddu Majra Colony.
5. Parent/ family members and the school children willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
 SCHOOL CHILDREN WITH PHYSICAL AND MENTAL DISABILITIES |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DISSEMINATION OF INFORMATION ON FOOD HYGIENE FROM SCHOOL CHILDREN TO PARENTS/ FAMILY MEMBERS |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KNOWLEDGE ON FOOD HYGIENE PRACTICES AMONG PARENTS/ FAMILY MEMBERS OF SCHOOL CHILDREN. |
2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Health education is a combination of learning experiences which helps individual group and the community to behave in a conducive manner leading to promotion of health, maintenance and restoration of health. Food borne disease is one of the health hazards in developing countries like India leading to high cases of mortality and morbidity.
This study is a quasi experimental study to evaluate the effectiveness of child to parent communication using informational package on food hygiene in Govt. Senior Secondary School of Dhanas and Daddu Majra Colony, UT, Chandigarh.
Null hypothesis: There is no significant difference on food hygiene of parents/ family members of the school children after the implementation of information package at the level of 0.05 significance.
Alternative hypothesis: There is significant improvement on food hygiene practices of parents/ family members of the school children after the implementation of information package at the level of 0.05 significance. |