| CTRI Number |
CTRI/2019/10/021671 [Registered on: 16/10/2019] Trial Registered Prospectively |
| Last Modified On: |
14/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Awareness presentation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An awareness campaign on indoor air pollution |
|
Scientific Title of Study
|
Understanding the impact of an awareness campaign on indoor air pollution targeted towards school children (7th to 9th) in the city of Pune |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRF/AR/19-20/03 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komalkirti Apte |
| Designation |
Head, Clinical trials division |
| Affiliation |
Chest Research Foundation |
| Address |
Room No. 18, Department of Research, Clinical Trials division, Chest Research Foundation, Survey No. 15, Marigold Premises, Kalyaninagar Pune
Pune MAHARASHTRA 411014 India |
| Phone |
|
| Fax |
|
| Email |
drkomalapte@crfindia.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Komalkirti Apte |
| Designation |
Head, Clinical trials division |
| Affiliation |
Chest Research Foundation |
| Address |
Room No. 18, Department of Research, Clinical Trials division, Chest Research Foundation, Survey No. 15, Marigold Premises, Kalyaninagar Pune
Pune MAHARASHTRA 411014 India |
| Phone |
|
| Fax |
|
| Email |
drkomalapte@crfindia.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Komalkirti Apte |
| Designation |
Head, Clinical trials division |
| Affiliation |
Chest Research Foundation |
| Address |
Room No. 18, Department of Research, Clinical Trials division, Chest Research Foundation, Survey No. 15, Marigold Premises, Kalyaninagar Pune
Pune MAHARASHTRA 411014 India |
| Phone |
|
| Fax |
|
| Email |
drkomalapte@crfindia.com |
|
|
Source of Monetary or Material Support
|
| Room No. 18, Department of Research, Clinical Trials division, Chest Research Foundation, Marigold Premises, Kalyaninagar, Pune 411014 |
|
|
Primary Sponsor
|
| Name |
Chest Research Foundation |
| Address |
Chest Research Foundation, Survey No. 15, Marigold Premises, Kalyaninagar, Pune 411014 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Komalkirti Apte |
Chest Research Foundation |
Room No. 18, Department of RFesearch, Clinical Trials Division, Chest Research Foundation, Survey Nuber 15, Marigold Premises, Kalyaninagar, Pune 411014 Pune MAHARASHTRA |
9623023295
drkomalapte@crfindia.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Chest Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School children of standards 7th, 8th and 9th. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awareness presentation |
A 30 slide powerpoint presentation will be made to all school children enrolled in 7th, 8th and 9th standard across schools of Pune city. |
| Comparator Agent |
Not applicable |
Single arm study |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All schoolchildren enrolled in classes 7th, 8th and 9th. |
|
| ExclusionCriteria |
| Details |
Students absent from school on day of activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in knowledge of indoor air pollution in school children |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A list of indoor air pollutants specific to the homes of school children (7th – 9th std) in the city of Pune. |
3 months |
Awareness in indoor air pollution amongst school children (7th – 9th std) through a presentation and intra and inter school fine arts competitions
|
2 hours |
|
|
Target Sample Size
|
Total Sample Size="7500" Sample Size from India="7500"
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)
|
24/10/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Indoor air pollution is responsible for 3.8 million deaths globally. According to the latest Global Burden of Disease data, in 2017, 12.4 lakh deaths in India were attributed to air pollution of which a third were due to indoor air pollution and half were in people under the age of 70 years. Children are very receptive to information received at school. They also tend to implement their new found knowledge at home. Hence, this project is being undertaken in schools. About 24 schools in Pune have taken part in a previous study similar to this, and by using random sampling techniques, your school has been selected. This study will be done across 25 schools in Pune. We wish to involve children studying in standards 7, 8 and 9 in this activity. The activity would be a series of puzzles for the children to solve before and after the intervention of a presentation which would attempt to increase their awareness on indoor air pollution and simple measures to curb it. All the students in your school would eligible to attend the presentation. The students of standard 7, 8 and 9 would have a puzzle paper before and after the presentation. The school would be encouraged to have an intra school competition in the form of plays, debates, paintings, posters or model making with indoor air pollution as its theme. If the school has intra school competitions, the school would be eligible for an interschool event scheduled for 24th Jan 2020. The students would also be given a souvenir booklet which would have a tear-off page. A third puzzle paper would be administered to these students between 27th and 31st Jan 2020. The study team will collect these as well as the tear-off page of the booklet. |