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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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