Children's Health, Respiratory Inflammation and Short-term Air Pollution (CHERISH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will recruit a total of 330 children from 10 primary schools split into two groups: "higher pollution" and "lower pollution" schools. The team shall invite children in years 3 to 6 to take part in the study and consent will be provided by parents following information sheets sent home in school bags and parent evening presentations.
After the team have received written permission from parents. The study team will visit the school on two days. On the first day the study team will perform lung health assessment in a dedicated classroom. The assessment will involve, measuring children's height and weight, a breathing test (photo and a snot sample collected by squirting a small bit of saline water up one nostril and catching the snot in a cup.
Children will then take part in a PE lesson or a sedentary science lesson in a random order in their school playground while wearing activity monitors - like a Fitbit- to track their physical activity. The session is designed to be just like a typical outdoor science or PE lesson and will be exactly the same at all schools. Air pollution levels in the playground will be monitored during this time.
Once the PE lesson has finished the children will perform the same health assessment immediately after the lesson and again on a second day. The team shall compare the change in these scores between higher and lower pollution schools. The breathing tests will tell us if the has been any change in lung health and the snot samples will tell us about the pollution the children have breathed and how their bodies try to fight it. Participating will take about 4 hours total.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James Scales, PhD
- Phone Number: +447533897264
- Email: j.scales@qmul.ac.uk
Study Contact Backup
- Name: Abigail Whitehouse, MD,PhD
- Email: a.whitehouse@qmul.ac.uk
Study Locations
-
-
-
London, United Kingdom, E1 2AB
- Recruiting
- Faculty of Medicine and Dentistry
-
Contact:
- James Scales
- Phone Number: 07533897264
- Email: j.scales@qmul.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Attending schools in Central and East London that have been recruited to the study
Exclusion Criteria:
- Not able to engage with PE lessons on safety grounds, reported by their parents.
- Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical activity
PE Lesson
|
CHildren have a 90 minute PE lesson outdoors
|
|
Active Comparator: Sedenary
Science lesson
|
children have a 90 minute science lesson outdoors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Airway resistance" measured by Oscillometry at R5
Time Frame: Pre-24 hour post exposure
|
measured as oscillometery R5
|
Pre-24 hour post exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Small airway resistance" measured by Oscillometry at R5-20
Time Frame: pre- 24 hour post exposure
|
Measured by oscillometry R5-20
|
pre- 24 hour post exposure
|
|
Immune responses as measured by Il6 in nasal lavage
Time Frame: pre-24 hour post exposure
|
Immune response as measured by Il6 in nasal lavage
|
pre-24 hour post exposure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Scales, PhD, Queen Mary University London
- Principal Investigator: Abigail Whitehouse, PhD, MD, QMUL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QME25.1220
- G-002887 (Other Grant/Funding Number: Barts Charity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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