- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413485
Canadian Beach Cohort Study
Canadian Beach Cohort Study: Prospective Study to Assess the Burden of Recreational Water Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Swimming and other beach water activities are increasingly popular outdoor leisure activities among Canadians. However, these activities increase the risk of acquiring acute gastrointestinal illness (AGI) and other acute illnesses among beachgoers. Recreational water illness (RWI) has a significant health burden, with young children having the highest rates of illness. These illnesses result in substantial costs to society due to healthcare costs and lost productivity. Data are lacking in Canada on the risk and burden of RWI, and beachgoers may lack awareness and understanding of RWI risks and how to prevent them. There is a critical need to conduct timely research on the burden of RWI in Canada to inform recreational water quality guidelines and public health risk management.
The purpose of this study is to identify the burden of RWI among Canadian beachgoers and to develop recommendations for improving recreational water quality risk management, communication, and pollution source prevention. The objectives are to:
- Measure the risk and burden of five different RWI outcomes (AGI, respiratory, eye, ear, and skin infections) in beachgoers that engage in different levels of water and sand contact;
- Identify differences in RWI risks by beachgoer gender, age, and beach location;
- Determine relationships between fecal indicator bacteria, environmental parameters, host-specific biomarkers, and the risk of AGI among beachgoers; and
- Understand beachgoer risk perceptions and behaviours related to recreational water quality and socio-political issues that may impact RWI risks among beachgoers.
The study will use a mixed-methods approach, consisting of a prospective cohort study (Objectives 1-3) with embedded qualitative research (Objective 4). The cohort study will involve enrolling participants at public beaches, ascertaining their water and sand contact exposure status, then following-up to determine the incidence of acute RWI outcomes. The investigators will combine beachgoer exposure data with routinely collected secondary data on environmental parameters and E. coli levels in beach water. The investigators will also test for enterococci as another fecal indicator using rapid molecular methods and will conduct microbial source tracking to determine the contribution of different sources of fecal contamination (e.g., human, avian) to AGI. The study will take place at eight targeted freshwater and marine beach sites in British Columbia, Manitoba, and Ontario. The qualitative research will consist of focus groups to determine beachgoer risk perceptions and behaviours toward recreational water quality and key informant interviews with stakeholders to provide additional socio-political insights and context.
The long-term goal of this study is to reduce the burden of RWI in Canada, contributing to improved public health. The study will be led by an experienced, diverse, and multi-disciplinary research team, including engagement with public health and environmental authorities. Activities will be guided by a stakeholder steering group consisting of key knowledge-users (KUs). This integrated KT approach will help to ensure that the results are relevant and useful to KUs, facilitating their direct uptake to influence recreational water quality policies and practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ian Young
- Phone Number: 557614 416-979-5000
- Email: iyoung@torontomu.ca
Study Contact Backup
- Name: Jodan Tustin
- Phone Number: 553021 4169795000
- Email: jtustin@torontomu.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Recruiting
- English Bay Beach and Kitsilano Beach
-
Contact:
- Iris Chan
- Email: iris.chan@vch.ca
-
Contact:
- Michael Schwandt
- Phone Number: 866-884-0888
- Email: michael.schwandt@vch.ca
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Recruiting
- Grand Beach
-
Contact:
- Dylan Lyng
- Phone Number: 431-337-7880
- Email: Dylan.lyng@gov.mb.ca
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Not yet recruiting
- Birch Cove Beach
-
Contact:
- Elizabeth Montgomery
- Phone Number: 902.943.1954
- Email: Elizabeth.Montgomery@halifax.ca
-
-
Ontario
-
Fort Erie, Ontario, Canada
- Not yet recruiting
- Bay Beach and Nickel Beach
-
Contact:
- Brandon Krupa
- Phone Number: 888-505-6074
- Email: brandon.krupa@niagararegion.ca
-
Toronto, Ontario, Canada
- Completed
- Sunnyside and Marie Curtis Park East beaches
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ability to provide informed consent for the study and complete the surveys in English or French
- Home address in Canada or the U.S.
- Must not have participated in the study in the past 21 days
Exclusion Criteria:
- Not a Canadian or U.S. resident.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Beachgoers
Beachgoing families and households to one or more Canadian beaches during the summers of 2023 to 2026.
|
We will examine a graded classification of this exposure based on individuals' minimum level of water contact: 1) no water contact; 2) minimal contact; 3) body immersion; 4) swallowed water.
Minimal contact is defined as water contact that does not result in body immersion (e.g., wading below one's waist, boating, fishing).
Body immersion is defined as entering the water above one's waist (e.g., swimming, surfing, snorkelling), and swallowing water as ingestion of any amount of water.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acutre gastrointestinal illness (AGI)
Time Frame: Within 7 days of beach visit/water contact
|
Self-reported AGI in the 7-day period following beach water contact.
Defined as one or more of: (a) diarrhea (≥3 loose stools in 24 hrs); (b) vomiting; (c) nausea with stomach cramps; or (d) nausea or stomach cramps that interfere with regular daily activities (e.g., missed work or school).
|
Within 7 days of beach visit/water contact
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute respiratory illness
Time Frame: Within 7 days of beach visit/water contact
|
Self-reported fever with sore throat, fever with nasal congestion, or cough with phlegm
|
Within 7 days of beach visit/water contact
|
Skin infection
Time Frame: Within 7 days of beach visit/water contact
|
Self-reported rash or itchy skin
|
Within 7 days of beach visit/water contact
|
Ear infection or earache
Time Frame: Within 7 days of beach visit/water contact
|
Self-reported ear infection or earache
|
Within 7 days of beach visit/water contact
|
Eye infection or irritation
Time Frame: Within 7 days of beach visit/water contact
|
Self-reported eye infection or irritation
|
Within 7 days of beach visit/water contact
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian Young, School of Occupational and Public Health, Toronto Metropolitan University
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
- TorontoMetropolitan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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