NCT06579170

Brief Summary

Swimming and other recreational water activities at public beaches are increasingly popular leisure activities among Canadians. However, harmful algal blooms caused by blue-green algae (i.e., cyanobacteria) have also been increasing reported at Canadian public beaches in recent years. These algal blooms can cause various acute illnesses among recreational water users through ingestion, inhalation of aerosols, or skin contact with contaminated water. In addition, blue-green algae blooms and their toxins can cause illnesses in pets and wildlife. Currently, baseline data are lacking on the risk of recreational water illness from exposure to blue-green algae blooms in Canada. This study will identify the burden of recreational water illness among recreational water users at four targeted beach sites in Ontario, Manitoba and Nova Scotia, over a two-year period. A prospective cohort study design will be used. The investigators will determine the risk of acquiring acute illness outcomes in recreational water users, as well as their pet dogs, that engage in different levels of water contact at beaches at risk of blue-green algae blooms. The investigators will examine differences in illness risks by gender, age, and location. Relationships between cyanobacterial cell counts, toxin levels, and environmental conditions with the risk of acute illness among participants will be determined. Overall, results will provide important data on the risk of recreational water illness from exposure to blue-green algae and their toxins in Canadian beach settings.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

August 28, 2024

Last Update Submit

September 2, 2025

Conditions

Keywords

Cohort studyHarmful algal bloomsRecreational water contactCyanobacteriaOne Health

Outcome Measures

Primary Outcomes (1)

  • Incidence of gastrointestinal illness among participants

    Gastrointestinal illness is 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 3 days of beach visit

Secondary Outcomes (4)

  • Incidence of respiratory illness among participants

    Within 3 days of beach visit

  • Incidence of eye infections among participants

    Within 3 days of beach visit

  • Incidence of skin infections among participants

    Within 3 days of beach visit

  • Incidence of generalized symptoms among participants

    Within 3 days of beach visit

Other Outcomes (1)

  • Incidence of illness severity measures among participants

    Within 3 days of beach visit

Study Arms (1)

Recreational water users

Recreational water users of any age and their pet dogs present at the beaches and waterfronts in this study during recruitment days.

Behavioral: Cyanobacteria exposure during water contact

Interventions

Cyanobacteria levels in beach water among participants who report water contact in the beach survey

Recreational water users

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recreational water users of any age, and any pet dogs also present at the beaches/waterfront areas, during the study recruitment days.

You may qualify if:

  • ability to provide informed consent
  • ability to complete the surveys in English or French
  • must not have participated in the study in the past 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Grand Beach

Winnipeg, Manitoba, R0E 0T0, Canada

Location

Shubenacadie Canal

Halifax, Nova Scotia, B2X 2W5, Canada

Location

Kinsmen beach

Port Perry, Ontario, L9L 1R2, Canada

Location

Colchester Beach

Windsor, Ontario, N0R 1G0, Canada

Location

Related Publications (1)

  • Young I, Sanchez JJ, Sekerciouglu F, Desta BN, Holeton C, Lyng D, Peczulis V, Renwick S, Brooks T, Tustin J. Burden of recreational water illness due to exposure to cyanobacteria and their toxins in freshwater beaches in Canada: protocol of a prospective cohort study. BMJ Open. 2024 Jun 12;14(6):e085406. doi: 10.1136/bmjopen-2024-085406.

    PMID: 38866574BACKGROUND

MeSH Terms

Conditions

GastroenteritisGastrointestinal DiseasesEye InfectionsCellulitisRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfectionsEye DiseasesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

June 1, 2024

Primary Completion

September 15, 2025

Study Completion

March 31, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

An anonymized dataset will be shared publicly after results are published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Study protocol is already published. Code and dataset will be shared after study publication of results.
More information

Locations