- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486376
The Impact of WASH on Handwashing Practices Among School Children in Nigeria. (WASHEDUP)
The Impact of Teacher-led School Based Hygiene Campaign on Handwashing Practices and Prevention of Diarrhoea, Undernutrition and Pneumonia Among School Children in Nigeria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research project will be conducted as a school cluster-randomized study with 50 randomly selected low-cost private primary schools in the Lagos region. The expected number of schools included is 25 intervention and 25 control schools (schools that have not received the intervention but that are similar enough to the intervention schools to facilitate comparison). Quantitative data will be collected on the implementation and impact of the intervention, and qualitative data will be collected to explore teacher perceptions of best WASH practices. The intervention WASHED-UP (Water, Sanitation and Hygiene Education Against Diarrhoea, Undernutrition and Pneumonia) will be implemented as a 2-week health awareness campaign that will train children and teachers to deliver the program on hygiene promotion in schools. Intervention components include the presentation of interactive stories, games and songs, nutrition education, participatory food demonstration classes using food models, the use of animated characters representing occasions for handwashing with soap, practical and visual demonstrations to communicate the presence of germs and handwashing with soap removes them in comparison to only water, the use of daily diaries by students to record their handwashing behaviour and making a public commitment to handwashing with soap as a club. Digital surveys and implementation checklists will be used to collect the impact (survey) and implementation data, respectively and audio recordings of focus groups will be used to collect data related to stakeholder perceptions of the WASHED-UP program. For school absence, data are planned to be obtained from paper-based school records, including registers and sick-bay records. Approximately 3500 children will be recruited for data collection which will involve administering questions on socio-demographics, illness, reasons for school absence, disease history, sanitation behaviour at home and school and attendance at WASH clubs. At the end of the study all control schools will receive the intervention subsequently.
Data will be collected in three phases:
- Phase 1: February to March 2024 and will consist of a baseline survey.
- Phase 2: May to June 2024 and will consist of an implementation phase in the form of the intervention in the randomly selected 25 primary schools in Lagos.
- Phase 3: September to November 2024 and will consist of three months of follow-up post-implementation and comparison to control schools. Data will be collated using the Kobo Toolbox survey tool and analyzed with Statistical Package for Social Sciences (SPSS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lagos
-
Somolu, Lagos, Nigeria, 10004
- Kiddies Primary School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Schools are located in Lagos state
- Schools must have functional WASH facilities:
- Schools must have access to a water source
- Schools have school registers
Exclusion Criteria:
- School authorities refuse to participate
- Schools which have received WASH intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active comparator
Control Group: These will be schools where no intervention will be implemented, and routine practices are continued.
|
Intervention components include teacher training, stepdown training of teachers to children and distribution of IEC materials.
Other Names:
|
|
No Intervention: Control
No intervention group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sanitation and hygiene-related knowledge, attitudes, and practices of handwashing
Time Frame: 3 months
|
The incidence of diarrhoeal diseases and pneumonia among school children in primary schools in Lagos.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School absenteeism
Time Frame: 3 months
|
The difference in school absence and the occurrence of self-reported diarrhoea, and pneumonia symptoms between children who attended schools that participated in the WASHED-UP campaign versus children who attended schools that did not receive WASHED-UP?
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
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
- IRB-24-011
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
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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