Effect of Health Education on Promoting Influenza Vaccination Health Literacy
1 other identifier
interventional
3,036
1 country
1
Brief Summary
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China. Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months. Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFebruary 21, 2024
February 1, 2024
10 months
September 8, 2023
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
influenza vaccination rate
he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.
Within 20 weeks from enrollment
Secondary Outcomes (4)
influenza vaccination health literacy level
Within 20 weeks from enrollment
influenza incidence
Within 20 weeks from enrollment
influenza vaccine protection rate
Within 20 weeks from enrollment
influenza-like illness incidence
Within 20 weeks from enrollment
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months.
Control
NO INTERVENTIONThe control group will continue with their routine school health education for 5 months.
Interventions
The intervention group will receive a health education intervention focused on influenza vaccination literacy, while the control group will continue with their standard school health education without any additional intervention. An influenza vaccination health education including topics such as the importance of influenza vaccination, benefits of vaccination, and vaccination methods, will be developed and reviewed by an expert group. The package for the intervention group will include educational activities, distribution of promotional materials, vaccination services, and distribution of vaccination souvenirs.
Eligibility Criteria
You may qualify if:
- Primary school students within the age range of 7-12 years.
- Students and their parents who voluntarily agree to participate in the study and provide signed informed consent.
- Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period.
You may not qualify if:
- Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study.
- Unwilling to participate in the project.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongguang Center for Disease Control and Prevention
Dongzhoucun, Guangdong, 510000, China
Related Publications (2)
Chen J, Xie W, Huang X, Huang A, Lu T, Zhang R, Xiao J, He S, Wang J, Xu L. Impact of multifaceted health education on influenza vaccination health literacy in primary school students: a cluster randomized controlled trial. BMC Med. 2025 Jun 4;23(1):333. doi: 10.1186/s12916-025-04156-1.
PMID: 40468328DERIVEDXie W, Xiao J, Chen J, Huang H, Huang X, He S, Xu L. Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol. BMJ Open. 2024 Apr 12;14(4):e080115. doi: 10.1136/bmjopen-2023-080115.
PMID: 38609315DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Xu, PhD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes Assessor will not know the intervention status of the participants.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 21, 2023
Study Start
September 11, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share