Hi Five - a school-based intervention to reduce infections and improve hygiene and well-being among school children

ISRCTN ISRCTN19287682
DOI https://doi.org/10.1186/ISRCTN19287682
Secondary identifying numbers N/A
Submission date
13/12/2012
Registration date
21/12/2012
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Illness is the most common reason for school absence. 86 percent of all Danish children have been absent from school because of illness during a school year. Two thirds of children’s illnesses are caused by infection. Hand washing with soap and water is the most important hygiene measure in preventing the spread of infection. The aim of this study is to find out whether hygiene education and extra cleaning can improve hand hygiene and reduce the spread of infections in Danish schools.

Who can participate?
Danish boys and girls enrolled in the participating schools.

What does the study involve?
43 schools were randomly allocated into one of three groups. 15 schools carried on as normal,14 schools received hand hygiene educational materials and encouraged daily hand washing before lunch, and 14 schools received hand hygiene education, encouraged daily hand washing before lunch, and increased the cleaning of the school toilets during the school day.

What are the possible benefits and risks of participating?
The possible benefits of participating for the pupils and teachers are fewer sick days due to infections and better well-being. There are no known risks to participants.

Where is the study run from?
National Institute of Public Health, University of Southern Denmark.

When is the study starting and how long is it expected to run for?
The study started in September 2011 and will run until June 2013.

Who is funding the study?
Tryg Foundation (TrygFonden), Denmark.

Who is the main contact?
Anette Johansen
ajo@niph.dk

Study website

Contact information

Prof Pernille Due
Scientific

Øster Farimagsgade 5A
Copenhagen
1353
Denmark

Phone +45 (0)65 50 77 77
Email pdu@sdu.dk

Study information

Study designCluster-randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Only available in Danish. The information includes information material to parents, teachers and schools. Please use the contact details below to request a patient information sheet.
Scientific titleHi Five - a cluster-randomized controlled trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark
Study acronymHi Five
Study hypothesisAn educational and cleaning intervention in Danish schools can improve hand hygiene and reduce the prevalence of infections by 20% among children in intervention schools compared to control schools, and positively influence the children's wellbeing.
Ethics approval(s)Danish Data Protection Agency, 01/10/2011, ref: 2011-54-1240
ConditionHand hygiene, hand washing, infectious illness
InterventionThe Hi Five intervention consists of three components:
1. Educational materials (5/6 lessons) tailored to three age groups: 0.-3. grade, 4.-6. grade and 7.-9. grade.
Subjects: 1. Introduction to microbes, 2. Spread of infections, 3. How to wash hands most effectively? 4. School toilets.
2. Daily hand washing before lunch
3. Extra cleaning of school toilets during the school day

Hi Five schools were randomized into either control or one of two intervention groups. 15 schools had no intervention (control),14 schools had education and daily hand washing before lunch and 14 schools had education, daily hand washing before lunch and extra cleaning of school toilets (in the school year 2012- 2013).

All pupils at the 28 intervention schools received the education course during the fall 2012.

Baseline data was collected December 2011 to April 2012. Follow-up data will be collected in December 2012 to April 2013. The effect of the intervention is measured on one class at each grade level at each school.
Intervention typeBehavioural
Primary outcome measure1. Frequency of absence episodes and the number of days absent due to infectious illness among pupils measured over five months (Dec. to April) at baseline and follow-up (SMS data form parents SMS registers of illness and infection).
2. Frequency of absence episodes from school last week due to infectious illness (data from pupils’ self-reported questionnaires).

Frequency of absence episodes and the number of days absent due to illness and infection will be analyzed at individual-, class- and school-level.
Secondary outcome measures1. Parents absence from work due to the pupils infectious illness (SMS registration)
2. Pupils hand washing behavior (before lunch, after toilet visit, use of soap etc.) (data from pupils' self-reported questionnaires)
3. Pupils' use of the school toilets (data from pupils' self-reported questionnaires)
4. Toilet facilities and cleaning standard of the schools toilets (bacteria samples, observations and photographs of/from the school toilets)
5. Pupils' well-being (data from pupils' self-reported questionnaires)
6. Pupils' norms of and attitudes towards hand washing (data from pupils' self-reported questionnaires)
7. Pupils' knowledge of bacteria and spread of infectious illness (data from pupils' self-reported questionnaires)
8. Frequency of teacher's absence episodes and the number of days due to infectious illness measured over five months at baseline and follow-up (from SMS registration by teachers of own illness and infection)
9. Health economic evaluation (parent, child, teacher, school information)

Analyses in the project will have a special focus on subgroup analyses especially age, gender and socioeconomic position
Overall study start date01/09/2011
Overall study end date30/06/2013

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants7.527 pupils (4,940 in the intervention group, 2,714 in the control group) at 28 intervention schools and 15 control schools from 20 municipalities cross nationally
Participant inclusion criteriaAll pupils at participating schools enrolled in grade 0.-8
Participant exclusion criteria1. Schools not run by municipalities (private schools)
2. Schools for children with special needs
Recruitment start date01/09/2011
Recruitment end date30/06/2013

Locations

Countries of recruitment

  • Denmark

Study participating centre

Øster Farimagsgade 5A
Copenhagen
1353
Denmark

Sponsor information

Tryg Foundation (TrygFonden) (Denmark)
Government

Lyngby Hovedgade 4, Floor 2
Kgs. Lyngby
DK- 2800
Denmark

Phone +45 (0)26 08 00
Email info@trygfonden.dk
Website http://www.trygfonden.dk/
ROR logo "ROR" https://ror.org/02rcazp29

Funders

Funder type

Government

Tryg Foundation (TrygFonden) (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications process evaluation 01/06/2015 17/12/2020 Yes No
Results article results 01/03/2015 17/12/2020 Yes No

Editorial Notes

17/12/2020: Publication references added.