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 |
| Protocol serial number | N/A |
| Sponsor | Tryg Foundation (TrygFonden) (Denmark) |
| Funder | Tryg Foundation (TrygFonden) (Denmark) |
- 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
Plain English summary of protocol
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
Contact information
Scientific
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
| Phone | +45 (0)65 50 77 77 |
|---|---|
| pdu@sdu.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster-randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Hi Five - a cluster-randomized controlled trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark |
| Study acronym | Hi Five |
| Study objectives | An 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 |
| Health condition(s) or problem(s) studied | Hand hygiene, hand washing, infectious illness |
| Intervention | The 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 type | Behavioural |
| Primary outcome measure(s) |
1. 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). |
| Key secondary outcome measure(s) |
1. Parents absence from work due to the pupils infectious illness (SMS registration) |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 7527 |
| Key inclusion criteria | All pupils at participating schools enrolled in grade 0.-8 |
| Key exclusion criteria | 1. Schools not run by municipalities (private schools) 2. Schools for children with special needs |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- Denmark
Study participating centre
1353
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | 17/12/2020 | Yes | No |
| Other publications | process evaluation | 01/06/2015 | 17/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/12/2020: Publication references added.
