Support Centre
24 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Hi Five - a school based intervention to reduce infections and improve hygiene and well-being among school children
DOI 10.1186/ISRCTN19287682
ClinicalTrials.gov identifier
EudraCT number
Public title Hi Five - a school based intervention to reduce infections and improve hygiene and well-being among school children
Scientific title Hi Five Ė a cluster-randomized controlled trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark
Acronym Hi Five
Serial number at source N/A
Study hypothesis 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 childrenís wellbeing.
Lay summary Lay summary under review 2
Ethics approval Danish Data Protection Agency, 1 October 2011, ref: 2011-54-1240
Study design Cluster-randomized controlled trial
Countries of recruitment Denmark
Disease/condition/study domain Hand hygiene, hand washing, infectious illness
Participants - inclusion criteria All pupils at participating schools enrolled in grade 0.-8
Participants - exclusion criteria 1. Schools not run by municipalities (private schools)
2. Schools for children with special needs
Anticipated start date 01/09/2011
Anticipated end date 30/06/2013
Status of trial Completed
Patient information material 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.
Target number of participants 7.527 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
Interventions 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.
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).
2. Frequency of absence episodes from school last week due to infectious illness (data from pupilsí 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 measure(s) 1. 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 pupilsí self-reported questionnaires)
3. Pupilsí use of the school toilettes (data from pupilsí self-reported questionnaires)
4. Toilet facilities and cleaning standard of the schools toilets (bacteria samples, observations and photographs of/from the school toilets)
5. Pupilsí well-being (data from pupilsí self-reported questionnaires)
6. Pupilsí norms of and attitudes towards hand washing (data from pupilsí self-reported questionnaires)
7. Pupilsí knowledge of bacteria and spread of infectious illness (data from pupilsí self-reported questionnaires)
8. Frequency of teacherís 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
Sources of funding Tryg Foundation (TrygFonden) (Denmark)
Trial website http://www.interventionsforskning.dk/hifive
Contact name Prof  Pernille  Due
  Address Øster Farimagsgade 5A
  City/town Copenhagen
  Zip/Postcode 1353
  Country Denmark
  Tel +45 65 50 77 77
  Fax +45 39 20 80 10
  Email pdu@sdu.dk
Sponsor Tryg Foundation (TrygFonden) (Denmark)
  Address Lyngby Hovedgade 4, Floor 2
  City/town Kgs. Lyngby
  Zip/Postcode DK- 2800
  Country Denmark
  Tel +45 26 08 00
  Email info@trygfonden.dk
  Sponsor website: http://www.trygfonden.dk/
Date applied 13/12/2012
Last edited 21/12/2012
Date ISRCTN assigned 21/12/2012
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.