Clinical trial NCT00610376: Jerusalem Handwashing Study
Official title: A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Illness Absenteeism
Handwashing Behavior
Keywords: Handwashing
Randomized controlled trial
Cluster randomization
Community intervention trial
Disease prevention
Pediatric communicable disease
Preschool
Illness absenteeism
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
name: Hadassah Medical Organization
name: Israel National Institute for Health Policy and Health Services Research
name: Ministry of Education, Israel
name: Municipality of Jerusalem, Israel
First posted: 2008-02-08
Enrollment: 1029
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.

Detailed description: Please see citations of published reports.

Eligibility criteria: Inclusion Criteria:

* Preschool teachers of 3- and 4-year-old children in the state-run public system of the Jerusalem region, who were recommended by their supervisors as being likely to comply with the protocol.

Exclusion Criteria:

* Exposure to project during testing phase (N=1 preschool), preschool which included new Ethiopian immigrants who were unlikely to have phones or speak Hebrew (N=1 preschool)
* Project staff knew teachers personally and thought they would not comply with protocol (N=2 teachers).

Primary outcomes:
measure: Illness absenteeism
timeFrame: Each school day during study period
Secondary outcomes:
measure: Handwashing behavior
timeFrame: Observational visits in classrooms (3-4)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University
Study officials:
affiliation: Hebrew University (at time of study)
name: Laura J Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: David M Zucker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: Orly Manor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Hebrew Univeristy Hospital
name: Dan Engelhard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen L, Manor O, Engelhard D, Brody D, Rosen B, Peleg H, Meir M, Zucker D. Can a handwashing intervention make a difference? Results from a randomized controlled trial in Jerusalem preschools. Prev Med. 2006 Jan;42(1):27-32. doi: 10.1016/j.ypmed.2005.09.012. Epub 2005 Nov 21.
citation: Rosen L, Manor O, Engelhard D, Zucker D. Design of the Jerusalem Handwashing Study: meeting the challenges of a preschool-based public health intervention trial. Clin Trials. 2006;3(4):376-84. doi: 10.1177/1740774506070690.
citation: Rosen L, Manor O, Engelhard D, Zucker D. In defense of the randomized controlled trial for health promotion research. Am J Public Health. 2006 Jul;96(7):1181-6. doi: 10.2105/AJPH.2004.061713. Epub 2006 May 30.