- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610376
Jerusalem Handwashing Study (JHS)
September 21, 2015 updated by: Hebrew University of Jerusalem
A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools
The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Please see citations of published reports.
Study Type
Interventional
Enrollment (Actual)
1029
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel, 91120
- Hebrew University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1A
Preschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children.
Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program.
The children in this arm received the home intervention component.
|
This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
The home component was intended to reinforce handwashing practices through education in the home.
It consisted of a video, a magnet, and a card.
|
|
Active Comparator: 2
This group did not receive any special treatment during the study, but did receive the intervention at the close of the study
|
This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
|
|
Experimental: 1B
Preschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children.
Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program.
The children in this arm received the home control component.
|
This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
The home component was intended to reinforce handwashing practices through education in the home.
It consisted of a video, a magnet, and a card.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Illness absenteeism
Time Frame: Each school day during study period
|
Each school day during study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Handwashing behavior
Time Frame: Observational visits in classrooms (3-4)
|
Observational visits in classrooms (3-4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura J Rosen, PhD, Hebrew University (at time of study)
- Principal Investigator: David M Zucker, PhD, Hebrew University
- Principal Investigator: Orly Manor, PhD, Hebrew University
- Principal Investigator: Dan Engelhard, MD, Hadassah Hebrew Univeristy Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Clin Trials. 2007;4(4):475.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2000
Primary Completion (Actual)
December 1, 2001
Study Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
January 27, 2008
First Submitted That Met QC Criteria
February 7, 2008
First Posted (Estimate)
February 8, 2008
Study Record Updates
Last Update Posted (Estimate)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 21, 2015
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JHS1
- NIHP Doctoral Stipend [m-2-02]
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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