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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00610376
Other study ID # JHS1
Secondary ID NIHP Doctoral St
Status Completed
Phase Phase 3
First received January 27, 2008
Last updated September 21, 2015
Start date September 2000
Est. completion date December 2001

Study information

Verified date January 2008
Source Hebrew University of Jerusalem
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Description:

Please see citations of published reports.


Recruitment information / eligibility

Status Completed
Enrollment 1029
Est. completion date December 2001
Est. primary completion date December 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 4 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Preschool handwashing intervention program
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.
Home component intervention
The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.

Locations

Country Name City State
Israel Hebrew University Jerusalem

Sponsors (6)

Lead Sponsor Collaborator
Hebrew University of Jerusalem Hadassah Medical Organization, Israel National Institute for Health Policy and Health Services Research, Ministry of Education, Israel, Ministry of Health, Israel, Municipality of Jerusalem, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Epub 2005 Nov 21. — View 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. Erratum in: Clin Trials. 2007;4(4):475. — View 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. Epub 2006 May 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Illness absenteeism Each school day during study period No
Secondary Handwashing behavior Observational visits in classrooms (3-4) No