Jerusalem Handwashing Study - Tabular View

Tracking Information

First Received Date ^ICMJE

January 27, 2008

Last Updated Date

February 7, 2008

Start Date ^ICMJE

September 2000

Primary Completion Date

December 2001 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Illness absenteeism [ Time Frame: Each school day during study period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610376 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Handwashing behavior [ Time Frame: Observational visits in classrooms (3-4) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Jerusalem Handwashing Study

Official Title ^ICMJE

A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Illness Absenteeism
Handwashing Behavior

Intervention ^ICMJE

Behavioral: Preschool handwashing intervention program
Behavioral: Home component intervention

Study Arms / Comparison Groups

Experimental: 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.
No Intervention: This group did not receive any special treatment during the study, but did receive the intervention at the close of the study
Experimental: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1029

Completion Date

December 2001

Primary Completion Date

December 2001 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

3 Years to 4 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00610376

Responsible Party

Laura (Leah) Rosen, Hebrew University, Israel (at the time of conduct of the trial)

Study ID Numbers ^ICMJE

JHS1, NIHP Doctoral Stipend [m-2-02]

Study Sponsor ^ICMJE

Hebrew University of Jerusalem

Collaborators ^ICMJE

Ministry of Health, Israel
Hadassah Medical Organization
Israel National Institute for Health Policy and Health Services Research
Ministry of Education, Israel
Municipality of Jerusalem, Israel

Investigators ^ICMJE

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

Information Provided By

Hebrew University of Jerusalem

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP