Jerusalem Handwashing Study

NCT ID: NCT00610376

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1029 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2001-12-31

Brief Summary

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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

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Please see citations of published reports.

Conditions

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Illness Absenteeism Handwashing Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Preschool handwashing intervention program

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.

2

This group did not receive any special treatment during the study, but did receive the intervention at the close of the study

Group Type ACTIVE_COMPARATOR

Preschool handwashing intervention program

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Preschool handwashing intervention program

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Israel National Institute for Health Policy and Health Services Research

OTHER_GOV

Sponsor Role collaborator

Ministry of Education, Israel

OTHER_GOV

Sponsor Role collaborator

Municipality of Jerusalem, Israel

UNKNOWN

Sponsor Role collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Laura J Rosen, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University (at time of study)

David M Zucker, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Orly Manor, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Dan Engelhard, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Hebrew Univeristy Hospital

Locations

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Hebrew University

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 16300823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17060212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16735622 (View on PubMed)

Other Identifiers

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NIHP Doctoral Stipend [m-2-02]

Identifier Type: -

Identifier Source: secondary_id

JHS1

Identifier Type: -

Identifier Source: org_study_id

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