Jerusalem Handwashing Study - Full Text View

Sponsor:	Hebrew University of Jerusalem
Collaborators:	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
Information provided by:	Hebrew University of Jerusalem
ClinicalTrials.gov Identifier:	NCT00610376

Purpose

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

Condition	Intervention	Phase
Illness Absenteeism Handwashing Behavior	Behavioral: Preschool handwashing intervention program Behavioral: Home component intervention	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools

Further study details as provided by Hebrew University of Jerusalem:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	1029
Study Start Date:	September 2000
Study Completion Date:	December 2001
Primary Completion Date:	December 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1A: 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.	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. 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.
2: No Intervention This group did not receive any special treatment during the study, but did receive the intervention at the close of the study	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.
1B: 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.	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. 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.

Detailed Description:

Please see citations of published reports.

Eligibility

Ages Eligible for Study:	3 Years to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610376

Locations

Israel
Hebrew University
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hebrew University of Jerusalem

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

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

More Information

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. 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. 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. Epub 2006 May 30.

Responsible Party:	Hebrew University, Israel (at the time of conduct of the trial) ( Laura (Leah) Rosen )
Study ID Numbers:	JHS1, NIHP Doctoral Stipend [m-2-02]
Study First Received:	January 27, 2008
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00610376 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Hebrew University of Jerusalem:

Handwashing
Randomized controlled trial
Cluster randomization
Community intervention trial

Disease prevention
Pediatric communicable disease
Preschool
Illness absenteeism

ClinicalTrials.gov processed this record on February 08, 2010