NCT00610376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,029

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2000

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

September 22, 2015

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

January 27, 2008

Last Update Submit

September 21, 2015

Conditions

Illness AbsenteeismHandwashing Behavior

Keywords

HandwashingRandomized controlled trialCluster randomizationCommunity intervention trialDisease preventionPediatric communicable diseasePreschoolIllness absenteeism

Outcome Measures

Primary Outcomes (1)

  • Illness absenteeism

    Each school day during study period

Secondary Outcomes (1)

  • Handwashing behavior

    Observational visits in classrooms (3-4)

Study Arms (3)

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 programBehavioral: Home component intervention

2

ACTIVE COMPARATOR

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

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 programBehavioral: Home component intervention

Interventions

Preschool handwashing intervention programBEHAVIORAL

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.

1A1B2
Home component interventionBEHAVIORAL

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

1A1B

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University

Jerusalem, 91120, Israel

Location

Related 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. doi: 10.1016/j.ypmed.2005.09.012. Epub 2005 Nov 21.

    PMID: 16300823BACKGROUND

  • 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.

    PMID: 17060212BACKGROUND

  • 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.

    PMID: 16735622BACKGROUND

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2008

First Posted

February 8, 2008

Study Start

September 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

September 22, 2015

Record last verified: 2008-01

Locations

IL(1)