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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01043809
Other study ID # CDC-NCEZID-5281
Secondary ID
Status Completed
Phase N/A
First received January 6, 2010
Last updated February 5, 2013
Start date January 2008
Est. completion date June 2008

Study information

Verified date February 2013
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.


Recruitment information / eligibility

Status Completed
Enrollment 15000
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 19 students per first grade class

- Piped water tap available to every 30 first grade students for handwashing

Exclusion Criteria:

- Compulsory handwashing or distribution of hand wipes before school lunch

- Commercial handwashing promotion at school during previous 5 years

Study Design

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


Intervention

Behavioral:
Procter & Gamble school-based handwashing promotion program
Handwashing promotion lesson and materials targeting first grade students
expanded school-based handwashing promotion
Procter & Gamble's standard school-based handwashing promotion education and materials targeting first grade students, plus a program enhancement. In China, enhancement consists of a supply of soap for school sinks. In Pakistan, enhancement consists of soap for school sinks, plus enlistment of a peer hygiene champion in each first grade class. In the Philippines, enhancement consists of enlistment of a peer hygiene champion in each first grade class.

Locations

Country Name City State
China Zhejiang Province CDC Hangzhou Zhejiang
Pakistan Project HOPE Karachi Sindh
Philippines FETPAFI Manila

Sponsors (6)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention Centers for Disease Control and Prevention, China, Field Epidemiology Training Program Alumni Foundation, Inc., Procter and Gamble, Project HOPE, Zhejiang Provincial Center for Disease Control and Prevention

Countries where clinical trial is conducted

China,  Pakistan,  Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary student school absences / 100 student-weeks of observation one semester No
Secondary Student absences due to respiratory illness / 100 student-weeks of observation one semester No
Secondary student absences due to infectious syndromes / 100 student-weeks of observation one semester No
Secondary longitudinal prevalence of infectious syndromes among students' family members one semester No
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