Communicable DiseasesPhase 4NCT00140335
Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools
A Phase 4 study testing handwashing in people with Communicable Diseases, run by Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Communicable Diseases
- What is being tested?
- handwashing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2004to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- school has running water
Who cannot join
- school has not previously received commercial handwashing promotion program
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences.
Read the detailed description
Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the developing world. Reduced rates of these diseases have been measured during intensive, home-based handwashing interventions. We evaluated a school-based handwashing program for 1st grade students to determine whether a more scalable intervention could also reduce illness rates, and impact hygiene knowledge and attitudes.
Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of the following groups: a) control; b) standard intervention, which included a handwashing program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded intervention, which included the handwashing program, soap for school sinks and 1 peer hygiene monitor per class. Teachers collected illness symptom information from students weekly and recorded student absences daily between January and April, 2005. Mean illness and absence rates were calculated for each school. Students were given a knowledge, attitudes, and practices questionnaire before the intervention and again 5 months later.
- Conditions
- Communicable Diseases
- Being tested
- handwashing
- Keywords
- handwashing, communicable diseases, health education
- Medical subject headings
- Communicable Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handwashingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
student illness rates
student absence rates
Secondary outcomes (4)
teacher illness rate
changes in student hygiene knowledge
changes in student hygiene attitudes
changes in school water use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Procter and Gamble, Centers for Disease Control and Prevention, China, Fujian Province CDC
- Investigators
- Anna B Bowen, MD, MPH, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140335
- Sponsor's protocol ID
- CDC-NCID-4427
- Status last verified
- Mar 2010
- First submitted
- 30 Aug 2005
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools
- ClinicalTrials.gov ID
- NCT00140335
- Acronym / sponsor ID
- CDC-NCID-4427
- Conditions
- Communicable Diseases
- Keywords
- handwashing, communicable diseases, health education
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Procter and Gamble, Centers for Disease Control and Prevention, China, Fujian Province CDC
- Study start
- Dec 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences.
Detailed description
Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the developing world. Reduced rates of these diseases have been measured during intensive, home-based handwashing interventions. We evaluated a school-based handwashing program for 1st grade students to determine whether a more scalable intervention could also reduce illness rates, and impact hygiene knowledge and attitudes.
Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of the following groups: a) control; b) standard intervention, which included a handwashing program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded intervention, which included the handwashing program, soap for school sinks and 1 peer hygiene monitor per class. Teachers collected illness symptom information from students weekly and recorded student absences daily between January and April, 2005. Mean illness and absence rates were calculated for each school. Students were given a knowledge, attitudes, and practices questionnaire before the intervention and again 5 months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- school has running water
Key exclusion criteria (1 listed)
- school has not previously received commercial handwashing promotion program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handwashing | Behavioural | – |
Primary outcome
student illness rates
student absence rates
4 secondary outcomes
teacher illness rate
changes in student hygiene knowledge
changes in student hygiene attitudes
changes in school water use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna B Bowen, MD, MPH study director
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing handwashing in people with Communicable Diseases, run by Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
student illness rates. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.