Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000048088
Ethics application status
Approved
Date submitted
10/12/2009
Date registered
18/01/2010
Date last updated
18/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of educational DVD versus text-based health education on soil transmitted helminth (STH) infection risk behaviour of schoolchildren in China
Scientific title
Chinese schoolchildren DVD-based versus text-based health education for Soil-transmitted Helminth infection risk
Secondary ID [1] 1283 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminths: Trichuris, Ascaris, Hookworm 251935 0
Condition category
Condition code
Public Health 252117 252117 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health education DVD: narrative 10min Cartoon video. Content: story about a boy who gets infected with STH because of unhygienic bahaviour. Key messages: 1) symptoms of the disease. 2) where and how can children get infected. 3) how can disease be prevented. DVD will be shown twice in October 2010 and twice in March 2011 at each of the 30 intervention schools. The Albendazole treatment will take place twice, once after the baseline parasitological survey in October 2010 and once after the folow-up parasitological survey in June 2011.
Albendazole treatment of positives: a single oral dose of Albendazole (400mg) according to World Health Organization (WHO) guidelines.
Intervention code [1] 241353 0
Prevention
Intervention code [2] 241354 0
Treatment: Drugs
Comparator / control treatment
Standard treatment:
Traditional health education material: textbook-based general hygiene education and wallposters in school. Frequency of textbook based teaching: twice per semester, schoolyear 3-6, total of one year intervention. Wallposter: permanent during intervention.

Albendazole treatment of positives: same as for intervention group
Control group
Active

Outcomes
Primary outcome [1] 252998 0
Child's knowledge on infection risk of soil-transmitted helminth will be assessed with baseline and follow-up questionnaires.
Timepoint [1] 252998 0
Knowledge will be assessed at baseline and up to one month following the intervention
Primary outcome [2] 252999 0
Change in infection risk behaviour will be assessed with standardised behaviour observation at school during 10 days before and after intervention. Behaviour observation involves teachers observing schoolchildren's behaviour at school. With the help of an observation form the teachers assess whether the schoolchildren are 1) wearing shoes, 2) washing hands after toilet and before eating, 3) eating raw fruit and vegetables, 4) drinking unboiled tapwater, 5) defacating outside latrines.
Timepoint [2] 252999 0
infection risk behaviour will be assessed at baseline and daily up to 10 days following the intervention
Secondary outcome [1] 257768 0
Soil-transmitted helminth infection rate will be assessed by follow-up parasitological stool tests using Kato-Katz thick smear to count the parasite eggs per species.
Timepoint [1] 257768 0
Soil-transmitted helminth infection rate will be assessed once at baseline and once after the intervention. Infection rate assessments will be carried out within one month after the intervention.

Eligibility
Key inclusion criteria
pupil of school
pupil at school for duration of study
resident of selected village
informed consent obtained
age 9-11
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no informed consent
outside of specified age range
pupil will not be present for duration of study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All 4th grade students in the study area, from whom's parents' written informed consent was received, will be enrolled for the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation: A random number generation program written within SAS will be used to randomise schools into control or intervention groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2160 0
China
State/province [1] 2160 0

Funding & Sponsors
Funding source category [1] 243812 0
Charities/Societies/Foundations
Name [1] 243812 0
United Bank of Switzerland (UBS) Optimus Foundation
Country [1] 243812 0
Switzerland
Primary sponsor type
Individual
Name
Donald P McManus
Address
Molecular Parasitology Laboratory Queensland Institute of Medical Research 300 Herston Road, Brisbane, QLD 4006, Australia
Country
Australia
Secondary sponsor category [1] 237164 0
Individual
Name [1] 237164 0
Franziska Bieri
Address [1] 237164 0
Molecular Parasitology Laboratory Queensland Institute of Medical Research 300 Herston Road, Brisbane, QLD 4006, Australia
Country [1] 237164 0
Australia
Other collaborator category [1] 883 0
Individual
Name [1] 883 0
Darren Gray
Address [1] 883 0
Griffith Institute of Health and Medical Research & School of Public Health
Griffith University
Country [1] 883 0
Australia
Other collaborator category [2] 884 0
Individual
Name [2] 884 0
Yuesheng Li
Address [2] 884 0
Molecular Parasitology Laboratory Queensland Institute of Medical Research 300 Herston Road, Brisbane, Q4006, Australia
Country [2] 884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243945 0
Queensland Institute of Medical Research Human Ethics Committee
Ethics committee address [1] 243945 0
Ethics committee country [1] 243945 0
Australia
Date submitted for ethics approval [1] 243945 0
22/09/2009
Approval date [1] 243945 0
09/10/2009
Ethics approval number [1] 243945 0
P1271

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30338 0
Address 30338 0
Country 30338 0
Phone 30338 0
Fax 30338 0
Email 30338 0
Contact person for public queries
Name 13585 0
Donald P McManus
Address 13585 0
Molecular Parasitology Laboratory Queensland Institute of Medical Research 300 Herston Road, Brisbane, QLD 4006, Australia
Country 13585 0
Australia
Phone 13585 0
+61 7 33620401
Fax 13585 0
+61 7 33620104
Email 13585 0
[email protected]
Contact person for scientific queries
Name 4513 0
Donald P McManus
Address 4513 0
Molecular Parasitology Laboratory Queensland Institute of Medical Research 300 Herston Road, Brisbane, QLD 4006, Australia
Country 4513 0
Australia
Phone 4513 0
+61 7 33620401
Fax 4513 0
+61 7 33620104
Email 4513 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.