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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01640626
Other study ID # University Of Malaya
Secondary ID
Status Completed
Phase Phase 1
First received July 11, 2012
Last updated June 22, 2014
Start date July 2012
Est. completion date November 2013

Study information

Verified date June 2014
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority Malaysia: Institutional Review Board
Study type Interventional

Clinical Trial Summary

There is a sever lack in application of health education intervention for Soil Transmitted Disease (STH) in rural communities and in school children among Orang Asli in Pahang in Malaysia, and also there is a lack of information on the effect of different health education aspects on STH control in Malaysia, so the investigators think that introducing such new national educational package and for the first time in Malaysian's school will help children to make some behavior changes specially for the school children aiming to use these children as an educator agents to their families and preschool brothers and sisters, to build a base for this issue and to reduce STH intensity in these rural areas, which in turn will determine the best approach to health education intervention to be applied to other rural areas in Malaysia.


Description:

The World Health Organization established that infections with STH among school¬children cause malnutrition, intellectual retardation and cognitive and educational deficits.

Although school-based intervention specifically the deworming antihelminths drugs programme were introduced into school but still Orang Asli villages in Malaysia having a high intensity and higher prevalence rate for STH, therefore the objective of this article was to review other intervention means mainly the health education intervention into school children and rural community, where most of these studies concluded that health education intervention was successful in increasing knowledge and changing some of practices among people and children which in turn decreases the prevalence and intensity of the STH. Also we think applying such intervention in Malaysia would be a benefit to change knowledge and attitude towards STH, and it will be the first research study to be applied in this field.


Recruitment information / eligibility

Status Completed
Enrollment 317
Est. completion date November 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria:

- Age:7-14

- No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation.

Exclusion Criteria:

- Age over 15

Study Design

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


Intervention

Other:
Health Education package
Health Education package that covers key health messages about the proper personal hygiene practices will be given to school children in the intervention school. The package consisted of many items such as posters, comic book, song video, competitions, drawing activities, puppet show, etc.

Locations

Country Name City State
Malaysia National school of Pos Betau & NAtional school of Kuala Koyan Kuala Lipis Pahang

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1- The prevalence of intestinal parasitic infections among the Orang Asli children living in the rural areas of Pahang and Selangor will be determined. An open-label clinical trial will be carried out to investigate the impact of health package in controlling Soil Transmitted Disease (STH) infections among Orang Asli children in rural areas of Pahang and Selangor, Malaysia. After baseline screening for the eligibility of the children, all children will be screened for STH infections. 1-2 year Yes
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