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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930901
Other study ID # 202016000190-85
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2017
Est. completion date August 31, 2018

Study information

Verified date April 2019
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A health education learning package (HELP) has been improved and evaluated for its impact against intestinal parasitic infections among Orang Asli schoolchildren in West Malaysia. 13 schools were allocated into two groups (intervention and control groups) and the impact of HELP was evaluated after 3 and 6 months of baseline assessment and HELP intervention.


Description:

This study was conducted to evaluate the impact of an improved health education learning package (HELP) against intestinal parasitic infections among Orang Asli schoolchildren in West Malaysia. The package has been tested by a pilot study in 2013 among children in 2 schools in Pahang state.

In the current study, HELP package has been improved and children from 13 primary schools in 11 districts of six states in Peninsular Malaysia were allocated into two groups (intervention and control groups) and the impact of HELP was evaluated after 3 and 6 months of baseline assessment and HELP intervention.

The evaluation involved soil-transmitted helminth infections and intestinal protozoa infections.


Recruitment information / eligibility

Status Completed
Enrollment 1142
Est. completion date August 31, 2018
Est. primary completion date November 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- Grade 2 - 6

- Orang Asli ethnicity

- Schools exclusively for Orang Asli

Exclusion Criteria:

- Grade 1

- Chronic sever diseases

- no consent

- schools for mixed population groups

Study Design


Intervention

Other:
Health education learning package
Health education learning package (HELP) was introduced to children in the selected schools. The package involved different items and activities during the study period, e.g. comic booklet on the intestinal parasitic infections, stand banners, posters, lectures, songs, drawing competition, puppet show, lectures, with a toolkit that involved soap, slipper (plastic clogs shoes), & nail clipper).

Locations

Country Name City State
Malaysia University of Malaya Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Al-Delaimy AK, Al-Mekhlafi HM, Lim YA, Nasr NA, Sady H, Atroosh WM, Mahmud R. Developing and evaluating health education learning package (HELP) to control soil-transmitted helminth infections among Orang Asli children in Malaysia. Parasit Vectors. 2014 S — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Re-infection rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques Prevalence rate of Intestinal parasitic infections before and after health education 6 months
Secondary Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques Intensity rate of Intestinal parasitic infections before and after health education 6 months
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