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Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children

Primary Purpose

Intestinal Parasitic Infections, Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Health education learning package
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intestinal Parasitic Infections focused on measuring Intestinal Parasitic Infections, Soil-transmitted helminth infections, Health education

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention

Control

Arm Description

Children in this group were examined for intestinal parasites and then treated accordingly. Then, 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).

Children in this group were examined for intestinal parasites and then treated accordingly. They were follow up for 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Intensity rate of Intestinal parasitic infections before and after health education

Full Information

First Posted
April 5, 2019
Last Updated
April 26, 2019
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03930901
Brief Title
Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children
Official Title
Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Schoolchildren in Malaysia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Parasitic Infections, Knowledge, Attitudes, Practice
Keywords
Intestinal Parasitic Infections, Soil-transmitted helminth infections, Health education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups; intervention group that involved schools where HELP will be administered and control group that involved schools that will not receive health education.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Children in this group were examined for intestinal parasites and then treated accordingly. Then, 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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in this group were examined for intestinal parasites and then treated accordingly. They were follow up for 6 months.
Intervention Type
Other
Intervention Name(s)
Health education learning package
Other Intervention Name(s)
HELP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Re-infection rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Description
Prevalence rate of Intestinal parasitic infections before and after health education
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Description
Intensity rate of Intestinal parasitic infections before and after health education
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham M Al-Mekhlafi, PhD
Organizational Affiliation
University of Malaya
Official's Role
Study Director
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25179100
Citation
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 Sep 2;7:416. doi: 10.1186/1756-3305-7-416.
Results Reference
result

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Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children

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