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Impact of Health Education on School Children

Primary Purpose

Intestinal Helminthiasis

Status
Completed
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Health Education package
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intestinal Helminthiasis focused on measuring Health Education, Soil-transmitted helminthiasis, Ascaris, Trichuris, Hookworm, Prevention and control

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age:7-14
  • No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation.

Exclusion Criteria:

  • Age over 15

Sites / Locations

  • National school of Pos Betau & NAtional school of Kuala Koyan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Health Education

Control

Arm Description

Deworming will be conducted in both schools. A health education package will be introduced to schoolchildren in the intervention school (School A) only. Both schools will be followed up for 6 months.

Schoolchildren in school B will serve as a control group. No intervention (Health education package) will be given after complete deworming at baseline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2012
Last Updated
June 22, 2014
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01640626
Brief Title
Impact of Health Education on School Children
Official Title
The Impact of Health Education in Controlling Soil-transmitted Helminthiasis Among Orang Asli Schoolchildren
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Helminthiasis
Keywords
Health Education, Soil-transmitted helminthiasis, Ascaris, Trichuris, Hookworm, Prevention and control

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Deworming will be conducted in both schools. A health education package will be introduced to schoolchildren in the intervention school (School A) only. Both schools will be followed up for 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Schoolchildren in school B will serve as a control group. No intervention (Health education package) will be given after complete deworming at baseline.
Intervention Type
Other
Intervention Name(s)
Health Education package
Intervention Description
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.
Primary Outcome Measure Information:
Title
1- The prevalence of intestinal parasitic infections among the Orang Asli children living in the rural areas of Pahang and Selangor will be determined.
Description
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.
Time Frame
1-2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:7-14 No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation. Exclusion Criteria: Age over 15
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed K. Al-Delaimy, MSc
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hesham M Al-Mekhlafi, PhD
Organizational Affiliation
University of Malaya
Official's Role
Study Chair
Facility Information:
Facility Name
National school of Pos Betau & NAtional school of Kuala Koyan
City
Kuala Lipis
State/Province
Pahang
Country
Malaysia

12. IPD Sharing Statement

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Impact of Health Education on School Children

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