NCT01640626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

July 11, 2012

Last Update Submit

June 22, 2014

Conditions

Keywords

Health EducationSoil-transmitted helminthiasisAscarisTrichurisHookwormPrevention and control

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Health Education

ACTIVE COMPARATOR

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.

Other: Health Education package

Control

NO INTERVENTION

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

Interventions

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.

Health Education

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Age over 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National school of Pos Betau & NAtional school of Kuala Koyan

Kuala Lipis, Pahang, Malaysia

Location

MeSH Terms

Conditions

Intestinal helminthiasisHealth EducationAncylostomiasis

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHookworm InfectionsStrongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Study Officials

  • Ahmed K. Al-Delaimy, MSc

    University of Malaya

    PRINCIPAL INVESTIGATOR
  • Hesham M Al-Mekhlafi, PhD

    University of Malaya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
THE IMPACT OF HEALTH EDUCATION IN CONTROLLING SOIL-TRANSMITTED HELMINTHIASIS IN ORANG ASLI COMMUNITIES

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 16, 2012

Study Start

July 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations