NCT03930901

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 5, 2019

Last Update Submit

April 26, 2019

Conditions

Keywords

Intestinal Parasitic InfectionsSoil-transmitted helminth infectionsHealth education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques

    6 months

Study Arms (2)

Intervention

OTHER

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).

Other: Health education learning package

Control

NO INTERVENTION

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

Interventions

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).

Also known as: HELP
Intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Grade 2 - 6
  • Orang Asli ethnicity
  • Schools exclusively for Orang Asli

You may not qualify if:

  • Grade 1
  • Chronic sever diseases
  • no consent
  • schools for mixed population groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related 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 Sep 2;7:416. doi: 10.1186/1756-3305-7-416.

MeSH Terms

Conditions

BehaviorHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Hesham M Al-Mekhlafi, PhD

    University of Malaya

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups; intervention group that involved schools where HELP will be administered and control group that involved schools that will not receive health education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 29, 2019

Study Start

April 18, 2017

Primary Completion

November 15, 2017

Study Completion

August 31, 2018

Last Updated

April 29, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations