Intestinal Parasitic InfectionsNCT03930901
Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children
A study testing Health education learning package in people with Intestinal Parasitic Infections and Knowledge, Attitudes, Practice, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Parasitic Infections, Knowledge, Attitudes, Practice
- What is being tested?
- Health education learning package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,142 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Apr 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Grade 2 - 6
- Orang Asli ethnicity
- Schools exclusively for Orang Asli
Who cannot join
- Grade 1
- Chronic sever diseases
- no consent
- schools for mixed population groups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Schoolchildren in Malaysia
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.
Read the 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.
- Being tested
- Health education learning package
- Keywords
- Intestinal Parasitic Infections, Soil-transmitted helminth infections, Health education
- Medical subject headings
- Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education learning packageOther
Also called HELP
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Intensity rate of Intestinal parasitic infections before and after health education
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start18 Apr 2017
- Primary completion15 Nov 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal Parasitic InfectionsStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Ahmed Mohammed Nasr, University of Malaya
- Investigators
- Hesham M Al-Mekhlafi, PhD, Study director, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930901
- Sponsor's protocol ID
- 202016000190-85
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25179100
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Schoolchildren in Malaysia
- ClinicalTrials.gov ID
- NCT03930901
- Acronym / sponsor ID
- 202016000190-85
- Keywords
- Intestinal Parasitic Infections, Soil-transmitted helminth infections, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Health education learning packageChildren 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). |
| Control | No intervention | –Children in this group were examined for intestinal parasites and then treated accordingly. They were follow up for 6 months. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Grade 2 - 6
- Orang Asli ethnicity
- Schools exclusively for Orang Asli
Key exclusion criteria (4 listed)
- Grade 1
- Chronic sever diseases
- no consent
- schools for mixed population groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education learning packageAlso: HELPHealth 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 | Intervention |
Primary outcome
Re-infection rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Time frame: 6 months
Prevalence rate of Intestinal parasitic infections before and after health education
1 secondary outcome
Intensity rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Results publication: PubMed 25179100Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham M Al-Mekhlafi, PhD study director
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education learning package in people with Intestinal Parasitic Infections and Knowledge, Attitudes, Practice, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-infection rate of intestinal parasitic infections using multiple parasitological and molecular diagnostic techniques (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.