Intestinal HelminthiasisPhase 1NCT01640626
Impact of Health Education on School Children
A Phase 1 study testing Health Education package in people with Intestinal Helminthiasis, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Intestinal Helminthiasis
- What is being tested?
- Health Education package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteMalaysia
- Study dates
- Jul 2012to Nov 2013
- Phase
- Phase 1
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age:7-14
- No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation.
Who cannot join
- Age over 15
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National school of Pos Betau & NAtional school of Kuala Koyan
Kuala Lipis, Pahang
About this study
Official title: The Impact of Health Education in Controlling Soil-transmitted Helminthiasis Among Orang Asli Schoolchildren
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.
Read the 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.
- Conditions
- Intestinal Helminthiasis
- Being tested
- Health Education package
- Keywords
- Health Education, Soil-transmitted helminthiasis, Ascaris, Trichuris, Hookworm, Prevention and control
- Medical subject headings
- Intestinal helminthiasis, Health Education, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education packageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal HelminthiasisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Al-Delaimy, University of Malaya
- Investigators
- Ahmed K. Al-Delaimy, MSc, Principal investigator, University of MalayaHesham M Al-Mekhlafi, PhD, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640626
- Sponsor's protocol ID
- University Of Malaya
- Status last verified
- Jun 2014
- First submitted
- 11 Jul 2012
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Health Education in Controlling Soil-transmitted Helminthiasis Among Orang Asli Schoolchildren
- ClinicalTrials.gov ID
- NCT01640626
- Acronym / sponsor ID
- University Of Malaya
- Conditions
- Intestinal Helminthiasis
- Keywords
- Health Education, Soil-transmitted helminthiasis, Ascaris, Trichuris, Hookworm, Prevention and control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jul 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education | Active comparator | Other: Health Education packageDeworming 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. |
| 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age:7-14
- No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation.
Key exclusion criteria (1 listed)
- Age over 15
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 packageHealth 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. | Other | Health Education |
Primary outcome
1- The prevalence of intestinal parasitic infections among the Orang Asli children living in the rural areas of Pahang and Selangor will be determined.
Time frame: 1-2 year
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.
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 24 Jun 2014.
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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.
Ahmed K. Al-Delaimy, MSc principal investigator
University of Malaya
Hesham M Al-Mekhlafi, PhD study chair
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 Phase 1 study testing Health Education package in people with Intestinal Helminthiasis, 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 2 inclusion and 1 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 24 Jun 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1- The prevalence of intestinal parasitic infections among the Orang Asli children living in the rural areas of Pahang and Selangor will be determined. (time frame: 1-2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2014.