Attitude to HealthNCT06539845
Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks
A study testing Outbreak Preparedness Intervention for the Orang Asli and Educational Brochures for the Orang Asli in people with Attitude to Health and Behavior, Health, run by Universiti Teknologi Mara at 2 sites in Malaysia.
Trial summary
The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Attitude to Health, Behavior, Health, Health Behavior
- What is being tested?
- Outbreak Preparedness Intervention for the Orang Asli and Educational Brochures for the Orang Asli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesMalaysia
- Study dates
- Jun 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Orang Asli ethnicity
- Malaysian citizen
- Age between 18 to 99 years old
- The head of the household, or the person who contributes to, or influences health-related decisions for the household
- Live in a household with at least three members
- Able to converse in Malay
Who cannot join
- Having physical or cognitive disabilities (e.g., blindness, deafness, schizophrenia and dementia)
- Having severe health conditions (e.g., respiratory and cardiovascular disease requiring oxygen support such as severe asthma/chronic obstructive pulmonary disease/heart failure and congenital heart diseases)
- Residing temporarily (less than 2 years)
- Intending to relocate to a different residence within the next 2 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Enrolling by invitation
Pejabat JAKOA Daerah Gombak dan Petaling
Gombak, Selangor, 53100
- Recruiting
Pejabat JAKOA Daerah Gombak dan Petaling
Gombak, Selangor, 53100
Pejabat JAKOA Daerah Gombak dan Petaling, +60361871080, rihdwan@jakoa.gov.my
About this study
Official title: Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial
The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks.
The main questions it is looking to answer are:
Read more
- Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor?
- Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness?
- Will it lead to more proactive preparedness actions by these households?
To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures.
Participants will:
- Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions.
- Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.
- Conditions
- Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior, Health Attitude, Health Knowledge, Attitudes, Practice
- Being tested
- Outbreak Preparedness Intervention for the Orang Asli, Educational Brochures for the Orang Asli
- Keywords
- Indigenous People, Aboriginal, Preparedness, Readiness, Community Trial, Outbreak
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outbreak Preparedness Intervention for the Orang AsliBehavioural
The chosen villages will be given the intervention package, which includes a workshop, simulation exercises, and a card game, in addition to educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This entire package will be delivered once, during the workshop, after they have answered the survey at T0.
Educational Brochures for the Orang AsliBehavioural
The chosen villages will be given educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This will be given once during the first encounter with the participant, after they have answered the survey at T0.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Randomly selected Orang Asli villages will receive the intervention package along with educational brochures, through a workshop they will need to participate in once. Receives: Behavioral: Outbreak Preparedness Intervention for the Orang Asli |
| Control | Active comparator | Randomly selected Orang Asli villages that will receive the educational brochures only. Receives: Behavioral: Educational Brochures for the Orang Asli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household Preparedness Score
The combined scores of awareness/attitude and the preparedness actions of the participant in a specific area towards potential disasters. The preparedness level is measured on a 4-category scale: Fully prepared, Committed, Aware, and Least prepared or unprepared.
Measured: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Household Preparedness Matrix
Based on the "Household Preparedness Score", the level of preparedness by assigning each respondent a position on the matrix based on their questionnaire responses.
Measured: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Secondary outcomes (2)
Cognitive Preparedness score
Measures the knowledge and attitude of participant regarding outbreak and Disease X awareness Additionally, gathering insights about people's perception of possible risk hazard that may affect them including the consequences and how to mitigate. The score is derived from the total sum of marks gathered from each item within the Knowledge and Attitude domain and normalized into a scale of 0 to 1.
Measured: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Preparedness Behaviour score
Measures the current level of preparedness actions that has been done by participants. The score is derived from the total sum of marks gathered from each item within the Practice domain and normalized into a scale of 0 to 1.
Measured: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startJun 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attitude to HealthStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Universiti Putra Malaysia, Institute for Health Behavioural Research, Department of Orang Asli Development
- Responsible party
- Principal investigator, Ameerah Su'ad binti Abdul Shakor, Universiti Teknologi Mara
- Investigators
- Ameerah Su'ad Abdul Shakor, Principal investigator, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539845
- Sponsor's protocol ID
- 24-01859-NQ7
- Status last verified
- Apr 2025
- First submitted
- 1 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the published study results may be considered for sharing but will not be distributed without the consent of Universiti Teknologi Mara, the Ministry of Health Malaysia, and the Department of Orang Asli Development. Other researchers must first obtain permission from these entities. The datasets generated or analyzed during this study will not contain any identifiers and will be made available to other researchers upon request after receiving their approval. The decision regarding the extent of data to be shared will be based on the reasonableness of the request. Participants can request access to their own individual results but not to those of other participants. Additionally, participants may request access to the general final study findings or to published articles resulting from the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06539845
- Acronym / sponsor ID
- 24-01859-NQ7
- Conditions
- Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior, Health Attitude, Health Knowledge, Attitudes, Practice
- Keywords
- Indigenous People, Aboriginal, Preparedness, Readiness, Community Trial, Outbreak
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Universiti Putra Malaysia, Institute for Health Behavioural Research, Department of Orang Asli Development
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks.
The main questions it is looking to answer are:
- Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor?
- Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness?
- Will it lead to more proactive preparedness actions by these households?
To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures.
Participants will:
- Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions.
- Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Outbreak Preparedness Intervention for the Orang AsliRandomly selected Orang Asli villages will receive the intervention package along with educational brochures, through a workshop they will need to participate in once. |
| Control | Active comparator | Behavioral: Educational Brochures for the Orang AsliRandomly selected Orang Asli villages that will receive the educational brochures only. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Orang Asli ethnicity
- Malaysian citizen
- Age between 18 to 99 years old
- The head of the household, or the person who contributes to, or influences health-related decisions for the household
- Live in a household with at least three members
Key exclusion criteria (4 listed)
- Having physical or cognitive disabilities (e.g., blindness, deafness, schizophrenia and dementia)
- Having severe health conditions (e.g., respiratory and cardiovascular disease requiring oxygen support such as severe asthma/chronic obstructive pulmonary disease/heart failure and congenital heart diseases)
- Residing temporarily (less than 2 years)
- Intending to relocate to a different residence within the next 2 years
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 |
|---|---|---|
| Outbreak Preparedness Intervention for the Orang AsliThe chosen villages will be given the intervention package, which includes a workshop, simulation exercises, and a card game, in addition to educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This entire package will be delivered once, during the workshop, after they have answered the survey at T0. | Behavioural | Intervention |
| Educational Brochures for the Orang AsliThe chosen villages will be given educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This will be given once during the first encounter with the participant, after they have answered the survey at T0. | Behavioural | Control |
Primary outcome
Household Preparedness Score
Time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
The combined scores of awareness/attitude and the preparedness actions of the participant in a specific area towards potential disasters. The preparedness level is measured on a 4-category scale: Fully prepared, Committed, Aware, and Least prepared or unprepared.
Household Preparedness Matrix
Time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Based on the "Household Preparedness Score", the level of preparedness by assigning each respondent a position on the matrix based on their questionnaire responses.
2 secondary outcomes
Cognitive Preparedness score
Time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Preparedness Behaviour score
Time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the published study results may be considered for sharing but will not be distributed without the consent of Universiti Teknologi Mara, the Ministry of Health Malaysia, and the Department of Orang Asli Development. Other researchers must first obtain permission from these entities. The datasets generated or analyzed during this study will not contain any identifiers and will be made available to other researchers upon request after receiving their approval. The decision regarding the extent of data to be shared will be based on the reasonableness of the request. Participants can request access to their own individual results but not to those of other participants. Additionally, participants may request access to the general final study findings or to published articles resulting from the study.
Related trials for Attitude to Health
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
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.
Ameerah Su'ad Abdul Shakor principal investigator
Universiti Teknologi Mara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outbreak Preparedness Intervention for the Orang Asli and Educational Brochures for the Orang Asli in people with Attitude to Health and Behavior, Health, run by Universiti Teknologi Mara at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameerah Su'ad Abdul Shakor (+60332584000, ameerahsu3ad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household Preparedness Score (time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)). The study lists 2 primary outcomes in all. 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 16 Apr 2025.