INTERVENTION TO IMPROVE HYGIENE PRACTICE AMONG PRIMARY CAREGIVERS OF ORANG ASLI (INDIGENOUS) CHILDREN UNDER THREE YEARS OLD IN KUALA LANGAT DISTRICT, SELANGOR
To develop, implement and evaluate the effectiveness of IMB-based intervention on hygiene practice among the primary caregivers of Orang Asli children under three years old in Kuala Langat District.
Design
Single blinded cluster randomized controlled trial (RCT) with pre and post (1 and 3 months) intervention evaluations
Settings and conduct
The study were held at 4 health clinics in Kuala Langat District mainly attended by the Orang Asli (indigenous) population. Only the researcher knew the group allocation (intervention or control). Individuals who were involved in assessing the outcomes (research enumerator) and administration staffs or local healthcare providers were unaware of the group assignment or allocation. Respondents in the intervention group were only aware during the first day of the intervention program.
Participants/Inclusion and exclusion criteria
Inclusion criteria
a. Primary caregivers with at least one Orang Asli children aged between 6 months to 3 years old
b. Primary caregivers age is more than 18 years old
c. Able to understand Malay Language
Exclusion criteria
Primary caregivers with children who have been diagnosed with any chronic diseases.
Intervention groups
The intervention group received a one day course of Information Motivation Behavioural Skills (IMB) Model based hygiene intervention module which consists of 3 main components:
a) Information - health talk related to routes of disease transmission, benefits of good hygiene practice and hygiene practices to prevent diseases;
b) Motivation - support group discussion regarding beliefs, barriers and myth related to hygiene behavior; and
c) Behavioural skills-practical session focusing on proper hand washing technique and good hygiene practice in preparing food
Main outcome variables
Improvement of hygiene practice among primary caregivers of Orang Asli children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043296N1
Registration date:2019-05-19, 1398/02/29
Registration timing:retrospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
liyanatul najwa zakaria
Name of organization / entity
University Putra Malaysia
Country
Malaysia
Phone
+60 3-8705 3873
Email address
liyanatul.zakaria@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-30, 1397/01/10
Expected recruitment end date
2018-10-30, 1397/08/08
Actual recruitment start date
2018-03-30, 1397/01/10
Actual recruitment end date
2018-10-30, 1397/08/08
Trial completion date
2018-10-30, 1397/08/08
Scientific title
INTERVENTION TO IMPROVE HYGIENE PRACTICE AMONG PRIMARY CAREGIVERS OF ORANG ASLI (INDIGENOUS) CHILDREN UNDER THREE YEARS OLD IN KUALA LANGAT DISTRICT, SELANGOR
Public title
HYGIENE PRACTICE AMONG PRIMARY CAREGIVERS OF INDIGENOUS GROUP
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primary caregivers with at least one Orang Asli children aged between 6 months to 3 years old
Primary caregivers age is more than 18 years old
Able to understand Malay Language
Exclusion criteria:
Primary caregivers with children who have been diagnosed with any chronic diseases.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
186
Actual sample size reached:
166
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization at individual level was not conducted, but instead at the cluster level (4 health clinics) by randomly allocate the clusters equally into intervention and control groups (1:1). All respondents who met the inclusion criteria were included in the study. All respondents listed from both health clinics and head of village lists were contacted and invited to participate in the study during their follow up mobile clinic. Four (4) clusters were sequentially numbered (number 1 to 4) on a piece of paper and kept in a concealed envelope. An independent person, the head of staff nurses (Matron) from the District Health Office who was not involved in this study was asked to carry out the randomization procedure. Four numbers were generated using the random sequence number generator where each cluster had an equal chance to either be in the intervention or control group (http://www.randomiser.org).
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blinded study whereby only the investigators not the respondents know the which cluster receive the intervention or being the control group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research & Ethics Committee (MREC)
Street address
Institut Pengurusan Kesihatan, Jalan Rumah Sakit
City
Kuala Lumpur
Postal code
59000
Approval date
2017-08-03, 1396/05/12
Ethics committee reference number
NMRR-17-1241-26510 (IIR)
Health conditions studied
1
Description of health condition studied
The study is a preventive medicine study to improve hygiene practice among primary caregivers of Orang Asli (indigenous) children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hygiene practice
Timepoint
1 and 3 months post intervention
Method of measurement
a validated and pre-tested questionnaire by face-to-face interviews
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
District Health Office Kuala Langat, Selangor
Full name of responsible person
Dr Wan Ahmad Razmanbin Wan Abdul Salim
Street address
Pejabat Kesihatan Daerah Kuala Langat, Jalan Morib,
City
Kuala Langat
Postal code
42700
Phone
+60 3-3187 2355
Email
pkdkualalangat@moh.gov.my
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Ass Prof Dr. Azmawani Abd Rahman
Street address
PEJABAT TIMBALAN NAIB CANSELOR (PENYELIDIKAN DAN INOVASI), Jalan Sungai Besi
City
Serdang
Postal code
43400
Phone
+60 3-8947 1002
Email
tncpi@upm.edu.my
Grant name
GP-IPS
Grant code / Reference number
GP-IPS/2018/9639900
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Putra Malaysia
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Liyanatul Najwa Zakaria
Position
Medical Officer
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
17, Jalan Mawar, Taman Mawar
City
Sepang
Province
Selangor
Postal code
43900
Phone
+60 3-8705 3873
Email
liyanatul.zakaria@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Ass Prof Halimatus Sakdiah Minhat
Position
Senior Lecturer
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
FAKULTI PERUBATAN DAN SAINS KESIHATAN, UPM
City
Serdang
Province
Selangor
Postal code
43400
Phone
+60 3-8947 2413
Email
halimatus@upm.edu.my
Person responsible for updating data
Contact
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Liyanatul Najwa Zakaria
Position
Medical Officer
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
17 jalan mawar, taman mawar
City
Sepang
Province
Selangor
Postal code
43900
Phone
+60 3-8705 3873
Email
liyanatul.zakaria@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effectiveness of IMB based intervention on hygiene practice among primary caregivers of Orang Asli children in Kuala Langat District
When the data will become available and for how long
After the data has been published
To whom data/document is available
people working in public health area
Under which criteria data/document could be used
Data on change of hygiene practice within and between trial groups post intervention will be shared. The request will be reviewed by the correspondence through email.
From where data/document is obtainable
The data can be requested through email to the correspondence Ass Prof Halimatus Sakdiah Minhat via email at halimatus@upm.edu.my
What processes are involved for a request to access data/document
The data can be requested through email to the correspondence of the study which will be replied accordingly.