Condition category
Not Applicable
Date applied
11/05/2020
Date assigned
13/07/2020
Last edited
04/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Coastal areas in Malaysia can have important impacts on the livelihoods and health of local communities. Efforts by the Malaysian government to develop and improve the landscape and ecosystem have been planned; however, the progress has been relatively slow because some of the coastal areas are remote and relatively inaccessible. Thus, these coastal communities face various challenges in health, healthcare and quality of life. This study aims to investigating health, well-being and use of healthcare resources, and quality of life among the coastal communities. In addition, the relationship between the community and their coastal environment will be examined. The population of interest is the coastal communities residing within the Tun Mustapha Park in Sabah, Malaysia.

Who can participate?
Adults aged 18 years and above in the population of interest.

What does the study involve?
All participants will receive explanation of the study. Their informed consent is required before the interview can start. The study will conduct a face-to-face interview between the interviewer and the participant using administered questionnaires. in addition, the body weight, height, waist and hip circumferences, and blood pressure of the respondents will be measured by trained interviewers.

What are the possible benefits and risks of participating?
The data collected from this study will give an overview of the health status of the people in the coastal area of Taman Tun Mustapha. The results of the data analysis can be used to determine the interventions needed by the people in this area. Participants identified as having health problems during the medical screening will be referred for further examination at a nearby health facility. There are no risks of physical injury or harm by taking part in this study. The information gathered from this survey will be sensitively dealt with regarding the individuals and organizations.

Where is the study run from?
University of Malaya (Malaysia)

When is the study starting and how long is it expected to run for?
October 2017 to December 2021

Who is funding the study?
Global Challenges Research Fund (UK) and University of Malaya (Malaysia)

Who is the main contact?
Prof Dr Maznah Dahlui, maznahd@ummc.edu.my

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maznah Dahlui

ORCID ID

https://orcid.org/0000-0003-4923-9410

Contact details

Department of Social Preventive Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
+60 03-7949 2108
maznahd@ummc.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NE/P021107/1, IF052-2017

Study information

Scientific title

Health Status, Healthcare Utilisation, and Quality of Life Among the Coastal Communities in Sabah: Protocol of a population-based survey

Acronym

Study hypothesis

This study aims to identify the factors that hinder the coastal communities in Sabah from accessing and receiving appropriate healthcare services. The information gathered here will be used to design an effective intervention to improve health status and improve quality of life of the community.

Ethics approval

Approved 09/05/2019, University of Malaya Research Ethics Committee (Pusat Perkhidmatan Penyelidikan (PPP), Tingkat 2, Institut Pengurusan & Perkhidmatan Penyelidikan (IPPP), University of Malaya,
50603 Kuala Lumpur, Malaysia; +60 (0)3-7967 4973; umrec@um.edu.my), ref: UM.TNC2/UMREC - 522

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

See additional files for a participant information sheet in Malay.

Condition

Non-communicable diseases, mental health

Intervention

This is a cross-sectional study to determine health status, healthcare utilisation, and quality of life among the coastal communities in Sabah. It will be conducted for a duration of 6 months. Subsequent intervention studies will be conducted based on the findings of this study. The population of interest is the coastal communities that reside within the Tun Mustapha Park (TMP) boundary in Sabah. The main tools and instruments of data collection are questionnaires which also include a form for physical examination and observation. The questionnaire will cover topics from socio-demographic, healthcare utilization expenditure and history, lifestyle and quality of life, and interaction with the marine environment. The physical examinations of the study participants include anthropometric measurements (height, weight, waist circumference and hip circumference) and blood pressure.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Health status assessed using a questionnaire
2. Healthcare utilisation assessed using a questionnaire
3. Quality of life assessed using a questionnaire

Secondary outcome measures

1. Blood pressure measured using a calibrated OMRON M2 HEM-7120 Automatic BP Monitor
2. BMI calculated from weight and height measurements using a calibrated SECA 813 digital electronic weighing scale and a calibrated vertical SECA Portable 217 Stadiometer respectively
3. Waist:hip ratio calculated from waist and hip circumference measured using a SECA 201 Ergonomic measuring tape
4. Lifestyle assessed using a questionnaire

Overall trial start date

01/10/2017

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or above
2. Member of the household surveyed

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

First cluster = 300, Second cluster = 200, Third cluster = 100; Total Participant = 600

Participant exclusion criteria

Not part of the household surveyed

Recruitment start date

27/11/2019

Recruitment end date

29/02/2020

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Urban and Regional Planning
Faculty of Built Environment University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya

Sponsor details

Department of Urban and Regional Planning
Faculty of Built Environment
University of Malaya
Kuala Lumpur
50603
Malaysia
+60 3-7967 5376
gohhc@um.edu.my

Sponsor type

University/education

Website

https://www.um.edu.my/

Funders

Funder type

Government

Funder name

UKRI Global Challenges Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universiti Malaya

Alternative name(s)

University of Malaya

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

The study protocol is expected to be published by the end of August 2020. Four results articles are expected by the end of December 2021.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)


Publication list

Publication citations

Additional files

Editorial Notes

04/08/2020: The scientific title was changed from "Building capacity for interactions with marine ecosystems for health, well-being, food and livelihoods of coastal communities Project 6: Well-being benefits and risks of coastal living" to "Health Status, Healthcare Utilisation, and Quality of Life Among the Coastal Communities in Sabah: Protocol of a population-based survey" 13/07/2020: Uploaded participant information sheet as an additional file. 18/05/2020: Trial's existence confirmed by the University of Malaya Research Ethics Committee.