Condition category
Not Applicable
Date applied
28/08/2018
Date assigned
02/10/2018
Last edited
23/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aim
Recent research has shown that Malaysian adolescents are more likely to have an unhealthy food intake. Therefore, it is crucial to promote healthy eating and the regular intake of meals amongst adolescents, especially in Malaysian schools, as this is where breakfast and lunch are often consumed by adolescents. Therefore, the school canteen plays an important role in influencing, creating and instilling awareness of a healthy diet in schoolchildren. Studies have shown that environmental interventions can play an important role in providing healthier food and drinks. To promote a healthy diet amongst Malaysian adolescents, a canteen-based intervention was considered necessary. This study aims to look at the feasibility and effectiveness of an intervention involving training canteen operators to provide healthy food, and promoting healthy eating practices amongst adolescents.

Who can participate?
Malaysian adolescents aged 14 years at recruitment

What does the study involve?
Six schools will be selected to participate, including schools from rural and urban areas in Selangor and Perak states. Schools will be randomly allocated into 3 groups - 2 intervention groups and 1 control group, with 2 schools in each group.
One of the intervention groups will receive canteen operator training to promote provision of healthy options. The other intervention group will also receive this training, in addition to changing food provision, which will involve a subsidy for fruit, vegetables and kuih, and free drinking water.
The control group will not experience any changes to their usual canteen service.
All schools will have their canteen menu audited by trained dieticians.
Students will have their diet history assessed, along with body measurements and focus group discussions. Sales of food and drink will also be estimated using weekly receipts from canteen operators.

What are the possible benefits and risks of participating?
Participants in this study may benefit from increased healthy options available to them and from encouragement of healthy eating. There are no known risks to participants taking part in this study.

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

Who is funding the study?
1. Academy of Science Malaysia (Newton Ungku Omar Fund) (Malaysia)
2. UK Medical Research Council between the University of Malaya and University of Bristol (UK)

Who is the main contact?
Associate Prof. Dr Hazreen Abdul Majid
hazreen@ummc.edu.my

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hazreen Abdul Majid

ORCID ID

http://orcid.org/0000-0002-2718-8424

Contact details

Department of Social and Preventive Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NMRR-18-965-41783

Study information

Scientific title

Dietary patterns and their relation to cardiometabolic health among Malaysian adolescents: a school-based intervention feasibility study

Acronym

MyHeARTBEaT

Study hypothesis

Adolescents from the intervention arm will engage with possible changes of food choices into healthy options after the intervention to a greater extent than adolescents in the control arm

Ethics approval

Medical Research Ethics Committee, University Malaya Medical Centre, 21/03/2018, MREC ID NO: 2018214-6029

Study design

Interventional quasi-experimental study

Primary study design

Interventional

Secondary study design

Quasi-experimental

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dietary intake among Malaysian adolescents

Intervention

The study will be conducted in 6 secondary schools in Malaysia. The sample will include schools from rural and urban areas in Selangor and Perak states, which will be randomised into 2 intervention arms and 1 control arm, with 2 schools in each arm, by an independent statistician using a computer-generated randomisation method. Intervention 1 will focus on training and change of food provision, whilst intervention 2 will focus on training only. The control group will not receive any intervention and will continue the usual service operation. All schools will have their canteen menu audited by trained dietitians. Study outcome measures will be assessed at the organisational level, and include 3-day diet history assessments, anthropometric measurements and focus group discussion among students conducted at baseline and post-intervention (4 weeks after intervention). Sales of food and drink items will be crudely estimated using weekly receipts from the canteen operators.

Intervention 1: Training & enabling healthy food environment
1. Training: Canteen operators will be trained to provide healthy foods and consider alternative methods for cooking by using a training manual which will be developed based on the Malaysian healthy canteen guidelines.
2. Subsidy for fruits, vegetables and low-energy dense (low ED) kuih (traditional cakes). The canteen operators will receive a weekly allowance (the amount can be revised when necessary) for the subsidy of fruit, veg and low ED kuih.
3. Providing free drinking water by installing a proper water container/tank to dispense drinking water. It can be assessed through diet history and focus group discussion with students.
4. All students (Form 2 students) will receive Ringgit Malaysia RM) valued coupons to pay for fruits (given for 2 days per week over 4 weeks) and low ED kuih (given for 2 days per week over 4 weeks).
A trained dietitian will deliver the training in these two schools and the canteens will be examined each week to assess the foods provided.

Intervention 1 will entail the adjustments to the choice of healthier food options by students which will be mainly led by the research team with the cooperation of food vendor operators. The issue of unhealthy dietary habits and practices will be addressed by encouraging and training the operators on healthy cooking methods, such as steaming and grilling.

Intervention 2: Training
Intervention 2 involves training only. Canteen operators will be trained to provide healthy foods and consider alternative methods for cooking by using a training manual which will be developed based on the Malaysian healthy canteen guidelines.

Control: Control group will receive usual practices of food service delivery by the canteen operators
The control group will receive usual practice of food service delivery by the canteen operators - there will be no changes to their food choices or delivery of service.

This study will mainly focus on altering the availability of foods/drinks in the school canteen. This 4-week intervention will be divided intervention and control group which involved 6 schools (3 from rural and 3 from urban).


Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The following will be assessed using the checklist for healthy school canteens and sales receipts from the canteen by an external evaluator at the baseline, weekly during the intervention and at the end of the intervention:
1. Feasibility of providing healthier food options at the school canteen with cooperation of the food vendors
2. Possible changes of food choices into healthy options among adolescents before and after intervention

Secondary outcome measures

1. Dietary intake (3-days diet history), assessed using a focus group with students who participate in the intervention at the baseline and at the end of the intervention:
2. Anthropometric measurements related to the health outcome, assessed at the baseline and at the end of the intervention:
2.1. Height (without socks and shoes), recorded to the nearest mm using a calibrated vertical audiometer
2.2. Weight (measured with light clothing), recorded to the nearest 0.1 kg using a digital electronic weighing scale
2.3. Waist circumference, recorded to the nearest mm using a non-elastic Seca measuring tape
2.4. Percentage body fat, measured using a portable body composition analyser

Overall trial start date

21/02/2018

Overall trial end date

15/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Malaysian adolescent
2. Aged 14 years

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

This study will be conducted among Malaysian adolescents. The sample size targeted for this study covered adolescents aged 14 years old. The total sample size will be estimated around 450 - 480 adolescents taking in to account of about 20% drop-out rate and 50 % response rate.

Total final enrolment

441

Participant exclusion criteria

1. Boarding schools
2. Religious schools
3. Vernacular schools

Recruitment start date

28/08/2018

Recruitment end date

15/04/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Social and Preventive Medicine
Faculty of Medicine, University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya

Sponsor details

Pusat Pengurusan Geran Penyelidikan
Institut Pengurusan & Pemantauan Penyelidikan (IPPP)
Aras 4
Kompleks Pengurusan Penyelidikan & Inovasi
UNIVERSITI MALAYA
Kuala Lumpur
50603 Lembah Pantai
Malaysia

Sponsor type

University/education

Website

https://www.um.edu.my/research-and-community

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

www.bristol.ac.uk/red/

Funders

Funder type

University/education

Funder name

Academy of Science Malaysia (Newton Ungku Omar Fund)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UK Medical Research Council between the University of Malaya and University of Bristol

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol of study and the results of the intervention will be published in a high-impact peer-reviewed journal in 2019.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

15/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: The intention to publish date was changed from 15/05/2020 to 15/05/2021. 21/05/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/04/2019 to 15/04/2019. 2. The overall end date was changed from 15/07/2019 to 15/05/2019. 3. The intention to publish date was changed from 15/07/2020 to 15/05/2020. 4. The total final enrolment was added. 16/10/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 20/09/2018 to 01/04/2019. 2. The overall trial end date was changed from 15/03/2019 to 15/07/2019. 3. The intention to publish date was changed from 30/05/2019 to 15/07/2020.