Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/06/2019
Date assigned
24/06/2019
Last edited
30/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
In Malaysia, levels of childhood obesity have risen considerably over the last two decades. As such strategies to treat and prevent obesity are needed urgently and it is now considered a public health priority. In particular the preschool years are an important time for establishing healthy eating and physical activity behaviours. The aim of this study is to assess the practicalities of adapting the existing European ToyBox Study intervention programme to the Malaysian kindergarten setting. The ToyBox Study Malaysia will specifically target kindergartens funded by Jabatan Kemajuan Masyarakat (KEMAS), the Community Development Department under the Ministry of Rural and Regional Development in Malaysia in two key areas: Kuala Lumpur and Sarawak on the Island of Borneo. The specific aims of the study are to: adapt the ToyBox Study programme for use in Malaysia, including translation into Bahasa Malaysia and adapting the modules to local cultures; evaluate the feasibility of the intervention by assessing the acceptability of the ToyBox Study programme to parents and kindergarten teachers; and evaluate the adapted ToyBox Study programme by comparing the effects of the Toybox Study programme to usual care in kindergartens on physical activity and health‐related behaviours and outcomes.

Who can participate?
All children in the participating kindergartens between the age of 3 and 5 years will be invited to participate in the intervention

What does the study involve?
Kindergartens are randomly allocated to deliver the Toybox Study programme or usual care. The intervention will run for 24 weeks across an entire kindergarten school year and focuses on four-targeted behaviours (drinking, snacking, physical activity, sedentary behavior) which are integrated with a lot of engagement into the daily life of the kindergarten. The ToyBox material includes newsletters, tip-cards and posters specifically designed to support parents at home too. These include information and ideas on how parents can actively and enthusiastically support their children to adopt these behaviours but also adopt them themselves and benefit the whole family.

What are the possible benefits and risks of participating?
The intervention poses no risk and it is hoped that it will benefit young children and their families achieve healthier energy balance-related behaviours that will benefit their long-term health.

Where is the study run from?
1. Universiti Kebangsaan Malaysia
2. Universiti Malaysia Sarawak (UNIMAS)

When is the study starting and how long is it expected to run for?
January 2017 to September 2019

Who is funding the study?
Medical Research Council Newton-Ungku Omar Fund

Who is the main contact?
Dr Leigh Gibson
l.gibson@roehampton.ac.uk

Trial website

http://toybox-study.my

Contact information

Type

Public

Primary contact

Dr Leigh Gibson

ORCID ID

Contact details

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
+44 (0)208 392 3000
l.gibson@roehampton.ac.uk

Type

Scientific

Additional contact

Prof Bee Koon Poh

ORCID ID

Contact details

Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
+60 (0)3 8921 5555
pbkoon@ukm.edu.my

Type

Scientific

Additional contact

Prof Cecilia Essau

ORCID ID

Contact details

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
+44 (0)208 392 3000
c.essau@roehampton.ac.uk

Type

Scientific

Additional contact

Dr Sue Reeves

ORCID ID

Contact details

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
+44 (0)208 392 3000
s.reeves@roehampton.ac.uk

Type

Scientific

Additional contact

Prof Carolyn Summerbell

ORCID ID

Contact details

Durham University
Stockton Road
Durham
DH1 3LE
United Kingdom
+44 (0)1913342000
carolyn.summerbell@durham.ac.uk

Type

Public

Additional contact

Dr Whye Lian Cheah

ORCID ID

Contact details

Malaysia Sarawak University (UNIMAS)
Kota Samarahan
94300 Kota Samarahan
Malaysia
+60 (0)82 581 000
wlcheah@unimas.my

Type

Public

Additional contact

Dr Julia Lee

ORCID ID

Contact details

Malaysia Sarawak University (UNIMAS)
Kota Samarahan
94300 Kota Samarahan
Malaysia
+60 (0)82 581 000
aclee@unimas.my

Type

Public

Additional contact

Dr Denise Koh

ORCID ID

Contact details

National University of Malaysia
Selangor
43600 Bangi
Malaysia
+60 (0)3 8921 5555
denise.koh@ukm.edu.my

Type

Scientific

Additional contact

Prof Ruzita Abd Talib

ORCID ID

Contact details

Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
+60 (0)3 8921 5555
rzt@ukm.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Improving healthy energy balance-related behaviours among preschoolers in Malaysia: feasibility of adapting the ToyBox Study

Acronym

ToyBox

Study hypothesis

The Toybox study programme will improve four energy balance-related behaviours (water drinking, snacking, physical activity and sedentary behaviour) which impact on obesity risk in children attending kindergartens in the intervention arm of the study compared to children attending kindergartens in the usual care arm of the study.

Ethics approval

1. Approved 10/01/2017, ethics committee, Faculty of Medicine and Health Sciences, University Malaysia Sarawak (94300 Kota Samarahan, Sarawak Malaysia; Tel: +60 (0)82 581 000), ref: UNIMAS/NC-21.02/03-02Jld.2(68) B
2. Approved 08/11/2017, UKM Research Ethics Committee (Level 1, Clinical Block, Chancellor Tuanku Muhriz Hospital, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 5600 Cheras, Kula Lumpur Malaysia; Tel: +603 (0)9145 5046; Email: sepukm@ukm.edu.my), ref: UKM PPI/111/8/JEP-2017-658

Study design

Pilot randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Obesity

Intervention

The original ToyBox study is an evidence-based intervention that has previously been conducted in six European countries. The ToyBox study was designed to improve four energy balanced related behaviours which impact on risk of obesity in kindergarten children, namely: drinking water, healthy meals and snacks, physical activity and sedentary behaviour. Materials from the original ToyBox study have been made available for this study to test the feasibility of this intervention in Malaysia. The ToyBox Study Malaysia intervention includes lesson plans, newsletters and age-appropriate equipment (including stories, toys, mats and colourful cups and plates) to target the four key energy balance-related behaviours.

Kindergartens will be randomly assigned to the intervention or control arm of the study. The intervention will be run in 22 KEMAS (the Community Development Department under the Ministry of Rural and Regional Development) run kindergartens: 15 in Peninsular Malaysia and 7 in Sarawak with 18 and 8 control kindergartens respectively, following usual care. The intervention will run over a period of 24 weeks and measures of the four target behaviours will be made pre and post intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility assessed using:
1. Recruitment of participating kindergartens and families
2. Level of retention/drop out
3. Acceptability of the intervention and the outcome measures for stakeholders at a stakeholders workshop
4. Evaluation of the process of intention and intervention adherence; qualitative interviews and ToyBox questionnaire data

Secondary outcome measures

1. Food and drink intakes assessed using a food frequency questionnaire pre and post intervention
2. Behaviour outcomes assessed using a questionnaire pre and post intervention
3. Sedentary behaviour and physical activity assessed using accelerometers pre and post intervention
4. Height, weight and waist circumferences measured using standard World Health Organisation anthropometric protocols pre and post intervention

Overall trial start date

01/01/2017

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All children in the participating kindergartens between the age of 3 and 5 years will be invited to participate in the intervention

Participant type

All

Age group

Child

Gender

Both

Target number of participants

400

Participant exclusion criteria

Data from children whose parents are unable to provide informed consent will be excluded from the study

Recruitment start date

01/01/2018

Recruitment end date

01/03/2018

Locations

Countries of recruitment

Malaysia

Trial participating centre

Universiti Kebangsaan Malaysia
Jalan Raja Muda Aziz
Kuala Lumpur
50300 Kuala Lumpur
Malaysia

Trial participating centre

Universiti Malaysia Sarawak (UNIMAS)
94300 Kota Samarahan
Sarawak
94300 Kota Samarahan
Malaysia

Sponsor information

Organisation

University of Roehampton

Sponsor details

Holybourne Ave
Roehampton
London
SW15 4JD
United Kingdom
+44 (0)208 392 3000
l.gibson@roehampton.ac.uk

Sponsor type

University/education

Website

http://roehampton.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council Newton-Ungku Omar Fund

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The first academic paper describing the background to the Toybox Malaysia has been published: Reeves S, Poh BK, Essau C, Summerbell C, Cheah WL, Koh D, Lee JAC, Ruzita AT & Gibosn EL (2018). Toybox Study Malaysia: Improving healthy energy balance and obesity-related behaviours among pre-schoolers in Malaysia. Nutrition Bulletin, 43, 290-295.
The researchers will further disseminate the findings to other academics, researchers and clinicians through high impact journals and conference presentations.
Group results will be made available to the parents of children who participated in the project in an accessible way. The results will also be shared with policymakers through KEMAS and the Ministries of Education and Health, Malaysia.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from Dr Leigh Gibson (l.gibson@roehampton.ac.uk), all data collected should become available 01/01/2021 and for an unlimited time. Requests for any analysis should be sent to ResearchOffice@roehampton.ac.uk, for any analyses, data will be in an anonymised secure password protected format, consent was obtained for the current study but not for other subsequent studies. The researchers will endeavour to work in line with the good practice principles from the MRC data sharing policy set out here: http://www.methodologyhubs.mrc.ac.uk/files/7114/3682/3831/Datasharingguidance2015.pdf

Intention to publish date

01/02/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Reeves S, Poh BK, Essau C, Summerbell C, Cheah WL, Koh D, Lee JAC, Ruzita AT & Gibosn EL (2018). Toybox Study Malaysia: Improving healthy energy balance and obesity-related behaviours among pre-schoolers in Malaysia. Nutrition Bulletin, 43, 290-295.
2019 FFQ development in https://www.ncbi.nlm.nih.gov/pubmed/31783477 (added 30/01/2020)

Publication citations

Additional files

Editorial Notes

30/01/2020: Publication reference added. 24/06/2019: Trial's existence confirmed by funder.