Toybox Study Malaysia: improving healthy energy balance behaviours in pre-schoolers

ISRCTN ISRCTN16593038
DOI https://doi.org/10.1186/ISRCTN16593038
Submission date
18/06/2019
Registration date
24/06/2019
Last edited
29/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Leigh Gibson
Public

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom

Phone +44 (0)208 392 3000
Email l.gibson@roehampton.ac.uk
Prof Bee Koon Poh
Scientific

Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia

Phone +60 (0)3 8921 5555
Email pbkoon@ukm.edu.my
Prof Cecilia Essau
Scientific

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom

Phone +44 (0)208 392 3000
Email c.essau@roehampton.ac.uk
Dr Sue Reeves
Scientific

University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom

Phone +44 (0)208 392 3000
Email s.reeves@roehampton.ac.uk
Prof Carolyn Summerbell
Scientific

Durham University
Stockton Road
Durham
DH1 3LE
United Kingdom

Phone +44 (0)1913342000
Email carolyn.summerbell@durham.ac.uk
Dr Whye Lian Cheah
Public

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

Phone +60 (0)82 581 000
Email wlcheah@unimas.my
Dr Julia Lee
Public

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

Phone +60 (0)82 581 000
Email aclee@unimas.my
Dr Denise Koh
Public

National University of Malaysia
Selangor
43600 Bangi
Malaysia

Phone +60 (0)3 8921 5555
Email denise.koh@ukm.edu.my
Prof Ruzita Abd Talib
Scientific

Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia

Phone +60 (0)3 8921 5555
Email rzt@ukm.edu.my

Study information

Study designPilot randomised control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleImproving healthy energy balance-related behaviours among preschoolers in Malaysia: feasibility of adapting the ToyBox Study
Study acronymToyBox
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedObesity
InterventionThe 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 typeBehavioural
Primary outcome measureFeasibility 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 measures1. 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 study start date01/01/2017
Completion date01/09/2019

Eligibility

Participant type(s)All
Age groupChild
Lower age limit3 Years
Upper age limit5 Years
SexBoth
Target number of participants400
Total final enrolment987
Key inclusion criteriaAll children in the participating kindergartens between the age of 3 and 5 years will be invited to participate in the intervention
Key exclusion criteriaData from children whose parents are unable to provide informed consent will be excluded from the study
Date of first enrolment01/01/2018
Date of final enrolment01/03/2018

Locations

Countries of recruitment

  • Malaysia

Study participating centres

Universiti Kebangsaan Malaysia
Jalan Raja Muda Aziz
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
Universiti Malaysia Sarawak (UNIMAS)
94300 Kota Samarahan
Sarawak
94300 Kota Samarahan
Malaysia

Sponsor information

University of Roehampton
University/education

Holybourne Ave
Roehampton
London
SW15 4JD
England
United Kingdom

Phone +44 (0)208 392 3000
Email l.gibson@roehampton.ac.uk
Website http://roehampton.ac.uk
ROR logo "ROR" https://ror.org/043071f54

Funders

Funder type

Research council

Medical Research Council Newton-Ungku Omar Fund
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date01/02/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planThe 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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications FFQ development 27/11/2019 30/01/2020 Yes No
Interim results article Perspectives of teachers and parents 01/01/2022 05/10/2022 Yes No
Other publications Adaptation of the intervention for online use 20/08/2023 29/08/2023 Yes No
Other publications Process evaluation 06/06/2023 29/08/2023 Yes No
Other publications Rationale 10/08/2018 29/08/2023 Yes No

Editorial Notes

29/08/2023: Publication references added.
05/10/2022: Publication reference and total final enrolment added.
30/01/2020: Publication reference added.
24/06/2019: Trial's existence confirmed by funder.