Toybox Study Malaysia: improving healthy energy balance behaviours in pre-schoolers
| ISRCTN | ISRCTN16593038 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16593038 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Roehampton |
| Funder | Medical Research Council Newton-Ungku Omar Fund |
- 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
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
Contact information
Public
University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
| Phone | +44 (0)208 392 3000 |
|---|---|
| l.gibson@roehampton.ac.uk |
Scientific
Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
| Phone | +60 (0)3 8921 5555 |
|---|---|
| pbkoon@ukm.edu.my |
Scientific
University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
| Phone | +44 (0)208 392 3000 |
|---|---|
| c.essau@roehampton.ac.uk |
Scientific
University of Roehampton
Holybourne Ave
London
SW15 4JD
United Kingdom
| Phone | +44 (0)208 392 3000 |
|---|---|
| s.reeves@roehampton.ac.uk |
Scientific
Durham University
Stockton Road
Durham
DH1 3LE
United Kingdom
| Phone | +44 (0)1913342000 |
|---|---|
| carolyn.summerbell@durham.ac.uk |
Public
Malaysia Sarawak University (UNIMAS)
Kota Samarahan
94300 Kota Samarahan
Malaysia
| Phone | +60 (0)82 581 000 |
|---|---|
| wlcheah@unimas.my |
Public
Malaysia Sarawak University (UNIMAS)
Kota Samarahan
94300 Kota Samarahan
Malaysia
| Phone | +60 (0)82 581 000 |
|---|---|
| aclee@unimas.my |
Public
National University of Malaysia
Selangor
43600 Bangi
Malaysia
| Phone | +60 (0)3 8921 5555 |
|---|---|
| denise.koh@ukm.edu.my |
Scientific
Kebangsaan University Malaysia
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
| Phone | +60 (0)3 8921 5555 |
|---|---|
| rzt@ukm.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised control trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Improving healthy energy balance-related behaviours among preschoolers in Malaysia: feasibility of adapting the ToyBox Study |
| Study acronym | ToyBox |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Feasibility assessed using: |
| Key secondary outcome measure(s) |
1. Food and drink intakes assessed using a food frequency questionnaire pre and post intervention |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Total final enrolment | 987 |
| Key inclusion criteria | All children in the participating kindergartens between the age of 3 and 5 years will be invited to participate in the intervention |
| Key exclusion criteria | Data from children whose parents are unable to provide informed consent will be excluded from the study |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 01/03/2018 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Kuala Lumpur
50300 Kuala Lumpur
Malaysia
Sarawak
94300 Kota Samarahan
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Perspectives of teachers and parents | 01/01/2022 | 05/10/2022 | Yes | No |
| Other publications | FFQ development | 27/11/2019 | 30/01/2020 | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
