Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

Sze Lin Yoong; Melanie Lum; Gloria K W Leung; Nicole Pearson; Helen Truby; Clare Dix; Najma A Moumin; Luke Wolfenden; Jaithri Ananthapavan; Alice Grady; John Wiggers; Tessa Delaney; Lucie Rychetnik; Maria Romiti; Hannah Lamont; Sonya Stanley; Michelle Lim; Chris Oldmeadow; Nadia Mastersson; Rachel Sutherland

doi:10.1136/bmjopen-2025-106436

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Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

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Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

Sze Lin Yoong, Melanie Lum, Gloria K W Leung, Nicole Pearson, Helen Truby, Clare Dix, Najma A Moumin, Luke Wolfenden, Jaithri Ananthapavan, Alice Grady, …

BMJ Open, Vol.15(11), pp.1-12

2025

DOI: https://doi.org/10.1136/bmjopen-2025-106436

PMCID: PMC12645655

PMID: 41285505

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Abstract

Introduction: Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes. Aim: To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia. Methods and analysis: This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models. Ethics and dissemination:Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders. Trial registration number: ACTRN12624000576527.

Details

Title: Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial
Authors: Sze Lin Yoong (Corresponding Author) - Deakin University
Melanie Lum - Deakin University
Gloria K W Leung - Deakin University
Nicole Pearson - Hunter New England Local Health District
Helen Truby - The University of Queensland
Clare Dix - University of the Sunshine Coast, Queensland, School of Health - Nutrition & Dietetics
Najma A Moumin - Deakin University
Luke Wolfenden - University of Newcastle Australia
Jaithri Ananthapavan - Deakin University
Alice Grady - University of Newcastle Australia
John Wiggers - University of Newcastle Australia
Tessa Delaney - New South Wales Health
Lucie Rychetnik - The University of Sydney
Maria Romiti - Hunter New England Local Health District
Hannah Lamont - Hunter New England Local Health District
Sonya Stanley - Hunter New England Local Health District
Michelle Lim - Deakin University
Chris Oldmeadow - University of Newcastle Australia
Nadia Mastersson - Sax Institute
Rachel Sutherland - University of Newcastle Australia
Publication details: BMJ Open, Vol.15(11), pp.1-12
Publisher: BMJ Group
Date published: 2025
DOI: 10.1136/bmjopen-2025-106436
ISSN: 2044-6055
PMID: 41285505; PMC12645655
Copyright note: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made.
Grant note: This trial is supported by a 2021 MRFF Maternal Health and Healthy Lifestyles grant (2022883).
Organisation Unit: School of Health - Nutrition & Dietetics
Language: English
Record Identifier: 991187545802621
Output Type: Journal article

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Web Of Science research areas: Nutrition & Dietetics

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