{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Global Centre for Preventive Health and Nutrition, Institute for Health Transformation, School of Health and Social Development, Deakin University, Geelong, Victoria, Australia",
        "College of Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia"
      ],
      "name": "Sze Lin Yoong"
    },
    {
      "affiliations": [
        "Global Centre for Preventive Health and Nutrition, Institute for Health Transformation, School of Health and Social Development, Deakin University, Geelong, Victoria, Australia"
      ],
      "name": "Melanie Lum"
    },
    {
      "affiliations": [
        "Global Centre for Preventive Health and Nutrition, Institute for Health Transformation, School of Health and Social Development, Deakin University, Melbourne, Victoria, Australia"
      ],
      "name": "Gloria K W Leung"
    },
    {
      "affiliations": [
        "College of Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia",
        "Department of Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia"
      ],
      "name": "Nicole Pearson"
    },
    {
      "affiliations": [
        "The University of Queensland, Saint Lucia, Queensland, Australia"
      ],
      "name": "Helen Truby"
    },
    {
      "affiliations": [
        "University of the Sunshine Coast, Sippy Downs, Queensland, Australia"
      ],
      "name": "Clare Dix"
    },
    {
      "affiliations": [
        "Institute of Health Transformation, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Najma A Moumin"
    },
    {
      "affiliations": [
        "College of Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia"
      ],
      "name": "Luke Wolfenden"
    },
    {
      "affiliations": [
        "Department of Economics, Cost-effectiveness, Deakin University, Burwood, Victoria, Australia"
      ],
      "name": "Jaithri Ananthapavan"
    },
    {
      "affiliations": [
        "College of Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia"
      ],
      "name": "Alice Grady"
    },
    {
      "affiliations": [
        "University of Newcastle, Newcastle, New South Wales, Australia",
        "The University of Newcastle School of Medicine and Public Health, Callaghan, New South Wales, Australia"
      ],
      "name": "John Wiggers"
    },
    {
      "affiliations": [
        "NSW Centre for Population Health, Sydney, New South Wales, Australia"
      ],
      "name": "Tessa Delaney"
    },
    {
      "affiliations": [
        "The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Lucie Rychetnik"
    },
    {
      "affiliations": [
        "Department of Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia"
      ],
      "name": "Maria Romiti"
    },
    {
      "affiliations": [
        "Department of Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia"
      ],
      "name": "Hannah Lamont"
    },
    {
      "affiliations": [
        "Department of Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia"
      ],
      "name": "Sonya Stanley"
    },
    {
      "affiliations": [
        "Deakin University, Geelong, Victoria, Australia"
      ],
      "name": "Michelle Lim"
    },
    {
      "affiliations": [
        "University of Newcastle, Newcastle, New South Wales, Australia",
        "Hunter Medical Research Institute, Newcastle, New South Wales, Australia"
      ],
      "name": "Chris Oldmeadow"
    },
    {
      "affiliations": [
        "The Prevention Centre, Sax Institute, Sydney, New South Wales, Australia"
      ],
      "name": "Nadia Mastersson"
    },
    {
      "affiliations": [
        "College of Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia",
        "Department of Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia"
      ],
      "name": "Rachel Sutherland"
    }
  ],
  "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",
  "uid": "6eae10c6-d7bc-509a-82fe-33824b98e2fc"
}