{
  "abstract": "Introduction Early childhood obesity has become a major public health concern globally. The preschool period (ages 4–6 years) represents a critical window for obesity prevention due to its long-term implications on growth trajectories and behaviour formation. However, existing evidence for effective interventions targeting this age group remains limited and inconsistent, particularly in low- and middle-income countries.Methods and analysis The Peking University-Smart Monitoring and Responsive Technology for Early Childhood Health is a cluster-randomised controlled trial designed to evaluate the effectiveness and sustainability of a multi-component, digital health–assisted obesity prevention intervention. The trial involves approximately 980 children aged 4–6 years (middle and senior kindergarten classes) from 14 kindergartens, randomly allocated to either the intervention (n=7) or control (n=7) groups. The intervention spans 9 months, followed by a 12-month post-intervention follow-up. Interventions are delivered across kindergartens, families and healthcare systems. A digital Smart Health Platform is integrated into the intervention to provide health education, real-time feedback and interactive support, enabling personalised health management and promoting parental engagement. Data are collected at baseline, 4, 9 and 21 months. The primary outcome is the between-group difference in changes in body mass index Z-score at 9 months. Secondary outcomes include other anthropometric indicators, dietary intake, physical activity levels and other measurements. In addition, a process evaluation will be conducted to assess fidelity and participant engagement, and a health economic evaluation will estimate cost-effectiveness and cost-benefit outcomes.Ethics and dissemination Ethical approval for this study was obtained from the Ethics Committee of the Shandong Maternal and Child Health Hospital (no. 2025-042). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations to inform future childhood obesity prevention policies and practices.Trial registration number NCT07117149.",
  "authors": [
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Li Zhang"
    },
    {
      "affiliations": [
        "Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, Beijing, China",
        "National Health Commission Key Laboratory of Reproductive Health, Beijing, Beijing, China"
      ],
      "name": "Shiyu Yan"
    },
    {
      "affiliations": [
        "Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, Beijing, China",
        "National Health Commission Key Laboratory of Reproductive Health, Beijing, Beijing, China"
      ],
      "name": "Chunjie Yin"
    },
    {
      "affiliations": [
        "School of Public Health, Shandong Second Medical University, Weifang, China"
      ],
      "name": "Yuge Zhang"
    },
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Huijuan Liu"
    },
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Mai Gao"
    },
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Zhenyu Zhang"
    },
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Xuexia Duan"
    },
    {
      "affiliations": [
        "Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, Beijing, China",
        "National Health Commission Key Laboratory of Reproductive Health, Beijing, Beijing, China"
      ],
      "name": "Haijun Wang"
    },
    {
      "affiliations": [
        "Clinical Research Center for Children’s Health and Diseases, Shandong Provincial Maternal and Child Health Care Hospital affiliated to Qingdao University, Jinan, Shandong, China"
      ],
      "name": "Yan Li"
    }
  ],
  "title": "Protocol for a digital health-assisted cluster randomised controlled trial to prevent obesity in preschool children in Jinan, China",
  "uid": "4b90628e-5c7e-523c-8b63-3ba6f7252316"
}
