BACKGROUND: Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints. OBJECTIVES: The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions. METHODS: The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation. DISCUSSION: This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results. CONCLUSIONS: The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.

Alliance for Research in Exercise Nutrition and Activity UniSA Allied Health and Human Performance University of South Australia Adelaide Australia

Department of Human Movement Studies University of Ostrava Ostrava Czech Republic

Department of Movement and Sports Sciences Faculty of Medicine and Health Sciences Ghent University Ghent Belgium

Diabetes Research Centre University of Leicester Leicester UK

Faculty of Physical Culture Palacky University Olomouc Olomouc Czech Republic

Faculty of Physical Education and Sport Charles University Prague Czech Republic

Faculty of Science University of Hradec Kralove Hradec Kralove Czech Republic

Institute for Social Marketing and Health University of Stirling Stirling UK

Institute of General Practice 1st Faculty of Medicine Charles University Prague Czech Republic

NIHR Leicester Biomedical Research Centre University Hospitals of Leicester NHS Trust and the University of Leicester Leicester UK

School of Health and Medical Sciences City St George's University of London London UK

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