Trials · 2025
mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Vetrovsky Tomas, Kral Norbert, Pfeiferova Marketa, Seifert Bohumil, Capek Vaclav, Jurkova Katerina, Steffl Michal, Cimler Richard, Kuhnova Jitka, Harris Tess, Ussher Michael, Wahlich Charlotte, Malisova Katerina, Pelclova Jana, Dygryn Jan, Elavsky Steriani, Maes Iris, Van Dyck Delfien, Rowlands Alex, Yates Tom
Аннотация
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.
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.