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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.

作者信息

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

机构信息

Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.

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

出版信息

Trials. 2025 May 20;26(1):166. doi: 10.1186/s13063-025-08865-z.


DOI:10.1186/s13063-025-08865-z
PMID:40394706
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12093599/
Abstract

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.

摘要

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本文引用的文献

[1]
Estimation Methods for Estimands Using the Treatment Policy Strategy; a Simulation Study Based on the PIONEER 1 Trial.

Pharm Stat. 2025

[2]
All I want for Christmas…is a precisely defined research question.

Trials. 2024-12-14

[3]
Fitbit's accuracy to measure short bouts of stepping and sedentary behaviour: validation, sensitivity and specificity study.

Digit Health. 2024-6-17

[4]
Participatory development of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED).

BMC Public Health. 2024-3-31

[5]
The estimands framework: a primer on the ICH E9(R1) addendum.

BMJ. 2024-1-23

[6]
Optimal Dose and Type of Physical Activity to Improve Glycemic Control in People Diagnosed With Type 2 Diabetes: A Systematic Review and Meta-analysis.

Diabetes Care. 2024-2-1

[7]
Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial.

Circulation. 2024-1-16

[8]
Detailed descriptions of physical activity patterns among individuals with diabetes and prediabetes: the Lolland-Falster Health Study.

BMJ Open Diabetes Res Care. 2023-9

[9]
Global Prevalence of Prediabetes.

Diabetes Care. 2023-7-1

[10]
mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial.

BMC Public Health. 2023-3-31

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