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
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 pract...
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BMC
2025-05-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08865-z |
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| author | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Bohumil Seifert Vaclav Capek Katerina Jurkova Michal Steffl Richard Cimler Jitka Kuhnova Tess Harris Michael Ussher Charlotte Wahlich Katerina Malisova Jana Pelclova Jan Dygryn Steriani Elavsky Iris Maes Delfien Van Dyck Alex Rowlands Tom Yates |
| author_facet | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Bohumil Seifert Vaclav Capek Katerina Jurkova Michal Steffl Richard Cimler Jitka Kuhnova Tess Harris Michael Ussher Charlotte Wahlich Katerina Malisova Jana Pelclova Jan Dygryn Steriani Elavsky Iris Maes Delfien Van Dyck Alex Rowlands Tom Yates |
| author_sort | Tomas Vetrovsky |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9a08e49eab4646f7bd2e601e2afb2ad8 |
| institution | OA Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj-art-9a08e49eab4646f7bd2e601e2afb2ad82025-08-20T01:53:15ZengBMCTrials1745-62152025-05-0126111210.1186/s13063-025-08865-zmHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis planTomas Vetrovsky0Norbert Kral1Marketa Pfeiferova2Bohumil Seifert3Vaclav Capek4Katerina Jurkova5Michal Steffl6Richard Cimler7Jitka Kuhnova8Tess Harris9Michael Ussher10Charlotte Wahlich11Katerina Malisova12Jana Pelclova13Jan Dygryn14Steriani Elavsky15Iris Maes16Delfien Van Dyck17Alex Rowlands18Tom Yates19Faculty of Physical Education and Sport, Charles UniversityInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityFaculty of Physical Education and Sport, Charles UniversityFaculty of Physical Education and Sport, Charles UniversityFaculty of Physical Education and Sport, Charles UniversityFaculty of Science, University of Hradec KraloveFaculty of Science, University of Hradec KraloveSchool of Health & Medical Sciences, City St George’s University of LondonSchool of Health & Medical Sciences, City St George’s University of LondonSchool of Health & Medical Sciences, City St George’s University of LondonFaculty of Physical Culture, Palacky University OlomoucFaculty of Physical Culture, Palacky University OlomoucFaculty of Physical Culture, Palacky University OlomoucDepartment of Human Movement Studies, University of OstravaDepartment of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent UniversityDepartment of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent UniversityDiabetes Research Centre, University of LeicesterDiabetes Research Centre, University of LeicesterAbstract 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.https://doi.org/10.1186/s13063-025-08865-zWearablesJust-in-time adaptive intervention (JITAI)FitbitGGIRPragmatic trialEstimand framework |
| spellingShingle | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Bohumil Seifert Vaclav Capek Katerina Jurkova Michal Steffl Richard Cimler Jitka Kuhnova Tess Harris Michael Ussher Charlotte Wahlich Katerina Malisova Jana Pelclova Jan Dygryn Steriani Elavsky Iris Maes Delfien Van Dyck Alex Rowlands Tom Yates 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 Trials Wearables Just-in-time adaptive intervention (JITAI) Fitbit GGIR Pragmatic trial Estimand framework |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Wearables Just-in-time adaptive intervention (JITAI) Fitbit GGIR Pragmatic trial Estimand framework |
| url | https://doi.org/10.1186/s13063-025-08865-z |
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