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
Abstract Background The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inac...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | BMC Public Health |
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| Online Access: | https://doi.org/10.1186/s12889-023-15513-1 |
| _version_ | 1797853515215798272 |
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| author | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Jitka Kuhnova Jan Novak Charlotte Wahlich Andrea Jaklova Katerina Jurkova Michael Janek Dan Omcirk Vaclav Capek Iris Maes Michal Steffl Michael Ussher James J. Tufano Steriani Elavsky Delfien Van Dyck Richard Cimler Tom Yates Tess Harris Bohumil Seifert |
| author_facet | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Jitka Kuhnova Jan Novak Charlotte Wahlich Andrea Jaklova Katerina Jurkova Michael Janek Dan Omcirk Vaclav Capek Iris Maes Michal Steffl Michael Ussher James J. Tufano Steriani Elavsky Delfien Van Dyck Richard Cimler Tom Yates Tess Harris Bohumil Seifert |
| author_sort | Tomas Vetrovsky |
| collection | DOAJ |
| description | Abstract Background The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. Methods We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness 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). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. Discussion The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial’s pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. Trial registration ClinicalTrials.gov (NCT05351359, 28/04/2022). |
| first_indexed | 2024-04-09T19:51:52Z |
| format | Article |
| id | doaj.art-5d2e3dfbf5cc4c539dd572ef59b801ab |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-04-09T19:51:52Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-5d2e3dfbf5cc4c539dd572ef59b801ab2023-04-03T05:43:44ZengBMCBMC Public Health1471-24582023-03-0123111610.1186/s12889-023-15513-1mHealth 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 trialTomas Vetrovsky0Norbert Kral1Marketa Pfeiferova2Jitka Kuhnova3Jan Novak4Charlotte Wahlich5Andrea Jaklova6Katerina Jurkova7Michael Janek8Dan Omcirk9Vaclav Capek10Iris Maes11Michal Steffl12Michael Ussher13James J. Tufano14Steriani Elavsky15Delfien Van Dyck16Richard Cimler17Tom Yates18Tess Harris19Bohumil Seifert20Faculty of Physical Education and Sport, Charles UniversityInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityFaculty of Science, University of Hradec KraloveFaculty of Physical Education and Sport, Charles UniversityPopulation Health Research Institute, St George’s University of London2nd 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 University2nd Faculty of Medicine, Charles UniversityDepartment of Movement and Sports Sciences, Ghent UniversityFaculty of Physical Education and Sport, Charles UniversityPopulation Health Research Institute, St George’s University of LondonFaculty of Physical Education and Sport, Charles UniversityDepartment of Human Movement Studies, University of OstravaDepartment of Movement and Sports Sciences, Ghent UniversityFaculty of Science, University of Hradec KraloveDiabetes Research Centre, University of LeicesterPopulation Health Research Institute, St George’s University of LondonInstitute of General Practice, 1st Faculty of Medicine, Charles UniversityAbstract Background The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. Methods We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness 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). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. Discussion The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial’s pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. Trial registration ClinicalTrials.gov (NCT05351359, 28/04/2022).https://doi.org/10.1186/s12889-023-15513-1Step-countJust-in-time adaptive intervention (JITAI)Primary careFitbitActive controlSelf-monitoring |
| spellingShingle | Tomas Vetrovsky Norbert Kral Marketa Pfeiferova Jitka Kuhnova Jan Novak Charlotte Wahlich Andrea Jaklova Katerina Jurkova Michael Janek Dan Omcirk Vaclav Capek Iris Maes Michal Steffl Michael Ussher James J. Tufano Steriani Elavsky Delfien Van Dyck Richard Cimler Tom Yates Tess Harris Bohumil Seifert 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 Step-count Just-in-time adaptive intervention (JITAI) Primary care Fitbit Active control Self-monitoring |
| title | 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 |
| 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): rationale and study protocol for a pragmatic randomised controlled trial |
| 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): rationale and study protocol for a pragmatic randomised controlled trial |
| 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): rationale and study protocol for a pragmatic randomised controlled trial |
| 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): rationale and study protocol for a pragmatic randomised controlled trial |
| 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 rationale and study protocol for a pragmatic randomised controlled trial |
| topic | Step-count Just-in-time adaptive intervention (JITAI) Primary care Fitbit Active control Self-monitoring |
| url | https://doi.org/10.1186/s12889-023-15513-1 |
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