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).
Hexahedral meshes are structured as a set of ordered layer of hexes which makes local topological modifications difficult to do. For instance, removing an hex generally implies to remove a complete layer of hexes. Few works focus on local topological modifications in hexahedral meshes. In this paper, we provide some results which extend and complete some existing works [1,14,15,17], proving in a first part that the flipping operations defined by M. Bern and D. Eppstein are combinatorially free and showing in a second part how to introduce a Boy surface into a dual mesh. This operation allows us to modify the parity of the number of hexes in the primal mesh, thing that can not be done by the M. Bern and D. Eppstein basis of operations. Résumé. Tout maillage hexaédrique est structuré comme un ensemble ordonné de couches de mailles. Cette structuration rend difficile les modifications topologiques locales du maillage. Par exemple, retirer une maille du maillage nécessite souvent le retrait d'une couche complète de mailles. Peu de travaux s'intéressentà ce problème. Dans ce papier, nous donnons différents résultats quiétendent et complètent des travaux existants [1, 14, 15, 17] prouvant dans une première partie que les opérations de flipping définies par M. Bern et D. Eppstein sont libres (au sens combinatoire) et montrant dans une seconde partie comment introduire concrètement une surface de Boy dans un maillage dual d'un maillage hexaédrique. Ceci permet de modifier la parité du nombre de mailles contenues dans le maillage primal, ce qui n'est pas possible avec la base d'opérations de M. Bern et D. Eppstein.
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