Dataset Information

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 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).

SUBMITTER: Vetrovsky T

PROVIDER: S-EPMC10064755 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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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): rationale and study protocol for a pragmatic randomised controlled trial.

Vetrovsky Tomas T Kral Norbert N Pfeiferova Marketa M Kuhnova Jitka J Novak Jan J Wahlich Charlotte C Jaklova Andrea A Jurkova Katerina K Janek Michael M Omcirk Dan D Capek Vaclav V Maes Iris I Steffl Michal M Ussher Michael M Tufano James J JJ Elavsky Steriani S Van Dyck Delfien D Cimler Richard R Yates Tom T Harris Tess T Seifert Bohumil B

BMC public health 20230331 1

<h4>Background</h4>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 (pr ...[more]

PMID: 36997936

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Project description:BackgroundTransformUs was a four-arm school-based intervention to increase physical activity and reduce sedentary behaviour among primary school children. Pedagogical and environmental strategies targeted the classroom, school grounds and family setting. The aims of this study were to evaluate program fidelity, dose, appropriateness, satisfaction and sustainability, and associations between implementation level and outcomes among the three intervention arms.MethodsAt baseline, 18-months (mid-intervention) and 30-months (post-intervention), teachers, parents and children completed surveys, and children wore GT3X ActiGraph accelerometers for 8 days at each time point to determine physical activity and sedentary time. Implementation data were pooled across the three intervention groups and teachers were categorised by level of implementation: (i) 'Low' (< 33% delivered); (ii) 'Moderate' (33-67% delivered); and (iii) 'High' (> 67% delivered). Linear and logistic mixed models examined between group differences in implementation, and the association with children's physical activity and sedentary time outcomes. Qualitative survey data were analysed thematically.ResultsAmong intervention recipients, 52% (n = 85) of teachers, 29% (n = 331) of parents and 92% (n = 407) of children completed baseline evaluation surveys. At 18-months, teachers delivered on average 70% of the key messages, 65% set active/standing homework, 30% reported delivering > 1 standing lesson/day, and 56% delivered active breaks per day. The majority of teachers (96%) made activity/sports equipment available during recess and lunch, and also used this equipment in class (81%). Fidelity and dose of key messages and active homework reduced over time, whilst fidelity of standing lessons, active breaks and equipment use increased. TransformUs was deemed appropriate for the school setting and positively received. Implementation level and child behavioural outcomes were not associated. Integration of TransformUs into existing practices, children's enjoyment, and teachers' awareness of program benefits all facilitated delivery and sustainability.ConclusionsThis study demonstrated that intervention dose and fidelity increased over time, and that children's enjoyment, senior school leadership and effective integration of interventions into school practices facilitated improved intervention delivery and sustainability. Teacher implementation level and child behavioural outcomes were unrelated, suggesting intervention efficacy was achieved irrespective of implementation variability. The potential translatability of TransformUs into practice contexts may therefore be increased. Findings have informed scale-up of TransformUs across Victoria, Australia.Trial registrationInternational Standard Randomized Controlled Trial Number ISRCTN83725066; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279. Registered 19 August 2009. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=308387&isReview=true.