just-in-time adaptive intervention
Dotaz
Zobrazit nápovědu
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.
- MeSH
- akcelerometrie MeSH
- cvičení * MeSH
- diabetes mellitus 2. typu * terapie psychologie diagnóza MeSH
- fitness náramky MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- nositelná elektronika MeSH
- pragmatické klinické studie jako téma MeSH
- praktické lékařství * metody MeSH
- prediabetes * terapie psychologie diagnóza MeSH
- sedavý životní styl * MeSH
- telemedicína * statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
OBJECTIVE: This study aims to assess the suitability of Fitbit devices for real-time physical activity (PA) and sedentary behaviour (SB) monitoring in the context of just-in-time adaptive interventions (JITAIs) and event-based ecological momentary assessment (EMA) studies. METHODS: Thirty-seven adults (18-65 years) and 32 older adults (65+) from Belgium and the Czech Republic wore four devices simultaneously for 3 days: two Fitbit models on the wrist, an ActiGraph GT3X+ at the hip and an ActivPAL at the thigh. Accuracy measures included mean (absolute) error and mean (absolute) percentage error. Concurrent validity was assessed using Lin's concordance correlation coefficient and Bland-Altman analyses. Fitbit's sensitivity and specificity for detecting stepping events across different thresholds and durations were calculated compared to ActiGraph, while ROC curve analyses identified optimal Fitbit thresholds for detecting sedentary events according to ActivPAL. RESULTS: Fitbits demonstrated validity in measuring steps on a short time scale compared to ActiGraph. Except for stepping above 120 steps/min in older adults, both Fitbit models detected stepping bouts in adults and older adults with sensitivities and specificities exceeding 87% and 97%, respectively. Optimal cut-off values for identifying prolonged sitting bouts achieved sensitivities and specificities greater than 93% and 89%, respectively. CONCLUSIONS: This study provides practical insights into using Fitbit devices in JITAIs and event-based EMA studies among adults and older adults. Fitbits' reasonable accuracy in detecting short bouts of stepping and SB makes them suitable for triggering JITAI prompts or EMA questionnaires following a PA or SB event of interest.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The escalating global prevalence of type 2 diabetes and prediabetes presents a major public health challenge. Physical activity plays a critical role in managing (pre)diabetes; however, adherence to physical activity recommendations remains low. The ENERGISED trial was designed to address these challenges by integrating mHealth tools into the routine practice of general practitioners, aiming for a significant, scalable impact in (pre)diabetes patient care through increased physical activity and reduced sedentary behaviour. METHODS: The mHealth intervention for the ENERGISED trial was developed according to the mHealth development and evaluation framework, which includes the active participation of (pre)diabetes patients. This iterative process encompasses four sequential phases: (a) conceptualisation to identify key aspects of the intervention; (b) formative research including two focus groups with (pre)diabetes patients (n = 14) to tailor the intervention to the needs and preferences of the target population; (c) pre-testing using think-aloud patient interviews (n = 7) to optimise the intervention components; and (d) piloting (n = 10) to refine the intervention to its final form. RESULTS: The final intervention comprises six types of text messages, each embodying different behaviour change techniques. Some of the messages, such as those providing interim reviews of the patients' weekly step goal or feedback on their weekly performance, are delivered at fixed times of the week. Others are triggered just in time by specific physical behaviour events as detected by the Fitbit activity tracker: for example, prompts to increase walking pace are triggered after 5 min of continuous walking; and prompts to interrupt sitting following 30 min of uninterrupted sitting. For patients without a smartphone or reliable internet connection, the intervention is adapted to ensure inclusivity. Patients receive on average three to six messages per week for 12 months. During the first six months, the text messaging is supplemented with monthly phone counselling to enable personalisation of the intervention, assistance with technical issues, and enhancement of adherence. CONCLUSIONS: The participatory development of the ENERGISED mHealth intervention, incorporating just-in-time prompts, has the potential to significantly enhance the capacity of general practitioners for personalised behavioural counselling on physical activity in (pre)diabetes patients, with implications for broader applications in primary care.
