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.
BACKGROUND: Despite the availability of physical activity (PA) interventions, many older adults are still not active enough. This might be partially explained by the often-limited effects of PA interventions. In general, health behavior change interventions often do not focus on contextual and time-varying determinants, which may limit their effectiveness. However, before the dynamic tailoring of interventions can be developed, one should know which time-dependent determinants are associated with PA and how strong these associations are. OBJECTIVE: The aim of this study was to examine within-person associations between multiple determinants of the capability, opportunity, motivation, and behavior framework assessed using Ecological Momentary Assessment (EMA) and accelerometer-assessed light PA, moderate to vigorous PA, and total PA performed at 15, 30, 60, and 120 minutes after the EMA trigger. METHODS: Observational data were collected from 64 healthy older adults (36/64, 56% men; mean age 72.1, SD 5.6 y). Participants were asked to answer a time-based EMA questionnaire 6 times per day that assessed emotions (ie, relaxation, satisfaction, irritation, and feeling down), the physical complaint fatigue, intention, intention, and self-efficacy. An Axivity AX3 was wrist worn to capture the participants' PA. Multilevel regression analyses in R were performed to examine these within-person associations. RESULTS: Irritation, feeling down, intention, and self-efficacy were positively associated with subsequent light PA or moderate to vigorous PA at 15, 30, 60, or 120 minutes after the trigger, whereas relaxation, satisfaction, and fatigue were negatively associated. CONCLUSIONS: Multiple associations were observed in this study. This knowledge in combination with the time dependency of the determinants is valuable information for future interventions so that suggestions to be active can be provided when the older adult is most receptive.
- Publikační typ
- časopisecké články MeSH
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).
- MeSH
- cvičení MeSH
- diabetes mellitus 2. typu * prevence a kontrola MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- pragmatické klinické studie jako téma MeSH
- praktické lékařství * MeSH
- prediabetes * terapie MeSH
- randomizované kontrolované studie jako téma MeSH
- sedavý životní styl MeSH
- telemedicína * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
Background: Many theoretical frameworks have been used in order to understand health behaviors such as physical activity, sufficient sleep, healthy eating habits, etc. In most research studies, determinants within these frameworks are assessed only once and thus are considered as stable over time, which leads to rather 'static' health behavior change interventions. However, in real-life, individual-level determinants probably vary over time (within days and from day to day), but currently, not much is known about these time-dependent fluctuations in determinants. In order to personalize health behavior change interventions in a more dynamic manner, such information is urgently needed. Objective: The purpose of this study was to explore the time-dependent variability of emotions, physical complaints, intention, and self-efficacy in older adults (65+) using Ecological Momentary Assessment (EMA). Methods: Observational data were collected in 64 healthy older adults (56.3% men; mean age 72.1 ± 5.6 years) using EMA. Participants answered questions regarding emotions (i.e., cheerfulness, relaxation, enthusiasm, satisfaction, insecurity, anxiousness, irritation, feeling down), physical complaints (i.e., fatigue, pain, dizziness, stiffness, shortness of breath), intention, and self-efficacy six times a day for seven consecutive days using a smartphone-based questionnaire. Generalized linear mixed models were used to assess the fluctuations of individual determinants within subjects and over days. Results: A low variability is present for the negative emotions (i.e., insecurity, anxiousness, irritation, feeling down) and physical complaints of dizziness and shortness of breath. The majority of the variance for relaxation, satisfaction, insecurity, anxiousness, irritation, feeling down, fatigue, dizziness, intention, and self-efficacy is explained by the within subjects and within days variance (42.9% to 65.8%). Hence, these determinants mainly differed within the same subject and within the same day. The between subjects variance explained the majority of the variance for cheerfulness, enthusiasm, pain, stiffness, and shortness of breath (50.2% to 67.3%). Hence, these determinants mainly differed between different subjects. Conclusions: This study reveals that multiple individual-level determinants are time-dependent, and are better considered as 'dynamic' or unstable behavior determinants. This study provides us with important insights concerning the development of dynamic health behavior change interventions, anticipating real-time dynamics of determinants instead of considering determinants as stable within individuals.
- Publikační typ
- časopisecké články MeSH
