2024 Article 18384
2024 Article 18384
2024 Article 18384
Abstract
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
*Correspondence:
Tomas Vetrovsky
[email protected]
Full list of author information is available at the end of the article
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Novak et al. BMC Public Health (2024) 24:927 Page 2 of 15
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.
Keywords Primary care, Just-in-time adaptive intervention (JITAI), Self-regulation theory, Fitbit, Wearables, Phone
counselling, Text messages, Participatory development, Walking, Behaviour change techniques
This paper aims to describe the participatory devel- MS, TY)– some of whom have extensive expertise with
opment and piloting of the mHealth intervention and diabetes patients (TH, TY)– as well as psychologists and
its final version to be evaluated in the ENERGISED behavioural scientists (MU, SE, CW), and IT experts
trial, complementing the previously published trial (JK, RC). The perspectives of GPs were deemed particu-
protocol [32]. Our decision to employ a participatory larly crucial, as they are the primary agents tasked with
approach was driven by the recognition that the success the intervention implementation in real-world settings
of mHealth interventions, particularly in the context of and they have day-to-day experience of consultations
physical activity and sedentary behaviour change, hinges addressing physical inactivity with their (pre)diabetes
on their relevance and adaptability to the end-users’ daily patients. Engaging GPs early in the intervention develop-
lives and challenges [33, 34]. This approach aligns with ment process was vital for identifying and overcoming
contemporary best practices in intervention design [35], potential barriers to implementation, such as time con-
which advocate for the active involvement of potential straints and integration into existing workflows, while
users to ensure interventions are not only effective in leveraging facilitators like the trusted GP-patient rela-
theory, but also embraced and utilised in practice [36]. tionship and the GPs’ unique insights into patient needs
By involving patients with prediabetes and type 2 dia- and preferences [25, 31]. This approach aligns with prior
betes in the development process, we aimed to ensure research indicating that the early involvement of key
that the intervention was grounded in the real-world stakeholders, especially those directly impacted by the
experiences and needs of those it seeks to support [37], intervention’s implementation, significantly enhances the
thereby enhancing its potential for a significant and last- feasibility and acceptability of health interventions [41].
ing impact and scalability to a broad population of (pre) The four GPs involved in the conceptualisation phase
diabetes patients within primary care. represented a diverse cross-section of practice settings,
including both rural (MP) and urban (BS, NK) environ-
Methods and results ments, and brought a range of experiences, with years
The mHealth intervention was developed according of practice varying from recently qualified (MP) to over
to the ‘mHealth development and evaluation frame- 30 years of experience (BS, TH). This diversity ensured
work’, which includes active participation of the target a broad spectrum of insights into the challenges and
audience in focus groups and interviews [38–40]. This opportunities of implementing the intervention across
framework encompasses four sequential phases: (a) con- different healthcare contexts. The team included both
ceptualisation, (b) formative research, (c) pre-testing, and male and female GPs, with three from the Czech Repub-
(d) piloting. lic—where the intervention is to be implemented—to
We present a combined overview of the methods and ensure the intervention’s relevance to the local health-
results for each phase, providing a cohesive narrative that care system. Additionally, we included a GP from the UK
aligns the development process with the correspond- (TH) with additional experience of delivering physical
ing outcomes, rather than separating out methods and activity trials in primary care to incorporate an exter-
results. We then present the finalised intervention, as nal perspective. This helped to enrich the intervention’s
implemented in the ongoing ENERGISED randomised development, with broader insights into its potential
controlled trial. applicability and scalability beyond the initial setting.The
process began with individual team members thoroughly
Participants reviewing the latest evidence in their respective fields
All participants involved in the intervention’s develop- related to physical activity, diabetes management, behav-
ment were patients with (pre)diabetes who fulfilled the iour change theories, mHealth technologies, and inter-
ENERGISED trial eligibility criteria (Additional file 1), ventions related to all these areas, including our prior
recruited by collaborating GPs from their practices in research [40, 42–45]. Following this, a series of meetings
Prague, Czech Republic. were convened, where team members presented their
The Ethics Committee of the General University Hospi- findings and proposed elements for the intervention’s
tal in Prague (No. 49/20) provided study approval, and all design. During these meetings, facilitated discussions
participants provided informed consent. were held to integrate the diverse perspectives of the
team, whilst considering resource and time constraints.
Phase 1: conceptualisation The discussions were structured around several key
Methods conceptual aspects: underpinning theory and behaviour
To reach a consensus on the key conceptual aspects of change techniques (BCTs); mode of physical activity and
the intervention, the multidisciplinary team employed intervention goals; intervention components; and the
an informal decision-making process. This team com- required IT solution. The outcome of this process was a
prised GPs (BS, MP, NK, TH), PA researchers (DVD, JP, document, drafted by one of the researchers (TV), which
Novak et al. BMC Public Health (2024) 24:927 Page 4 of 15
outlined the agreed-upon key conceptual aspects form- cues (7.1) play a crucial role in nudging patients towards
ing the foundation of the intervention. This document, increased PA and reduced sedentary behaviour in real-
accompanied by a rationale for each aspect, was reviewed time. While not commonly used in traditional PA inter-
and approved by the entire team, guiding the subsequent ventions, prompts are massively utilised by mHealth
phases of intervention development. interventions, which facilitate easy implementation of
timely reminders or suggestions, often based on real-
Results time wearable sensor data [53, 55, 56].
Theoretical underpinning and behaviour change tech- Collectively, these BCTs form the backbone of our
niques The mHealth intervention was underpinned by intervention, each contributing uniquely to fostering
the theory of self-regulation, a psychological framework a sustained increase in PA and a decrease in sedentary
that emphasises the role of self-directed processes in behaviour among our target population.
guiding one’s behaviour towards achieving personal goals
[46]. The intervention thus incorporates a range of self- Mode of physical activity and intervention goals We
regulatory BCTs, such as self-monitoring, goal setting, identified walking as the primary mode of PA for the
and feedback [47], to which we have allocated the same intervention due to its accessibility, low cost, established
numerical codes in brackets as per Michie et al. taxonomy benefits for metabolic health [57, 58], and safety [59]. This
[48]. choice is grounded in the understanding that walking can
be seamlessly integrated into daily routines, making it a
Self-monitoring (2.3) stands as a cornerstone of self- sustainable option for most individuals [60], including
regulation, allowing patients to track their progress and patients with (pre)diabetes [57, 61]. Besides, walking can
gain insights into their PA patterns. A wealth of evidence be easily quantified as a daily step count and self-moni-
indicates that self-monitoring can significantly increase tored using pedometers or activity trackers.
PA levels [45, 49] and reduce sedentary behaviour [21, Goal setting is pivotal to the intervention; thus, we
43]. Goal setting (1.1) and regular goal review (1.5) fur- developed a set of recommended patient goals includ-
ther complement self-monitoring by providing patients ing: (a) increasing daily step count; (b) enhancing walking
with clear, tangible targets to strive for and a frame- cadence; and (c) interrupting prolonged bouts of sitting.
work to evaluate their progress. Goal-setting is the key The consensus was to advise patients to boost their
component of self-regulation [50] and one of the most daily step count by at least 3,000 above their baseline, a
potent behaviour change techniques in increasing PA common goal in behavioural interventions [59, 62, 63].
[16, 51]. A recent meta-analysis estimated that setting a This increment equates to approximately 30 min of walk-
specific goal was associated with an increase of approxi- ing, assuming a pace of 100 steps per minute—a heuris-
mately 600 steps/day [42]. Action planning (1.4) and tic estimate for a moderate-intensity threshold [64]. This
coping planning (1.2) aid in translating these goals into represents more than 150 min of moderate-intensity PA
daily routines, helping patients identify specific activi- each week, in line with the WHO’s guidelines for adults
ties, times, and contexts in which they can incorporate with chronic conditions [65]. Recognising the signifi-
more PA. Action planning has been identified as one of cance of patient autonomy, if patients find the 3,000-step
the most frequently used BCTs in the general population increase challenging, they can propose a more feasible
[51] and patients with diabetes [52]. Furthermore, com- goal, ensuring that the goal feels personally meaningful
bining action planning, coping planning, and self-moni- rather than externally imposed [66]. To offer added flex-
toring was more effective in increasing PA and reducing ibility in planning, the daily step target will be translated
sedentary behaviour than using these BCTs alone [21]. into a weekly goal by multiplying by seven, in line with
Feedback on behaviour (2.2) serves as a continuous loop WHO guidelines providing weekly rather than daily goals
of reinforcement, allowing patients to understand where [65].
they are excelling and where there’s room for improve- To ensure that patients achieve at least moderate-
ment. In a review of mHealth interventions to influence intensity levels, they will be recommended to aim for a
PA and sedentary behaviour, approximately half (46%) cadence of at least 100 steps per minute [64], initially in
utilised feedback on behaviour [53], which is also com- short durations, and gradually extending these periods
monly used in interventions targeting diabetes patients to make this cadence habitual. For example, patients
[52]. Providing information about health consequences can monitor their step count for 5 min, trying to achieve
(5.1) highlights the tangible health benefits of increased at least 500 steps, ultimately aiming for 3,000 steps in
PA and the health risks of sedentary behaviour. This tech- 30 min [63, 67, 68]. However, if the 100 steps per min-
nique aims to enhance motivation and drive behavioural ute benchmark proves challenging, they can elevate their
change, especially in patients with chronic conditions cadence as much as comfortably possible [65].
[54, 55], including (pre)diabetes [52]. Lastly, prompts and
Novak et al. BMC Public Health (2024) 24:927 Page 5 of 15
Lastly, given the positive effect of interrupting pro- [17, 18, 76]. Examples of just-in-time messages include
longed sitting bouts on metabolic markers in (pre)diabe- prompts to increase walking pace triggered when the
tes patients [8–10], they will be urged to break up sitting patient is actively walking or prompts to interrupt sit-
every 30 min for at least 3 min, during which they should ting when the patient has been sedentary for over 30 min.
either walk, preferably at moderate intensities, or per- While the full potential of such intervention can be only
form simple exercises, such as chair squats, calf raises, or realised with a smartphone plus mobile data plan, we’ve
walking in place. ensured inclusivity by accommodating patients with only
a basic cell phone with text messaging capabilities. Such
Intervention components The mHealth intervention patients will receive an adapted version of the mHealth
consists of text messages implementing various BCTs, intervention with no just-in-time messages, but equalised
some triggered ‘just in time’ based on Fitbit activity in terms of the number and types of messages delivered.
tracker data. To tailor the mHealth intervention to indi- This inclusive approach ensures that the intervention is
vidual patients and to facilitate its adoption, patients will suitable for a diverse range of participants, including
be initially supported with regular phone counselling. GPs older individuals and those from lower socioeconomic
initiate the mHealth intervention during routine health backgrounds.
check-ups and provide patients with the Fitbit tracker and
brief PA advice. Given that self-monitoring using a simple IT solution To power the mHealth intervention, we have
activity tracker has been consistently demonstrated to be adapted the HealthReact system, developed at the Uni-
effective in increasing PA levels [45, 49] and that provid- versity of Hradec Kralove [32] and compliant with rigor-
ing PA advice by GPs is considered a standard of care [69, ous data governance standards. HealthReact serves as a
70], it was deemed unethical to withhold these compo- comprehensive platform to collect, integrate, and evalu-
nents from control group participants. Therefore, in the ate sensor data, particularly from devices like the Fitbit
ENERGISED randomised controlled trial [32], Fitbit and tracker. This seamless integration facilitates the trigger-
brief advice will also be provided to the control group par- ing of just-in-time text messages based on real-time Fit-
ticipants. Additionally, this approach enables us to isolate bit recorded data. Researchers can select from a broad
the net effect of the mHealth intervention beyond the spectrum of just-in-time triggers that can be tailored to
activity tracker effect [42]. cater to individual patients’ needs. Moreover, the system
mHealth interventions typically use smartphone apps provides options to set specific parameters governing the
or text messages [71]. As (pre)diabetes is associated with delivery of text messages, for instance, regulating the total
older age and lower socioeconomic status [72], a notable number of daily messages, defining the minimum inter-
segment of (pre)diabetes patients may be unfamiliar with val between two consecutive messages, specifying the
app usage or might not possess a smartphone. Therefore, time window during which messages are triggered, and
to ensure the broad accessibility of the intervention, we setting the likelihood that a triggered message is actu-
opted to convey the mHealth component through simple ally dispatched. This level of granularity ensures that the
text messages. Text messages have been successfully used intervention remains adaptive and patient-centric while
in various health interventions [73], including those pro- also ensuring that participants receive an optimal number
moting PA [28, 71]. A recent meta-analysis of mHealth of messages.
interventions found higher effectiveness of interven-
tions including text messaging, suggesting that it can be Phase 2: formative research
explained by their higher intrusiveness when compared Methods
with smartphone apps’ notifications [16]. Focus groups were conducted at the premises of two gen-
Up until now, most messaging interventions use fixed eral practices participating in the ENERGISED trial, led
content that is neither individualised nor adapted to fluc- by a male PA researcher with PhD and MD degrees (TV)
tuations in patients’ PA. Furthermore, these messages are who had no previous relationship with the participants.
typically sent out at pre-defined times that do not respect These focus groups comprised pre(diabetes) patients
the ever-changing context of individual patients [28, 71]. conveniently sampled from the practices by the respec-
Leveraging the latest technological advancements, mes- tive GP: 7 patients (3 women, age range 53 to 66 years)
sages can be delivered just in time and adapted to the from the first practice and 7 patients (1 woman, age range
immediate context and needs of patients [74]. This pre- 63 to 78 years) from the second. The GPs welcomed the
cision is achieved by utilising data from sensors, such as participants, then left and were not present during the
those embedded in Fitbit trackers, which offer real-time focus groups that lasted 55 and 70 min, respectively. As
insights into a patient’s activity patterns [75]. Just-in-time a token of appreciation, participants were given a 20-EUR
adaptive interventions (JITAIs) have recently been shown voucher.
as effective in enhancing PA across diverse populations
Novak et al. BMC Public Health (2024) 24:927 Page 6 of 15
The objective of the focus groups was to refine the key The concept of social comparison as a BCT elicited
conceptual aspects developed in the previous phase, mixed reactions. Some participants saw value in a com-
ensuring the intervention is tailored specifically to the petitive edge: “They have a friendly competition over
needs and preferences of patients with (pre)diabetes. The who was more active, who ran the most, who cycled the
topic guide (Additional file 2) included questions about most. It certainly motivates.” This suggests that for some,
participants’ preferred PA, patterns of sedentary behav- comparing activities with others can be a strong motiva-
iour, and their experiences with using activity trackers tor. Conversely, another perspective emphasised self-ref-
and mobile apps. erenced progress: “I believe that self-comparison is key
The focus groups were audio recorded and transcribed to personal progress, especially at this age.“, indicating a
verbatim by an independent transcriber. Analysis used preference for personal benchmarks over external com-
thematic analysis with systematic data coding to iden- petition. Given these divergent views, we decided not to
tify significant patterns and themes. A female qualitative include social comparison in our intervention to avoid
researcher with a PhD degree (KJ) thoroughly read the the potential negative effects of competition and to focus
transcripts, generated initial codes and grouped the codes on individual self-improvement, which aligned with our
into potential themes using NVivo software. Themes goal of fostering intrinsic motivation.
were reviewed and refined by a second researcher (TV). The focus groups highlighted the importance of under-
The analysis was both inductive, driven by the patients’ standing the health consequences of PA: “I’m aware
accounts, and deductive, shaped by conceptual aspects that we should all be more active and that I need to lose
identified in phase 1. weight.” This acknowledgement supports the inclusion of
educational text messages to inform patients about the
Results health implications of their PA behaviours.
The formative research provided a nuanced understand-
ing of the preferences and challenges faced by individuals Walking as the primary mode of PA The focus group
with (pre)diabetes regarding PA. These insights informed discussions provided strong support for walking as the
the customisation of our intervention. Unfortunately, central PA in our intervention. Participants frequently
individual participants could not be identified from these cited walking as a preferred and accessible form of exer-
focus group transcriptions, so the individual age and cise. One participant’s experience highlighted that despite
gender of those providing quotes cannot be given in this physical health barriers, walking was still seen as a man-
section. ageable activity to increase: “I do walk and try to main-
tain a fast pace, but with the weight I’ve gained, even a
Behaviour change techniques Goal setting and regular quick 200-meter walk to the bus leaves me struggling to
review were supported by the focus group discussions. breathe.” Another participant maintained their walking
The participants’ acknowledgement of the motivational routine despite unfavourable weather: “My dog ensures
impact of setting and achieving PA targets aligns with our we go out for a walk every morning at seven, no matter if
intervention’s emphasis on goal setting: “My friend uses a it’s raining, snowing, or freezing. We usually walk for half
smartwatch to monitor his steps. He’ll notice if he’s only an hour, covering almost the entire block.” This comment
at 8,000 steps and say, ‘I need to reach at least 10,000 steps not only illustrates the practicality of walking as an exer-
today,’ and then he’s up and off to achieve it.” This quote cise that can be integrated into daily life but also shows
illustrates the motivational power of personal goals for how external motivation, such as pet ownership, can help
behaviour change, a central element of our intervention overcome environmental barriers like bad weather. These
design. insights collectively affirmed the choice of walking as the
Feedback on behaviour emerged as a crucial BCT. Par- primary mode of PA for our intervention.
ticipants expressed a preference for feedback that was
both affirming and instructive. One participant looked mHealth and wearables The formative research phase
forward to positive reinforcement: “A text message that underscored the potential of mHealth to engage patients
praises my day’s efforts in the evening and offers encour- with (pre)diabetes in managing their PA. The focus group
agement for the next day would be welcome.” Another participants expressed a general openness to using mobile
participant emphasised the importance of reflective feed- technologies, with many indicating a willingness or inter-
back to inform future actions: “I’d like an evening sum- est in using mobile phones or wearables to support their
mary that evaluates my day, suggesting what I should PA goals. One participant articulated a positive stance
start or continue doing the next day.” These insights sup- towards technology: “That would be ideal for me; I’m quite
port our intervention’s strategy of providing text mes- fond of this technology.“, while another highlighted the
sages with tailored feedback to help patients understand need for simplicity: “I would be excited to use a pedom-
their progress and plan subsequent activities. eter. I’m considering purchasing one, provided it’s not too
Novak et al. BMC Public Health (2024) 24:927 Page 7 of 15
complex to use.” These insights validate our decision to Another participant echoed this sentiment, highlighting
employ mHealth as a key intervention component, ensur- the importance of assistance in initiating a healthier life-
ing that it is both accessible and user-friendly. style: “I know I should engage in it, and I would be really
grateful for any help I can get to do so.” These statements
Just-in-time prompts The concept of just-in-time underscore the value of human interaction in motivating
prompts was well-received by the focus group par- patients to engage in PA and the essential role of counsel-
ticipants: “When I’m sitting, and my watch alerts me, it ling in supporting behaviour change.
prompts me to stand up, so I do.” This feedback validates In summary, the formative research underscored a
our decision to incorporate just-in-time prompts into the clear preference for interventions that are not only per-
intervention, utilising them as immediate nudges towards sonalised but also flexible, ensuring they can be adapted
increased PA and reduced sedentary behaviour. to the individual needs and circumstances of those with
(pre)diabetes.
Phone counselling The focus group discussions revealed
a strong preference for personalised support, which rein- Phase 3: pre-testing
forces the inclusion of phone counselling in our inter- Methods
vention. One participant expressed a desire for external In this phase, we utilised the conceptualisation refined
motivation: “I would certainly value being more physi- in phase 2 to craft various types of text messages, each
cally active, but it’s something I need to push myself to incorporating different BCTs. Each type had several
do, or else have someone else encourage and guide me.” specific examples, along with suggestions on how these
messages would be triggered. A male PhD student (JN)
Table 1 Behaviour change techniques underlying individual contacted by phone the seven patients from the second
types of text messages and their examples focus group and invited them for face-to-face semi-
Text message type Behaviour Example messages structured interviews; all invited patients accepted the
change invitation and participated in the interviews. The inter-
techniquesa views were conducted in the researcher’s office and
Walk Faster 7.1 Prompts/cues Walking fast benefits our lasted between 25 and 40 min. Participants were given a
8.3 Habit formation health tremendously. Do
20-EUR voucher.
you want to treat your
body today? Try walking a The aim of these interviews was to gather feedback
little faster. on the sample messages, which would then be used to
Stand Up 7.1 Prompts/cues We hadn’t seen any move- refine and optimise the messages in alignment with the
8.2 Behaviour ment in a while - perfect patients’ preferences and needs. To facilitate this, patients
substitution time to get some exercise were presented with these sample messages (Table 1),
or take a brisk walk. You’ll
benefit your body and feel
prompting their immediate, think-aloud reactions. The
great! interviews were audio recorded, transcribed verbatim,
Goal Review 1.5 Review behav- You managed to meet and subjected to thematic analysis using the same pro-
iour goal 80% of your weekday cess and involving the same researcher (KJ) as in phase 2.
1.6 Discrepancy target. Don’t slack off, you However, unlike in phase 2, only deductive analysis was
between current can easily catch up the employed with the themes corresponding to the different
behaviour and remaining 20% over the
goal weekend.
types of messages.
Feedback and 2.2 Feedback on You did it! You have met
Encouragement behaviour over 100% of your weekly Results
10.4 Social reward goal. Keep moving and Building on the insights from formative research, we
next week we will cel- developed a series of text messages tailored to leverage
ebrate again! specific BCTs (Table 1). The types of messages were as
Action Plan Reminder 1.4 Action A hearty walk will please
follows:
planning every dog and benefit
8.3 Habit formation everyone’s health. Try to
walk a little longer today Walk faster: just-in-time prompts to increase walking
with your friend. pace Participants responded positively to prompts that
Health Education 5.1 Information Regular short breaks from encouraged a faster walking pace while they were actually
about health sitting (e.g., 2 min of walk- walking. The just-in-time nature of these messages was
consequences ing every 30 min) have a
generally deemed crucial for their effectiveness. One par-
beneficial health effect. So,
get up and exercise/walk! ticipant expressed enthusiasm for the motivational aspect
a
The Behaviour Change Techniques were coded using the taxonomy by Michie (Male, 63 years): “Certainly, if it provides motivation, I’d
et al. [44]
Novak et al. BMC Public Health (2024) 24:927 Page 8 of 15
strive to reach the ‘excellent, keep going’ point. That’s the the morning and taking a shower in the evening, then it’s
purpose of our walks, to be meaningful.” possible to set messages for those times. For instance, I
walk my dog every evening at seven; that would be a per-
Stand up: just-in-time prompts to interrupt sit- fect time for a reminder.” This feedback reinforced the
ting Text messages to interrupt prolonged sitting were importance of personalising the intervention.
seen as potentially very effective. Participants valued the While most message types received positive feedback
reminder to break their sedentary behaviour, for example, from participants, the reception of just-in-time messages
during work hours (Female, 63 years): “I can see myself suggesting an extension of walking distance was mixed.
doing more during work. It would fit well with my rou- Some participants found them motivating (Female, 63
tine. But it’s challenging to remember to stand up, so I’d years): “Absolutely. An extra block would be manageable.”
welcome that notification.” However, others expressed neutral or negative views
(Male, 67 years): “I could extend my walk through the
Goal review: an interim review of the patient’s weekly village and back. But with heavy shopping, I don’t know,”
step goal on friday evening The text message with an and (Male, 65 years): “Walking around the house… no,
interim review of weekly step goals was met with positive that feels odd.” Consequently, we decided to exclude this
feedback, as participants valued the opportunity to reflect type of prompt from the intervention.
on their activity levels. One participant appreciated the Finally, determining the optimal frequency of text
self-monitoring aspect, recognising it as a tool for self- messages was crucial to maintaining motivation with-
improvement (Male, 63 years): “It’s a useful overview. It out causing annoyance. Participants’ preferences var-
shows what you’ve accomplished and what’s left to do, giv- ied widely, with some expressing indifference (Male, 65
ing you a chance to catch up.” This feedback underscores years): “I don’t know, I don’t care,” while others specified
the importance of such notifications in enabling patients a range (Male, 69 years): “Ideally one or two a day and no
to identify when they are falling short of their weekly tar- more than 10 a week,” and some were open to frequent
gets, providing them with the motivation to increase their prompts (Female, 63 years): “Even 6 to 7 a day wouldn’t
efforts in the remaining days of the week. bother me.” Through this feedback, it became apparent
that about 10 notifications per week would be the upper
Feedback and encouragement: Sunday evening feed- limit to ensure the messages remained a welcome nudge
back on the patient’s weekly performance and encour- rather than a nuisance.
agement for the upcoming week Most participants
valued the text message with feedback on their weekly Phase 4: piloting
performance, seeing it as a motivator for the upcoming Methods
week (Male, 69 years): “It’s beneficial to have a weekly sum- We developed a pilot version of the mHealth interven-
mary… I can aim to meet or exceed it in the next week,” tion and tested it with patients who had prediabetes or
suggesting that reflective feedback can inspire continued uncomplicated type 2 diabetes, were not on insulin ther-
or increased effort. Yet, not everyone was persuaded by apy, and were regular mobile phone users, meeting the
the numbers, with one participant stating (Male, 65 years): ENERGISED trial eligibility criteria (detailed in Addi-
“My wife might mention, ‘We’ve walked 4,000 steps,’ and tional file 1). Recruitment was conducted by collaborat-
I’d respond, ‘That’s irrelevant to me.’ I walk as much as I ing GPs as outlined in the ENERGISED trial protocol
need, whether it’s 500 steps or 5,000,” indicating a prefer- [32]. In brief, we compiled a list of all patients with (pre)
ence for intuitive rather than quantified activity. Despite diabetes from participating general practices’ computer-
such views, the consensus leaned towards the usefulness ised medical records. A random selection of 24 patients
of weekly performance feedback, affirming its inclusion in was then made from these lists, and GPs introduced the
the intervention. study to all eligible patients opportunistically during
routine health check-ups. This process resulted in the
Action plan reminder: reminders of the action plan recruitment of 10 male patients, 4 with prediabetes and 6
adapted to specific plans of each patient Participants with diabetes, aged between 40 and 76 years. The patients
were instructed to suggest their own plans for how and were equipped with the Fitbit Inspire 2 activity tracker
when they wished to incorporate walking into their daily [77] and instructed to maintain their typical PA for one
routine (e.g., walking a dog at 7 a.m. or walking home week, using the tracker to establish their baseline steps.
from work at 4 p.m.). The Action Plan Reminder message Subsequently, a researcher contacted them by phone,
was then tailored to their individual plans. The desire for assisting them in synchronising their tracker with a Fitbit
tailored messages was evident, with participants suggest- account accessible to the researchers. During this call, a
ing integration with daily routines (Female, 63 years): “If daily step goal was negotiated, and opportunities for inte-
it’s aligned with a regular activity, like brushing teeth in grating walking into their daily routines were discussed,
Novak et al. BMC Public Health (2024) 24:927 Page 9 of 15
similarly as described in the Final mHealth intervention counted the number of responses per category. Patients
section. The information collected from this conversa- participating in the pilot were allowed to keep the Fitbit
tion was instrumental in setting up and tailoring the pilot tracker.
mHealth intervention.
The pilot phase lasted two weeks, during which we Results
monitored the number of text messages patients received. During the pilot, patients received an average of 9.2 ± 10.6
After these two weeks, the same researcher reached out text messages weekly. Five felt the frequency of messages
to the patients for brief semi-structured interviews to was excessive, and two that they were sometimes sent too
gather feedback on the intervention’s usability and any closely together. Three patients found the timing of the
potential areas for improvement. Specifically, we asked just-in-time prompts to be ill-suited; for instance, some
patients about the frequency, timing, and content of the received prompts to increase their walking cadence after
messages. Patients’ responses and comments were noted completing their walk. Three participants also expressed
during and immediately after the call and were systemati- inconvenience with receiving prompts to interrupt sitting
cally categorised by one of the researchers (TV), who also during work hours when it wasn’t feasible. Lastly, five
patients felt that the message content was repetitive.
To address these issues, we implemented several inter-
Table 2 Overview of text messages comprised in the
intervention and their triggering rules vention refinements. Specifically, we adjusted the prob-
Text mes- Day Maxi- Time Trigger Probabilitya
ability of dispatching certain text messages and reduced
sage type mum window of being the maximum number of just-in-time daily prompts
number dispatched (Table 2). This ensures that most patients will receive
per day between three to six messages weekly, with only occa-
Walk Faster Daily 2 8 am– 8 5 min of 50% sional weeks exceeding ten messages. Additionally, we
(> 60 min pm 60–100
fine-tuned the parameters for triggering just-in-time
in steps/min
between) prompts related to walking cadence, minimising the like-
Walk Faster Daily 1 8 am– 8 Randomly 15% lihood of sending a prompt once walking had finished.
- Adaptedb pm within However, this adjustment potentially leads to infrequent
the time prompts for patients who engage in minimal walking. To
window address concerns about receiving prompts to interrupt
Stand Up Daily 1 4 pm– 8 30 min of 50% sitting during work hours, we restricted these prompts to
pm 0 steps/
a window between 4 pm and 8 pm. Lastly, to diversify the
min and
recorded content and reduce repetitiveness, we crafted multiple
heart rate text variations for each message type.
Stand Up Daily 1 4 pm– 8 Randomly 15%
- Adaptedc pm within Final mHealth intervention
the time The final intervention comprises six types of text mes-
window
sages, each embodying different BCTs. The individual
Goal Review Friday 1 8 pm– 10 Randomly 50%
pm within
types, examples of text messages, BCTs utilised, trigger-
the time ing rules, and probability of their dispatch are detailed
window in Tables 1 and 2. The detailed implementation of the
Feedback and Sun- 1 6 pm– 8 Randomly 50% intervention within primary care settings is thoroughly
Encourage- day pm within described in the previously published ENERGISED trial
ment the time protocol [32].
window
Walk Faster and Stand Up messages are triggered just
Action Plan Indi- 1 Individual Randomly 50%
Reminder vid- within in time by specific physical behaviour events as detected
ual the time by Fitbit sensors: 5 min with a step count ranging from
window 60 to 100 (allowing for one outlier minute below and two
Health Tues- 1 6 pm– 8 Randomly 50% above the range) between 8 am and 8 pm for Walk Faster,
Education day pm within and 30 min with zero steps while detecting heart rate (to
the time
confirm wear) between 4 and 8 pm for Stand Up mes-
window
a
Probability that a triggered message is actually dispatched, i.e., sent to the
sages. To prevent overwhelming patients, the frequency
patient. b The adapted Walk Faster messages are only sent to patients in groups of these messages is capped at one per day for Stand Up
B and C who do not receive just-in-time Walk Faster messages due to irregularity and two per day for Walk Faster (with a minimum inter-
of their Fitbit syncing pattern. c The adapted Stand Up messages are only sent to
patients in group C who do not receive just-in-time Stand Up messages due to val of 60 min between them).
none or very limited syncing of their Fitbit tracker
Novak et al. BMC Public Health (2024) 24:927 Page 10 of 15
Action Plan Reminder messages are triggered accord- of smartphones) are provided additional time-based
ing to individual participants’ routines once or more Walk Faster and Stand Up messages to make up for the
times per week. Goal Review, Feedback and Encourage- absence of just-in-time Walk Faster and Stand Up mes-
ment, and Health Education messages are triggered at sages. Furthermore, in these cases, Goal Review and
predetermined times once a week, separated throughout Feedback and Encouragement messages cannot be per-
the week. Goal Review is triggered on Friday evenings sonalised due to missing recent step count data. There-
between 8 and 10 pm, allowing participants time over the fore, they receive non-personalised messages that remind
weekend to catch up. Feedback and Encouragement mes- them to review their goals and provide encouragement.
sages are triggered on Sunday evenings between 6 and 8 Importantly, the adapted intervention is equalised in
pm, offering a review of the past week and motivation for terms of the number and types of messages delivered.
the week ahead. Health Education messages are triggered This equalisation is achieved by triggering the adapted
on Tuesdays between 6 and 8 pm. time-based Walk Faster and Stand Up messages for
Each message’s dispatch is determined by a randomi- Groups B and C only once per day, with the probability of
sation algorithm, which decides with a given probability these messages being dispatched set at 15%.
(Table 2) whether the message is actually dispatched to
the patient. For instance, the 50% probability of the Goal Procedures and counselling
Review means that the message is triggered every Friday During the baseline visit, all patients (intervention and
but only dispatched every other week on average. This control) receive a Fitbit Inspire 2 activity tracker from
randomisation not only further limits the weekly text their GP, along with brief PA advice complemented by
message count but also facilitates the future evaluation an educational leaflet and a prescription for PA. Addi-
of each message’s immediate impact on objectively mea- tionally, patients are instructed to maintain their usual
sured PA levels using a micro-randomised design. PA levels for one more week while wearing the Fitbit to
For each message type, there are various text versions establish their baseline steps.
from which one is randomly selected (Table 1). Further- Approximately one to two weeks later, intervention
more, the content of Action Plan Reminder messages patients are contacted by phone by a counsellor who
is tailored to each participant’s individual plans. Goal assists them in setting individual goals and devising an
Review and Feedback and Encouragement messages are action plan (e.g., walking a dog for 30 min on three spe-
also personalised, reflecting each participant’s step count cific days of the week). The counsellor then inputs this
from recent days. information into the HealthReact system to tailor the
Of note, all standard notifications and prompts typi- Action Plan Reminder messages and enable personalisa-
cally delivered by the Fitbit wearable and its accompany- tion of the Goal Review and Feedback and Encourage-
ing app are deliberately deactivated for both intervention ment messages.
and control participants to ensure that they do not inter- In subsequent calls at months 1 to 6 (lead-in phase) to
fere with our intervention. intervention patients, the counsellor supports patients
in reviewing their step goals and action plans, employ-
Adapted intervention ing various BCTs to facilitate goal achievement. During
For optimal functioning of the intervention, patients these calls, the counsellor can adjust the mHealth inter-
require a smartphone compatible with the HealthReact vention to adapt to the changing needs of the patients.
and Fitbit apps (Android 9.0 or iOS 15.0 and later as of For instance, if patients consistently achieve their step
November 2023), along with a mobile data plan for con- goal, the counsellor may challenge them to increase it.
tinuous internet connectivity. These patients comprise The counsellor also assists patients with technical issues
Group A. For participants lacking such resources, the related to the intervention.
intervention is modified based on the reliability of their From month 7 onwards (maintenance phase), patients
Fitbit data syncing: no longer receive phone counselling but continue to
Group B: Participants in this group who don’t sync receive text messages for an additional six months, until
their data continuously throughout the day but do sync month 12, as previously described.
regularly every day, usually in the afternoon and evening
hours (often those without a mobile data plan but with Intervention monitoring
a reliable Wi-Fi connection at home), receive additional The phone counsellors will review regular weekly reports
time-based Walk Faster messages. This approach com- of their patients’ Fitbit syncing patterns (Fig. 1). Should a
pensates for their lack of just-in-time Walk Faster mes- patient’s syncing reliability decline, they initially receive a
sages due to their syncing patterns. text message from the phone counsellor, prompting regu-
Group C: Participants who either sync irregularly or lar syncing. If this reminder proves ineffective, the coun-
not at all (including those with basic cell phones instead sellor addresses the issue in the subsequent scheduled
Novak et al. BMC Public Health (2024) 24:927 Page 11 of 15
prompts designed to increase walking cadence and inter- intervention. However, we acknowledge this as a limita-
rupt prolonged sitting can be particularly effective, as tion, recognising the value of patient involvement from
they deliver timely, context-specific nudges [17, 18]. To the earliest stages of intervention development.
broaden accessibility, including for those with limited Additionally, while our multidisciplinary research team
technology literacy, the mHealth intervention is deliv- engaged in comprehensive discussions to reach a consen-
ered in the form of text messages [16, 71]. Furthermore, sus on the key conceptual aspects of the intervention, we
we developed an adapted version of the intervention for did not employ any structured approach, such as a Delphi
patients without a mobile data plan or those with only method, in phase 1. The absence of this formal consen-
basic cell phones, ensuring inclusivity. sus method may have limited the systematic integration
Third, the involvement of patients in the intervention’s of diverse expert opinions and could be considered a
development highlighted the importance of tailoring limitation of our methodology. In addition, the absence
and personalisation. Consequently, most text messages of a structured approach precluded detailed reporting of
were designed to be individualised for each patient. For individual team members’ specific feedback in phase 1,
instance, Action Plan Reminder messages can be custom- thereby diminishing the transparency of findings derived
ised according to each participant’s specific routines and from this consultative process.
preferences. Furthermore, Feedback and Encouragement Another limitation relates to the use of Fitbit wear-
and Goal Review messages leverage individual goals and ables. While they are affordable and user-friendly, Fitbit
real-time performance data from Fitbit to provide a per- devices only sync with their server approximately every
sonalised experience for each participant. To maintain quarter of an hour. Consequently, the data triggering the
engagement and avoid monotony, we produced several just-in-time prompts can be delayed by up to 15 min-
variations of the message content and carefully regulated utes (assuming a constant internet connection), leading
the number of messages per week to prevent intervention to prompts that are ‘not-quite-in-time,’ as detailed in the
fatigue. ‘Phase 4: piloting’ section. To mitigate this, our interven-
Finally, phone counselling during the lead-in phase tion only considers data immediately preceding the sync.
of the intervention plays a pivotal role [42]. This per- However, this workaround potentially results in missed
sonal touch not only facilitates the initial adoption of triggers, especially for patients who engage in minimal
the intervention but also provides necessary support walking, leading to less frequent delivery of Walk Faster
and guidance, ensuring participants are comfortable and messages.
engaged with the technology and the overall program. Lastly, based on patient feedback, we opted to deliver
This combination of technological innovation and human Stand Up messages only from 4 pm to 8 pm to minimise
interaction was instrumental in creating an effective, negative interference with participants’ work routines
patient-centric intervention to enhance PA in (pre)diabe- and prevent annoyance. However, restricting prompts
tes patients. to interrupt sitting to this specific time frame may limit
the efficacy of the intervention, as it doesn’t address pro-
Study limitations longed sitting during a significant portion of the day.
Our study has limited generalizability due to reliance on
a small sample of patients with (pre)diabetes who partici- Conclusions
pated in the development of the mHealth intervention. The development of our mHealth intervention, rooted
Additionally, the gender imbalance in our participant in a participatory design approach, underscores the
group, with a predominance of male participants, further importance of involving patients in creating behav-
constrains generalizability. This selective group may not ioural interventions tailored to their specific needs. The
fully represent the broader population of all patients with incorporation of just-in-time prompts, which leverage
(pre)diabetes, especially those less inclined to use tech- real-time data from wearable devices, represents a sig-
nology-based solutions. Furthermore, while efforts were nificant advancement in delivering personalised and
made to enhance accessibility, the intervention’s reliance context-sensitive PA interventions for patients with (pre)
on text messaging and wearable technology presupposes diabetes. Should this approach prove effective in the
a certain level of technological literacy that may not be ongoing ENERGISED randomised controlled trial within
universally present. a primary care setting, it could significantly aid GPs in
Furthermore, our development process, guided by guiding patients towards increased PA and reduced sed-
the ‘mHealth development and evaluation framework’, entary lifestyles. The integration of mHealth tools offers a
did not involve patient partners in the initial conceptu- promising solution for GPs to overcome time constraints
alisation phase, which relied on published evidence and and enhance their capacity for behavioural counselling,
expert opinions [38–40]. This approach was chosen to leveraging the trusted patient-GP relationship. In doing
establish a strong evidence-based foundation for the so, GPs can provide continuous, personalised guidance,
Novak et al. BMC Public Health (2024) 24:927 Page 13 of 15
10
National Institute for Health Research (NIHR) Leicester Biomedical
crucial for the management of (pre)diabetes and poten- Research Centre, University Hospitals of Leicester NHS Trust and the
tially adaptable for other health conditions in routine pri- University of Leicester, Leicester, UK
mary care settings.
Received: 4 January 2024 / Accepted: 18 March 2024
Supplementary Information
The online version contains supplementary material available at https://doi.
org/10.1186/s12889-024-18384-2.
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