The LIGHT study: A Cognitive Behaviour Therapy based lifestyle tool to reverse type 2 diabetes

The prevalence -and incidence- of diabetes mellitus type 2 (DM2) is rising and
has reached the status of a global pandemic. Several studies demonstrated that
strict lifestyle regimes can lead to a remission of DM2. Although possible,
reversing DM2 is not easy. When trials with intensive lifestyle support end,
people typically return to old, deeply ingrained, lifestyle habits. Several
reasons for this failure to maintain an optimal lifestyle (including healthy
diet, optimal physical activity, sleep and stress) include lack of motivation,
lack of support and lack of adequate coping skills. These underlying
psychological barriers often differ between people, and a targeted -more
personalised- intervention addressing these barriers could be the key to
improving lifestyle behaviours. Of note, despite DM2 disproportionally
affecting people with a low socio-economic position (SEP), data is particularly
lacking in this group.
Although psychological barriers in sustaining a healthy lifestyle have been
assessed before, the problems that people with DM2 face are likely unique. In
particular, people with DM2 have a much higher prevalence of complications and
psychological co-morbidities such as emotional eating, depression, and
psychological distress compared to a healthy population. These psychological
factors likely prevent people with DM2 from following a healthy lifestyle, and
need to be tackled in intervention strategies, especially at the individual
level. Cognitive Behaviour Therapy (CBT) is a tool that could address this.
CBT is a type of psychotherapy that aims to change dysfunctional thoughts about
self-image and maladaptive cognitions and behaviour into more realistic ones.
It has previously been shown to be effective in treating clinical depression
and eating disorders. It furthermore managed to promote a sustainable weight
loss, which is a key factor in reversing DM2.
Preventing a relapse to old habits has been the most difficult challenge in
promoting a lifestyle change in people with DM2 and this could be effectively
tackled with CBT. However, in order to do this, we need to identify which
psychological factors are important in lifestyle behaviours in the first place.
Therefore, we will first assess these barriers and facilitators, before
developing a digital, personalised CBT tool on the platform of Greenhabit B.V.
to improve lifestyle behaviours in people with DM2. In particular we will focus
on people with a low SEP, as these have been understudied so far. To promote
acceptability of the tool and increase the chances of success, it will be
developed in co-creation sessions together with people with DM2.

1. To identify the perceived barriers and facilitators for initiating and
maintaining a healthy lifestyle in people with both DM2 and a low SEP.
2. To co-create a digital, personalised CBT lifestyle tool together with end
users (people with DM2) to promote healthy lifestyle behaviours.

We will design a quantitative cross-sectional study to collect questionnaire
data on demographic, social, clinical and psychological determinants of
lifestyle behaviours of people with DM2. We will also conduct a qualitative
study to collect more in-depth interview data on psychological determinants of
lifestyle behaviours in individuals with DM2 and low SEP. These designs will be
used to identify the perceived barriers and facilitators for initiating and
maintaining a healthy lifestyle in people with DM2 and low SEP.
Based on input from these studies, the CBT lifestyle intervention tool will be
created in collaboration with study participants in several co-creation
sessions. The CBT lifestyle intervention tool will be built into the Greenhabit
platform. In addition, we will generate recommendations for co-creation tools
using the experience of the study participants in this study.

The intervention will be a collaboratively developed CBT lifestyle tool to
promote lifestyle behaviour changes in people with Type 2 Diabetes with low SEP
on the platform of the company Greenhabit B.V.. (greenhabit.nl)
The CBT lifestyle tool will be integrated into their Artificial Intelligence
(AI)-based platform to influence lifestyle behaviour. CBT elements will be
included in the Greenhabit app. The topics that can be included and the design
will be determined based on results from the questionnaire study, interview
study and co-creation sessions.

Greenhabit will make its lifestyle intervention platform available to study
participants free of charge. The app personalises interventions (e.g. messages,
challenges, quizzes, recipes) based on user-reported data such as quality of
life, BMI and glucose levels. Due to privacy rules, this data is only available
to participants. The company will not share this data, only the frequency of
use of the platform by the participant will be shared.

A pilot RCT will be designed with an intervention and a control arm. The CBT
tool will be incorporated into the Greenhabit platform before it is offered to
a random sample of 30 study participants with DM2 and a low SEP. The program
will last 12 weeks. Controls (n=30) will continue to receive their usual care,
but will be asked to complete the same questionnaires and measurements as the
intervention group. We will collect data using questionnaires, EMA methods,
wearables (Freestyle Libre, accelerometers), and anthropometric measurements
(e.g. weight). Therewith, we will collect data on both the participant and the
tool. Among others, we will collect data on participant characteristics,
lifestyle behaviours, and health, and the use and acceptability of the tool.
This would not only allow us to identify which within-person factors determine
lifestyle behaviours, but also assess the strength of these associations over
time.
Additionally, we will assess which between-person factors may lead to
differences in effectiveness (see Table 2, e.g. psychological factors, social
and contextual factors). This will be done by including interaction terms and
performing stratified analyses for groups with and without underlying
psychological barriers (such as comorbidities, life-events or depression) that
may be particularly detrimental in them adopting a healthy lifestyle. Thus, we
can assess if there are differences between groups in the intervention's
effectiveness.
Baseline demographics such as age, sex and age of diagnosis, will be collected
at week 1 only. Questionnaires on psychological factors (e.g. optimism and
depression), diabetes-specific variables (e.g. medication use), and diet will
be conducted at week 1 and 12. EMA methods will be used to collect intensive
longitudinal data on individual (e.g. positive emotions) and social/contextual
factors (e.g. external stressors) 3 times a day for 7 days at week 1 and 12.
This data will be used to generate individual temporal networks74 for each
patient, which will be used to further personalize their individual CBT tool.
Objective data will be collected at week 1 and 12 for 5-7 days. This will cover
anthropometrics (e.g. weight and body composition, as measured by a scale),
lifestyle behaviours (physical activity, sleep, as measured by an
accelerometer) and glycemic control (defined as time in range and glycemic
variability, as measured by a flash glucose meter). Lastly, we will examine the
acceptability, usability, and feasibility of and participant satisfaction with
the developed CBT tool at week 6 and 12 with validated questionnaires and at
week 12 with semi-structured interviews. Tables 2-4 show an overview of the
measurements in the pilot RCT.

(Potential) Risks: we expect no risk for participants taking part in this
study. Time investment is what we ask from the study participants.
Participation in this study is entirely voluntary, and participants have the
autonomy to decline or choose not to answer any of the questions posed to them.

Benefits: After successful completion of the questionnaire, participants will
be offered to participate in hybrid (free) workshops where we will provide
lunch. Participants of the interview study will receive a gift card of 15
euros. During the co-creation sessions, participants will have the chance to
connect with other people with the same disease and share tips. Furthermore, if
they participate in at least 1 co-creation session, they will receive 25 euros
and travel costs reimbursed. Newsletters will be shared with participants to
inform them.