Effects of the National Diabetes Challenge with or without a self-management app for personalized lifestyle advice, self-monitoring and behavior change in people with type 2 diabetes

There is a worldwide increase in the number of people with diabetes mellitus
(DM). In the Netherlands alone, over 1.2 million people have been diagnosed
with DM, and yearly 60.500 new cases are discovered. Despite the well-known
beneficial health effects of lifestyle, a large proportion of people with T2DM
fails to change their lifestyle. Research has shown that several lifestyle
interventions focused on behavior change can increase physical activity of
people with T2DM. Effective elements of such interventions where a.o. setting
realistic goals, performing the intervention in a group, monitoring own
behavior, graded exercise and social support . Such interventions are not only
effective in achieving behavior change, but also in maintaining health
behavior.
Recently, it has been shown that people with T2DM could be activated in being
physically active via a community-based intervention program: the *National
Diabetes Challenge* (NDC) program, and that such community-based approaches led
to improved quality of life and somatic health. During the yearly 20-week NDC
intervention program, participants with and without T2DM weekly walk together
in groups supervised by a health care professional. In 2018, the NDC program
ran in 204 locations with over 4.000 participants, of whom roughly 65% had
diabetes. Despite this success, there is still insufficient knowledge about the
effective mechanisms of the NDC. Potentially, the NDC can be seen as a form of
civil societal activity, which recognizes the capacity of communities and
self-organizing strengths. Additionally, it is necessary to understand how the
NDC can respond better to existing motivations and barriers to adapting a
healthier lifestyle for people with T2DM, including those who were/are not
accustomed to moving sufficiently. The focus should be on the individual as a
source of information, in order to provide personalized lifestyle advice.
Moreover, up to now the NDC has only focused on physical activity in improving
lifestyle of people with T2D, while also a healthy dietary pattern can
contribute to improved health status and even remission of T2DM. Combined
dietary and physical activity advice with behavior change support fitting the
needs of an individual can be used to further promote self-management and
health status of people with T2D. eHealth tools can contribute to increasing
skills and knowledge related to self-management of health problems. TNO
developed such an eHealth application focused on lifestyle, the so-called
*IRIS-app*. The application contains a self-learning computational model that
is able to optimize personalized advices trained by users input data. This app
empowers persons with T2DM self-management. The app starts with onboarding of
new community participants to get to know their biology and lifestyle. Users
will get control over their own personal health data, which can contribute to
better knowledge and understanding of their own health status and lifestyle.
Based on the onboarding data, personalized lifestyle interventions are offered
to promote health status. Personal goal-setting and self-monitoring are used to
achieve behavior change. Finally, the app offers tools and support in
maintaining behavior change via interventions focusing amongst others on
self-efficacy, goal-setting, motivation and relapse prevention detection.
This year, we aim to investigate the effects of a combined lifestyle
intervention on behavior, quality of life and health of people with T2DM, by
adding the TNO lifestyle app (IRIS-app) to the NDC program.

Primary Objective: to compare the effects of two interventions on lifestyle
behaviour (food intake and physical activity) and quality of life in people
with T2DM. The interventions include the National Diabetes Challenge (*NDC-only
group*), and a combined lifestyle intervention, namely the NDC with addition of
a self-management application for personalized lifestyle advice,
self-monitoring and behaviour change (*NDC+app group* and *NDC-only/app-only
group*).
The distinction between the latter two groups, *NDC+app group* and *NDC-
only/app-only group* is defined by the starting moment of app usage. In the
NDC+app group participants start using the app at the start of the NDC-program,
while in the NDC-only/app-only group participants start using the app only
after the NDC-program has ended.


Secondary Objective(s):
* * What are the effects of the combined lifestyle intervention, with and
without the app on metabolic, physiological and psychological markers of health
in people with T2DM? between the three study groups (NDC-only, NDC+app,
NDC-only/app-only)?
* Is there a change in psychosocial factors (self-efficacy, knowledge, social
support, attitude) after the intervention between the two intervention groups,
and what is their influence on the effects of the intervention (with and
without the lifestyle app) on the change in health behaviour (physical activity
and nutrition)?
* Does participation in the NDC result in increased perceived collective
efficacy, sense of community, and social capital?
* Can changes in primary and secondary outcomes be explained by the community
mechanisms and/or app acceptance and usage?

For the NDC+app group and NDC-only/app-only group also the following two
research questions will be investigated:
* What is the compliance with the app in terms of use of the app, as well as
adherence to the individually set goals?
* Is there a difference in compliance between abovementioned groups, i.e. does
app use during the NDC improve compliance as compared to app use only after the
NDC has ended?
* What is the potential of the app in maintaining the lifestyle results at the
end of the existing National Diabetes Challenge intervention (i.e.
post-intervention t=20-weeks) and/or preventing relapse into unhealthy habits
(i.e. lower physical activity and more unhealthy dietary choices) at 10-week
follow-up?

This study will be designed as a three-group intervention trial.
The interventions in this study consist of the 20-weeks National Diabetes
Challenge program (NDC-program) and the IRIS-app, a self-management app for
people with T2DM focused on lifestyle behaviour change. The NDC program is a
community-based intervention aimed at participants with (type 2)- diabetes who
walk together weekly in groups supervised by a health care professional. The
NDC is organized mainly through health care centers and general practices that
organize and supervise the weekly walks and that recruit participants for the
program. This study will make use of the existing infrastructure of the NDC, by
including a selection of the NDC locations in the study (in consultation with
the location coordinators).

All 200 (T2DM) subjects included in the intervention will follow the
NDC-program. Part of these subjects (n=75) will - on top of, and during the
NDC-program - get access to an eHealth application for self-management and
lifestyle behaviour change, the IRIS-app (*NDC+app-group*), while the other
group (n=50) does not (*NDC-only-group*). A third group (n=75) will be enrolled
in the study after the NDC-program has ended, and get access to the application
after finishing the NDC program (*NDC-only/app-only group*). The IRIS-app
contains functionalities for data ownership, personalized lifestyle advice,
goal-setting, monitoring and feedback, and behavioural change support.

All participants will fill out questionnaires and undergo anthropometric
measurements (standard measurements).
In participants in the NDC-only group and the NDC+app-group clinical parameters
will be measured via venous blood sampling at local medical diagnostic centres
(MDC). Due to logistic difficulties of offering blood collection after the
NDC-program has ended (subjects are not recruited via NDC locations, so NDC
locations cannot facilitate this), clinical parameters will not be measured in
the NDC-only/app-only group.

After the NDC-program has ended (September 2019), the subjects assigned to the
NDC+app-group will continue to use the eHealth app for 10 more weeks to assess
the added value of the app for maintenance of behaviour change. The
NDC-only-group will not have any intervention during these 10 weeks of
follow-up. The NDC-only/app-only group will be enrolled in the study at the end
of the NDC-program and start using the application from this time onwards
during the 10 weeks follow-up period. This group will consist of participants
of the NDC that did not use the IRIS app during the NDC challenge. The results
of this group will be used to assess the added value of the app for maintenance
of behaviour change, independent of active NDC participation.
This group will be compared to the NDC-only group (to assess the beneficial
effects on an application during follow-up), as well as the NDC+app group (to
assess whether the usage period of the application affects compliance and
maintenance of behaviour change).

Cohort data from a comparable population with T2DM will be used as a control
group. For this purpose, data from the "DIAbetes and LifEstyle Cohort Twente"
(DIALECT) will be used, which is a T2DM cohort running from the ZGT (hospital
group Twente) in the Netherlands (Gant et al., 2017; Jalving et al., 2018).
From this cohort lifestyle behaviour (physical activity via SQUASH
questionnaire and dietary intake via FFQ), clinical parameters (HbA1c, glucose,
lipid profile), anthropometry (weight, waist circumference, BMI) and
demographic data (age, gender, SES, etc.) can be extracted. These cohort data
reflect care as usual in people with T2DM. As for this cohort no quality of
life data are available, the participating health care centres (NDC locations)
will be asked to distribute the link to an online quality of life questionnaire
to their patients that are not participating in the NDC program. These data can
then serve as a control situation for the psychosocial parameters.

Subjects in the study groups (NDC-only, NDC+app, and NDC-only/app-only) will
take part in the NDC intervention program, a 20-week community-based walking
event in which weekly group walks are organized under professional guidance of
a health care provider or local sports coach. This intervention program will
start in May 2019 and end with a (facultative) festival day end of September in
the Hague. Subjects are recruited amongst people that already signed up to
participate in the NDC-program.

The NDC+app and the NDC-only/app-only group will, on top off the weekly walks
organized by the NDC, get access to the IRIS-app. This is a Smartphone
application developed by TNO for personalized systems-based lifestyle support
for people with type 2 diabetes.
The app includes functionality to:
* Assess current health status, using the main T2D-related health markers
(glucose, in-sulin, body weight, BMI) as well as medication use;
* Generate a personalized recommendation for lifestyle (e.g. a dietary
pattern). Sub-jects may be recommended one or more of these dietary pattern
based on their T2DM pathophysiology and medication use. If more than one
dietary pattern is rec-ommended, the subject can choose which diet fits their
preferences;
* Assess current food and diet related habits;
* Advice the user in achieving the recommended lifestyle, tuned to the
individual health data and current dietary behaviour of the user;
* Set personal lifestyle goals as first step towards achieving a healthy diet
* Monitor the achievements in lifestyle change;
* Notifications for reminding the participants of entering their data (reaching
goals, moti-vation, self-efficacy, mood);
* Provide support via evidence-based behaviour change interventions, including
motiva-tion enhancement, planning interventions and relapse prevention
detection.
Subjects in the NDC+app group are asked to use this smartphone application
during the Na-tional Diabetes Challenge program, as well as during the
follow-up period (October -December 2019).
Subjects in the NDC-only/app-only group will be asked to start using this
smartphone applica-tion at the end of the NDC-program, thus during the
follow-up period only (October-December 2019).
Use of the application will cost participants maximum a few minutes per day,
mostly for self-monitoring their personal goals.

In this study, people with type 2 diabetes are included. All of the subjects
will participate in the NDC-program, which means they will be physically
active. Half of the study population will also get lifestyle advice via an app.
By changing their lifestyle, people with type 2 diabetes could improve their
diabetes-related health markers, including glucose and insulin. If changes in
these parameters occur, changes in medication might also be necessary. This
risk is mitigated by the involvement of the GP and/or GPA of the patient in the
program, which can closely monitor the health status of the patients.
Additionally, the intensity of the lifestyle interventions is not very high,
due to the focus on long-term behaviour change and empowerment, and thus no
very extreme or sudden changes in biomarkers are expected.
For subjects that undergo blood withdrawal, there is a small risk for bruises.