Diabetes and WELLbeing the Netherlands 2

Diabetes is a long term non-communicable disease with high costs to patients,
health services and society, and for which there is currently no standardised
approach to self-management. Diabetes is an increasing problem, even more so it
is starting to become an worldwide epidemic. This emphasizes that type 2
diabetes is an ever increasing problem, and this has led to a cross-border
initiative (United Kingdom, Belgium, France and the Netherlands) under the name
of the DWELL project (Diabetes WELLbeing).
An overall aim has been set, that every country will use to set up their own
mono-centre intervention, of which all data will be combined when the study is
completed. Data analyses will then be performed on the data derived from each
country.
This research protocol will therefore be restricted to the Amphia hospital, the
centre of interest for the Netherlands.

Healthy diet, regular physical activity, and maintaining a normal body weight
are ways to prevent or delay the onset of diabetes type 2. Based on this fact,
it seems necessary to evaluate physical (in)activity in diabetes patients.
Physical inactivity has been identified as the fourth leading risk factor for
global mortality, meaning extreme sedentary behaviour can actually be deadly.
This emphasizes the importance of physical activity in the entire health care
system. In the DWELL project physical activity levels will be identified using
the International Physical Activity Questionnaire (IPAQ). This is questionnaire
designed to investigate people*s activity levels.

Motivational interviewing is a directive, patient-centred form of counselling
designed to evoke changes in behaviour by assisting people to explore, clarify
and resolve ambivalence regarding behaviour change. Using motivational
interviewing the advantages and disadvantages of the current and intended
behaviour can be identified, thereby motivating the patient to take control of
the situation and identify barriers that keep the patient from changing his
behaviour. From this point onwards, the patient will be assisted in setting
realistic goals regarding behaviour change, which can be used to increase
intrinsic-motivation, which will ultimately positively affect lifestyle changes
long term. Previous studies have shown controverting results towards the effect
of motivational interviewing, and it appears the frequency, intensity and
timing of the sessions are of great importance for its effect.

In conclusion, we believe it is in the best interest of diabetes patients
worldwide to create a holistic innovative treatment programme, which involves a
combination of lifestyle interventions such as monitoring physical activity and
offering motivational interviewing, to create the most personal and specified
support for patients, that could increase the success-rate of self-management.

A relationship can be identified between HbA1c levels and self-management and
quality of life. It appears better self-management skills result in a larger
improvement of HbA1c levels, and the other way around, getting control over
HbA1c levels is a necessity to be able to effectively manage and control
diabetes. Therefore, HbA1c levels could be used as an objective parameter to
identify whether physical activity coaching and motivational interviewing leads
to increased self-management skills. Furthermore, improved HbA1c levels seem to
correlate with an improved quality of life. The main objective of this study is
to investigate changes in HbA1c levels of type 2 diabetes patients, as a result
of an intervention involving motivational interviewing and a combined lifestyle
intervention.

The study will be set up as a randomized controlled trial, consisting of 3
groups, one control group that will receive standard care and two intervention
groups. It has been chosen to make the control group slightly smaller, to be
able to receive significant results, but at the same time provide as many
participants as possible with the intervention. The participants of both
intervention groups will be given a personalized combination of lifestyle
interventions based on the IPAQ. The participants in one of the intervention
groups will receive motivational interviews (for 12 weeks) in addition to the
personalized combination of lifestyle interventions. The appointment to each
group will be blinded as CASTOR will be used to randomly assign participants to
either of the groups. A long-term check-up will be performed after 9- and 15
months, which falls in line with usual care check-ups.

Patients in the intervention groups, will be asked to fill in the IPAQ
questionnaire, as a means of getting information on physical activity.
Participants will be asked to fill out this questionnaire at baseline, after
the 12-week intervention, and at 9- and 15-month follow-up. The questionnaires,
Short Form Health Survey (SF-12), Nederlandse Vragenlijst voor eetgewoonten
(NVE), European Quality of Life (EQ5D) and brief version of the Illness
Perception Questionnaire (IPQ-BR), Diabetes Empowerment Scale-Short Form
(DES-SF), will be conducted at baseline, at the end of the 12 week intervention
and at 9- and 15 months follow-up as well. Blood values are measured as form of
standard care, and will be analysed for this study as well.

The motivational interviewing will be used as an extra form of support in the
process to decreasing HbA1c in one of the intervention groups. Motivational
interviews will be conducted more frequently, namely 2 to 8 times in the
12-week intervention period. The first meeting will take place in the first
week, the second meeting will be initiated by the patients themselves. During
this meeting it will be estimated how many meetings are desirable based on the
individual needs and characteristics of the patient. By complying to the
patient*s needs, the motivational interviewing will increase motivation and
coherence to treatment. Its effect will be measured through the change in HbA1c
levels.

Patients in the control group will receive the standard diabetes care, and will
be asked to complete all questionnaires, IPAQ, SF-12, NVE, EQ5D, IPQ-BR, DES-SF
at baseline, after the 12 week intervention period and at 9-, and 15 months
follow-up and their bloodwork will be analyzed as well. The quality of care
questionnaire will be completed after 12 weeks intervention period.

It is the aim of the DWELL project to involve patients in the development of
several modules that can be added to the intervention. Building on that, the
DWELL project is hoping to get some motivated participants and train them to
become patient ambassadors. They will then receive training as well and will
become a factor of support for new patients. Since they have been through the
process themselves, it is expected that these patient ambassadors have a better
understanding of the patients and will be able to provide support from
experience and create group relatedness, which can be beneficial for both old
and new patients. The old patients will form a beacon of information and
support for the new patients, whereas the new patients will provide a constant
flow of motivation for the old patients.

All tests will be performed by educated and specifically trained personnel in
controlled environments, using standardised protocols that guarantee patient
safety. Therefore, it is expected that significant risks will not occur.
In addition, a risk classification has been performed, using the NFU risk
classification list and table. Based on these tables, it is safe to conclude
that the participants in this study are at no risk.