Salutogenic Intervention for Diabetes Type 2: the SALUD-study

Type 2 diabetes is one of the most common chronic diseases worldwide with an
enormous impact on quality of life, micro and macrovascular complications, life
expectancy and economy. Type 2 diabetes is a typical nutritional- and
lifestyle-related disease, but it is often approached pharmacologically. There
are many glucose-lowering agents on the market. For a long term, it has been
thought that type 2 diabetes was not reversible. However, recent intervention
studies have shown that type 2 diabetes is preventable in 50% of the cases and
that the disease is reversible by a (strict) healthy diet. It appears to be
difficult for people to adhere to strict healthy diets as very few lifestyle
intervention studies for type 2 diabetes had a lasting beneficial effect on the
eating behaviour and health.

An important cause for this may be that the lifestyle interventions so far take
had limited attention for the complexity of everyday life in which people with
type 2 diabetes have to navigate dietary changes in everyday life. A
theoretical framework that pays particular attention to daily life is
salutogenesis. Salutogenesis focuses on the factors that create and enhance
health. At an individual level this is for example dealing with stress, and at
a social level receiving support from friends or family. Previous research
shows that people prefer to participate in interventions that make life worth
living rather than interventions that are solely focused on dealing with the
illness. The evidence base of health effects of salutogenic interventions for
various diseases is also growing in the last few years.

Therefore, this study used salutogenesis for the development of the
SALUD-intervention program. SALUD stands for 'SALUtogenic intervention for
Diabetes type 2'. *Salud* is also the Spanish word for *health*. The
development of the SALUD-program consisted of several (quantitative and
qualitative) studies about the opinions and preferences of diabetes patients
and caregivers. This resulted in an intervention that aims to support people
with type 2 diabetes to eat healthier in the everyday life. The
SALUD-intervention consists of multiple components. The core components are the
developing of self-identity and social support. Additional components include
goal setting, stress management, and nutritional knowledge and skills. The
current study is needed to investigate whether the SALUD-intervention has a
beneficial effect on healthy eating and health of people with type 2 diabetes.

The aim of this study is to determine the effects of the SALUD-intervention on
food literacy (a measure of food-related knowledge and skills)

Randomized, blinded controlled trial (two-armed)

The SALUD-intervention differs from the standard diabetes care by its holistic,
salutogenic and practical approach to healthy eating in daily life. It is a
program consisting of 12 weekly online group sessions. The groups consist of
6-8 diabetes patients and professional lifestyle coach that guides the
sessions. A dietician will also be present at some meetings.

The SALUD-program consists of several components. The core components are
developing of self-identity and social support. Additional components include
goal setting, stress management, and nutritional knowledge and skills. During
the online-group sessions, participants are supported in setting and achieving
personal health goals. Every session, participants reflect on their goals and
share experiences with each other. In addition, every session has its own theme
(e.g. building confidence or stress). One session is "open", which means that
the participants can choose the theme of this session according to their needs
at that time. The last session is a festive celebration in which the
participants reflect on their experiences during the intervention. Three months
after this session, there is a booster day to meet again and share experiences.

The control group receives the usual care for type 2 diabetes (conform to the
Dutch NHG protocols). The researchers will make separate appointments with the
participants for the measurements.

Measurements are performed at baseline, 12 and 24 weeks and are conducted at
the participant's homes.

After completion of the third measurement (at 24 weeks), the SALUD programme is
offered to the participants of the control group without any obligation.
Participants who choose to follow the programme still undergo a fourth
measurement.

Participation in the SALUD-study does not pose major risks to the health or
safety of participants since the study does not test a medical product or
dictates behavioural rules. Instead, the SALUD-intervention recommends a
healthy diet (based on the Dutch nutritional guidelines 2015) and supports
people in implementing healthy eating practices in their daily lives.

The burden consists of completing questionnaires and the time investment (the
time investment differs between the intervention and control group).

A burden is filling in the questionnaires. It takes about 60-90 minutes at a
time to complete all questionnaires. In addition, the questionnaires regarding
psycho-social health (self-efficacy, quality of life and sense of coherence)
can possibly cause negative feelings. To reduce the risk of this, participants
will be given a clear explanation of the purpose of the questionnaires. In
addition, the researchers will monitor the subjects mental well-being during
the study and contact a healthcare provider if they have concerns about the
subjects' well-being during the study.

Te time investment is approximately 30 hours (over 24 weeks) for the
participants in the intervention group. The participants will be well informed
about this and it will be explained that the participants can stop at any time,
without having to give a specific reason. We expect that most participants will
experience participating in the SALUD-program as enjoyable, because the
SALUD-program will be tailored to individual wishes and needs. It is also
possible that the participants will experience health benefits and improved
quality of life during the SALUD-program. The SALUD-program was developed on
the principle 'learning by doing' and there was also attention during
development to make the intervention fun and informal.

The time investment is considerably smaller for the control group
(approximately 4-6 hours over 24 weeks). They will follow the standard care
for type 2 diabetes. The time investment mainly consists of the measurements.
For the participants in the control group, the discomfort will be relieved as
much as possible by providing good explanations about the study/the procedures
and making the measurements as easy as possible for the participants (e.g.
measurements are performed at the participant's home). In addition, the SALUD
programme will still be offered to the participants of the control group after
the completion of the third measurement moment.

At the end of the study, all participants will be informed about the study
insights and results. All participants receive a reward of 150 euro after
completion of the study.