Research into the shorter and longer term effects of two low-intensity exercise programs in people with type 2 diabetes mellitus (T2DM)

The National Diabetes Challenge (NDC) has already proven to be able to mobilize
the vulnerable group of people with diabetes, who often have a lower
socio-economic position. Previous research into the effects of the NDC has
shown that the NDC contributes to an improvement in quality of life, with a
lower BMI, waist circumference, blood pressure, medication use and HbA1c. More
evidence is needed that the NDC delivers (health) benefits, especially when it
comes to longer-term effects.
With the arrival of the GALA, control over prevention has fallen to the
municipalities. When this is implemented through the NDC, municipalities want
to see that this results in a better quality of life and more self-reliance
among vulnerable participants. The results of the research project will be used
in accountability to the municipalities. (Co-)financing from municipalities is
necessary to be able to offer the NDC structurally and on a larger scale
throughout the Netherlands. The need for structural financing is growing,
because referring participants then comes 'between the ears' of healthcare
providers and can become part of their work. For exercise and wellness
professionals, the NDC will then be included annually in the implementation
plans and they can continue to expand and consolidate the local network and
collaboration.
In addition, if the results are favorable, the research will contribute to
recognition of the intervention by the Healthy Living Desk/RIVM, with the
desire to move to the *Effective* level. This increases the chance of a
conversation with other municipalities and assurance of the NDC. But it also
keeps the options open to grow from recognition to a Combined Lifestyle
Intervention. Insurers and municipalities have jointly made agreements in the
Integrated Care Agreement (IZA) and Regional Images whereby the chances of the
NDC increase if there is good scientifically substantiated research on the
impact of the challenge.

The most common outcome measures that participating parties and financiers have
focus on the following main themes:
- Are there sufficient somatic changes, such as an increase in the number of
steps per day, changes in weight, changes in blood pressure and changes in
glucose regulation and medication use? We have been able to demonstrate these
types of changes (reports available), although not all data has been published.
- Are there changes in mental and social factors that indicate an improvement
in well-being, quality of life, self-efficacy in terms of feeling more
responsible for the management of one's own diabetes? We have also studied
that, but here too the results have not all been published.
- How long does the effect of the intervention last? In any case, we were able
to see an effect up to and including a year and a half (unpublished data)
- Is this intervention cost-effective? Of course, that largely depends on how
you define cost-effectiveness. If you look from a Social Return on Investment
(SROI) perspective, every euro invested ultimately yields ¤ 4.55 (report
available)

For research into these themes, research that has already been conducted is
partly repeated, combining previously researched aspects, supplemented with
linking data from participants to the CBS data and in-depth analysis
(continuous glucose monitoring) with a subgroup of participants. For the most
relevant outcomes, participants are followed for up to two years after the
start of the intervention. Many of today's financiers want to know what the
longer-term effects are. In addition, it provides the opportunity to see
whether the DIB (50 weeks) is more effective than the NDC (20 weeks). The
proposed plan, as described below, is based on this.

see also above

The aim of the project is to investigate the effects of an accessible 20- and
50-week walking intervention for people with diabetes. This examines the level
of physical activity, quality of life, patient activation, diabetes
self-management, somatic health, medication use and glucose metabolism.

The research questions that are answered are:
• What is the effect of participation in the NDC and Diabetes in Movement on
the level of physical activity, measured in the number of steps taken per day,
in the period before the intervention, during the intervention, and 1 year and
2 years after the start of the intervention?
• What is the effect of participation in the NDC or Diabetes in Motion on
glucose regulation, comparing the baseline data with the data halfway and at
the end of the intervention?
• What is the effect of participation in the National Diabetes Challenge and
Diabetes in Motion on the quality of life and (diabetes) self-management,
medication and weight 20 weeks, 1 year and 2 years after the start of the
intervention?

This is a prospective cohort study among people with diabetes who participate
in the NDC (20 weeks) or Diabetes in Motion (50 weeks) in 2024 with four
measurement moments (T0 - T3). Participants will be followed for 2 years after
the start of the intervention.
People that subscribed to one of the walking interventions are invited to
participate in the study. All people who show interest in participation in
either the NDC of the DiB will when they are enrolled for the challenges
(estimate of expected participants in 2024 over 3,000 persons) receive a
message to confirm their participation. In this confirmation message they will
be asked whether they are interested in participation of the study as presented
now. Those individuals who show interest will receive the subject information
sheet of the study (*patient informatie brief*), and when they agree to
participate included in the study (consent form) provided with more detailed
information.

All participants in the NDC 2024 will receive a digital invitation to
participate in the study before the start of the 20-week walking intervention
in April. This will take place in September for participants in Diabetes in
Motion (50-week intervention). If participants have given permission to
participate, they will be asked for permission to link with CBS data.
Participants receive online questionnaires by email. These questions relate to
quality of life, patient activation and diabetes management. These
questionnaires are sent again after 20 weeks (T1), 1 year (T2) and 2 years
(T3). This group is referred to as group A in the outcome measures.

In a subgroup of 60 participants (30 NDC, 30 DIB) with T2DM, the number of
steps and blood glucose levels are also mapped. Prior to the intervention, they
receive an activity tracker (Garmin VivoFit 4) to keep track of the daily
number of steps. For three weeks, participants wear a glucose sensor (FreeStyle
Libre 2), which measures the glucose concentration every minute. For the entire
subgroup, the first contact will have to take place well before the start of
the walking intervention, in order to also take baseline measurements of both
glucose metabolism and exercise pattern. This group is referred to as group B
in the outcome measures.

A number of efforts are required on the part of the participants, such as
helping to make the generated data accessible (Vivofit and FSL2) and completing
the questionnaires repeatedly.
There are no risks associated with any of these interventions, except for the
very small chance that a subcutaneous vessel will be punctured when inserting
the FSL2 probe.