Joining forces to develop and evaluate a toolkit to promote sustained lifestyle change among overweight and obese multimorbid individuals with a combination of the chronic diseases type 2 diabetes mellitus, cardiovascular disease, and/or cancer: the Lifestyle medicine for individuals with multiple chronic diseases (LifeMeds) study

The aging population is accompanied by an increase in the prevalence of chronic
diseases like Type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD),
and cancer. These chronic diseases share similar lifestyle-related risk factors
such as overweight and obesity. The increasing coexistence of these diseases,
referred to as multimorbidity, increases the burden on healthcare providers and
healthcare costs. Sustained lifestyle changes may improve health outcomes in
individuals with multimorbidity and eventually reduce the burden on healthcare
(costs). However, a suitable approach to achieving sustained lifestyle changes
in individuals with multimorbidity is lacking. Both in prior research and in
clinical practice, the focus is typically on singular chronic diseases rather
than on multimorbidity. Additionally, little is known on how to achieve
sustained lifestyle among multimorbid individuals with a low socioeconomic
status (SES), low health literacy and/or from ethnic minorities, as they face
unique challenges. Given the complexity of the physical, and psychosocial
challenges that individuals with multimorbidity are confronted with, a tailored
approach to accomplish sustainable lifestyle changes and improve health
outcomes is warranted.

Objective 1. To conduct an extensive needs assessment on how to promote
individually tailored (sustained) lifestyle changes in individuals with
multimorbidity, including vulnerable groups and ethnic minorities.
Objective 1.1: To gain in-depth information on the most important perceived
barriers and facilitators of sustained lifestyle (change).
Objective 1.2: To gain detailed insight into the real-time interrelation and
relative importance of observed barriers and facilitators of lifestyle (change)
and how they are influenced by contextual factors (e.g. social and physical
environment).
Objective 2. To co-create a toolkit and training program for patients and
healthcare providers for the promotion of individually tailored (sustained)
lifestyle changes considering disease- and treatment-related, psychological,
and socio-demographic determinants.
Objective 3. To assess feasibility, usability and user satisfaction of the
LifeMeds toolkit.
Objective 4. To evaluate the pre-efficacy of the LifeMeds toolkit and create a
plan for the adoption, implementation, sustainability and evaluation of this
toolkit in clinical practice.

The ORBIT model will be used to guide the development and evaluation of the
toolkit. Within the first phase of the ORBIT model, to guide the development of
the toolkit, intervention mapping (IM) will be used for mapping elements of
behavioral interventions. As part of the needs assessment, a prospective
observational mixed-methods study will be executed on individuals with
overweight and multiple chronic diseases will be conducted. Approximately 16
participants will be invited to participate in in-depth interviews.
Additionally, 4 focus groups will be formed to identify perceived barriers and
facilitators of (sustained) lifestyle changes. Based on these qualitative
results, a single case design, Ecological Momentary Assessment (EMA), and
Longitudinal Real-Time Assessment (LRTA) will be used over fourteen consecutive
days with six daily EMA assessments to examine insight into the observed
barriers and facilitators of lifestyle changes at the individual level. A
mixed-methods feasibility study will be conducted to assess the feasibility,
acceptability, and usability of the LifeMeds toolkit using a single-arm
quasi-experimental pre-post design before evaluation and implementation of the
toolkit. Pre-efficacy will be evaluated with a single-case experimental design,
using a multiple baseline approach.

The risks of participation are minimal. The burden associated with
participation includes the time invested. It is important to note that
participants will be invited to participate in some of the studies described.
Participants will join either a focus group or will be interviewed.
Additionally, some of these participants and new participants will be requested
to participate in an EMA and LRTA study. During this EMA and LRTA study,
participants will wear a smartwatch/accelerometer for 14 days, complete a 3-day
food diary, and complete six daily EMA assessments using their smartphone. For
the co-creation sessions, participants will be requested to participate in 4
co-creation sessions of the development of the toolkit. Similarly, the time
investment is requested of some patients to participate in a study to assess
the feasibility of the co-created toolkit, which requires a time investment of
around 2 months to familiarize themselves with the toolkit and apply it as well
as completion of some questionnaires and a semi-structured interview. Finally,
some participants will be asked to provide a larger time investment by
evaluating the pre-efficacy of the toolkit throughout 20 weeks.