After the Health Check in vulnerable groups: an individually tailored self regulation intervention led by Community Health Workers.

With the vast rise of individuals with chronic conditions, the focus of our
health care system will shift from cure to prevention by identifying people at
high risk for cardiovascular disease (CVD), Diabetes Mellitus type II (DM II),
and kidney disease. Especially non-Western immigrant groups are at (very) high
risk for these chronic diseases. It is well established however, that
identifying high risk individuals by health checks in primary care only to a
limited extent reach those high risk groups from deprived neighborhoods. In
above-mentioned study (ABR nr. 37141) our research group will develop tools to
increase participation in health checks in individuals from non-Western
immigrant populations. However, increasing participation with health checks is
only a first step towards illness prevention for migrant populations. Effective
follow-up interventions are necessary to ensure that they will really benefit
from the health check information by changing unhealthy lifestyle behaviors.
The current study focuses on how high risk individuals with a non-Western
background are motivated to start and maintain a healthy lifestyle.

Changing behavioral patterns that have become habitual is complex. Evidence
shows that simple health education interventions like just providing lifestyle
advice by general practitioners yield little or no effects, especially when
behavior maintenance is considered. Previous reports have criticized
self-management interventions for applying a *one-size-fits-all approach*
without relating them to individuals* needs and personal goals.

Community Health Workers (CHWs) who have expertise in motivational interviewing
techniques may improve uptake, maintenance, adherence, and self-control in our
patients. CHWs facilitate social support, community education, access and
adherence to preventive / rehabilitation care
and monitoring of risk, adherence to treatment recommendations, promotion of
self-care skills, and other follow-up care.

In the Netherlands, there are no CHWs yet. Health professionals matching the
CHW most closely are (migrant) lifestyle coaches of existing lifestyle programs
like *Exercise on prescription*. Also, the general practitioners* practice
nurse often has received specific training for the role we propose for the CHW.
For this study, these different professionals will receive specific
(additional) training to be able to perform the role of CHW.

Key elements in a strategy to reach sustainable behavioral changes are among
others: personal, longstanding guidance, feasible goals, tailored and repeated
advices, tuning at the patients* own beliefs and possibilities. Based on our
knowledge of the literature, an approach with CHWs helping high risk
individuals to restructure their environment and to set and keep attainable
health goals seems promising.

The overall objective of this study is to increase the uptake and maintenance
of healthy behaviors among adults from non-Western immigrant populations who
are identified as having a high risk of cardiometabolic disease after
completing a health check. This will be achieved by developing and testing an
individually tailored self-regulation intervention provided by a trained CHW.

The study has a stepped approach in which (1) we will carefully develop a
self-regulation intervention for the follow-up care for high risk individuals
of non-Western immigrant populations by applying an intervention mapping
protocol to build a sound foundation and by locating relevant existing
interventions that can be integrated in the program; (2) the effectiveness of
the intervention will be evaluated by conducting a randomized controlled trial
(RCT); (3) the evaluation of phase 1 and 2 will result in a set of
recommendations for successful implementation of a strategy to support high
risk individuals of the target population in starting and maintaining a healthy
lifestyle.

Research questions are the following:
1. Which factors play a key role in the uptake and maintenance of behavioral
changes in high risk groups for cardiometabolic disease according to (high
risk) individuals from non-Western immigrant populations and health
professionals? (Earlier approved under P11.030)
2. Which tailored theory-based interventions for self-management of
cardiometabolic disease exist (in the Netherlands and in foreign countries)?
3. Is a tailored CHW-led self-regulation intervention for the target group
superior as compared to usual care?
4. Which recommendations can be given for implementing strategies for an
adequate follow-up after a high risk identification by a health check
assessment to change risky lifestyle behaviors on the short and long term?

Stratified randomized controlled trial and process evaluation.

The self-regulation intervention will consist of a self-regulation protocol for
guidance of high risk individuals from non-Western immigrant populations. This
self-regulation intervention will be pretested. Individuals from the study
population with a
high risk of cardiometabolic problems will be referred to a CHW. The CHW will
analyze the personal circumstances and behavioral factors of the patients,
develop a personalized self-regulation program, and follow-up maintenance of
behavior change. The focus of this pretest is on testing procedures and gaining
feedback on the process by the patient, CHW, and other health professionals.
The self-regulation intervention will be pretested in two general practices, in
the setting of the Foundation Prevention and Care (Stichting Preventie en
Curatie) in The Hague . Two CHWs will be trained. These trained CHWs will both
manage three patients. The training will be evaluated, activities will be
registered and CHW, general practitioner, practice nurse, and patients will be
interviewed. One contact of each CHW will be observed. After the pretest the
self-regulation intervention or the guiding protocol will be adapted if
necessary.

For the intervention, patients from the study population will be randomly
assigned to the intervention (n=150) or control group (n=150). The intervention
group will receive a prevention consultation at the general practitioner
followed by a self-regulation intervention guided by a trained CHW. The control
group will only receive the prevention consult at the general practitioner and
be advised according to *usual care* standards. Stratification will be
effectuated to include individuals of all three vulnerable groups (Turkish,
Moroccan, and Surinamese immigrant groups).

For the outline of the interventionprogram, see p.8 of the protocol.

Outcome criteria will be measured 3 times in both the intervention and the
control group: at the start of the prevention consultation at the general
practitioner, directly after the intervention period and 3 months after the
intervention period.

The baseline measurement consists of the completed health risk assessment prior
to the prevention consultation at the general practitioner. During the
prevention consultation blood pressure, weight and length, hip and waist
circumference are measured, blood samples are obtained for glucose, total and
HDL cholesterol, and patients fill out the questionnaire on psychosocial
determinants of health behaviors. The questionnaire is estimated to take
approximately 30 minutes.

Directly after the intervention period and 3 months after the intervention
period the participants will complete the health risk assessment and the
questionnaire on psychosocial determinants of health behaviors.

Three months after the intervention period, blood pressure and blood samples
will be obtained during a visit at the general practitioner / assistant nurse.