The aim of the current proposal is to compare the (cost)effectiveness of a 12-month multidimensional lifestyle approach for SMI outpatients to usual care to reduce cardiometabolic risk factors in SMI patients. Secondary research questions include…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lifestyle issues
Synonym
Health condition
overgewicht, hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is waist circumference.
Secondary outcome
Secondary outcomes include obesity/cardiometabolic risk (BMI, blood pressure,
plasma triglycerides, cholesterol (LDL, HDL, and total cholesterol), fasting
glucose and HbA1c), psychological outcomes (depressive symptoms, negative
symptoms), outcomes for cost-effectiveness (quality of life, care consumption,
registration of medication) and behavioural/environmental determinants of
intervention success in both patients and nurses (like readiness to change,
attitude). The somatic measurements including lab tests and most questionnaires
are part of standard Routine Outcome Monitoring. Other information is collected
using questionnaires. Measurements are taken at baseline, after 6 and after 12
months. For intervention participants, a small somatic assessment (BMI, waist
cirucmference, blood pressure) is taken at 3 and 9 months to provide feedback
on lifestyle changes.
Background summary
Patients with severe mental illness (SMI) have an increased cardiometabolic
risk and the prevalence of type 2 diabetes is up to four times higher than in
the general population of comparable age. Although monitoring the somatic
health of SMI patients is now obligatory in The Netherlands, most comorbidities
are left untreated due to a lack of knowledge, and fear that medication will
interact with antipsychotic medication. Lifestyle intervention in high risk
individuals from the general population has been shown to be (cost-) effective,
and even more effective than early pharmacological treatment, to prevent type 2
diabetes and reduce cardiometabolic risk. This non-pharmacological intervention
to reduce cardiometabolic risk may also be effective in SMI patients.
Study objective
The aim of the current proposal is to compare the (cost)effectiveness of a
12-month multidimensional lifestyle approach for SMI outpatients to usual care
to reduce cardiometabolic risk factors in SMI patients. Secondary research
questions include whether the intervention decreases depressive and negative
symptoms and whether the multidimensional lifestyle approach is cost-effective.
Study design
Single blind clustered randomized controlled trial using a pragmatic design
(http://www.bmj.com/content/340/bmj.c1066) to improve external validity.
This research is Health Technology Assessment research, in the category *early
evaluation of promising care strategies*, this means the evaluation of new
interventions that have been proven effective on other settings or patients
groups.
Intervention
The 12-month intervention consists of biweekly 15-minute sessions. The
self-management tool is based on e-health and is developed as the Traffic Light
website (www.leefstijlinbeeld.nl). It is developed in and for the Dutch GGZ
population. Several steps guide patient and nurse to better lifestyle habits.
First, the Traffic Light method displays a risk profile with all lifestyle
behaviors in green, orange or red, depending on the level of risk. Second, the
patient decides which behavior he/she wants to change. The nurses use
motivational interviewing (MI) techniques and the stages of change model to
assist the patient in this process. Third, the Traffic Light is used to create
a lifestyle plan. The nurse*s role is to support patients in setting and
achieving realistic goals. Finally, the Traffic Light model is used to sustain
change using behavioural techniques.
Study burden and risks
The burden is low. Both the somatic and psychological aspects of the
ROM-screening are part of routine care. One additional ROM-screening (at 6
months) is foreseen. Additional information is collected using questionnaires.
The program will be part of regular care visits of the nurse with the patient,
so no extra sessions are needed. Increasing risk awareness during the
counselling is combined with the possibility to take action, reducing distress
due to risk awareness alone. No adverse side effects of the measurements or
program are foreseen.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Included patients have at least one of the following risk factors:
- waist circumference > 102 cm (male) or > 88 cm (female);
- fasting glucose > 5.6 mmol/l; or HbA1c > 5.7 %
- BMI > 25 kg/m2.
- patient participates in yearly ROM-screening (routine screening for somatic and mental health)
Exclusion criteria
Exclusion criteria:
- pregnancy;
- BMI < 19 kg/m2
- physical impairments that make daily physical activity impossible
- patients with primary diagnosis of Korsakov syndrome
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44565.042.13 |