Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic

Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months.

The metabolic composite score consisting of minimally 0 points and maximally five points (one point per composite; elevated waist circumference, elevated triglycerides, blood pressure, fasting plasma glucose, and reduced high-density lipoprotein), according to the definition and cut-off values of metabolic syndrome by the International Diabetes Federation. A higher score means worse outcomes. Effect measurements: differences in percentage achieving reduction of ≥1 points between groups at 12 months.

Cardiovascular risk factors as defined below.

Proportion of patients in the intervention group achieving a weight loss of ≥10% of initial body weight vs the standard care group at 12 months.

Proportion of patients in the intervention group achieving a ≥50% reduction of initial low-density lipoprotein cholesterol vs the standard care group at 12 months.

Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months.

Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months.

Changes in body mass index (BMI) where weight and height will be combined to report BMI in kg/m^2. Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months.

Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months.

The homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measured using fasting plasma glucose and fasting plasma insulin.

Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.

Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months.

Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months.

Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months.

Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months.

Cardiorespiratory fitness assessed by the submaximal Ekblom-Bak test on a mechanically braked cycle ergometer. Effect measurements: differences in mean changes between groups at 12 months.

Total body fat percentage measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.

Visceral adipose tissue measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.

Skeletal muscle mass measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.

The Brief INSPIRE Measure of Staff Support for Personal Recovery. Effect measurements: differences in mean changes between groups at 12 months.

The Questionnaire about the Process of Recovery (QPR). Effect measurements: differences in mean changes between groups at 12 months.

The World Health Organization (WHO)-5 Well-being index. Effect measurements: differences in mean changes between groups at 12 months.

The Symbol Digit Modalities Test (SDMT). Effect measurements: differences in mean changes between groups at 12 months.

The Brief Cognitive Assessment Tool in Schizophrenia (B-CATS) comprised of the following:

• The Trail Making Test.
• The Letter-Number Span Record Form.
• The Category Fluency Test.

Effect measurements: differences in mean changes between groups at 12 months.

Smoking cessation amongst persons who are smoking at baseline measured as self-reported cessation for the past 7 days after 12 months. Effect measurements: differences in mean changes between groups at 12 months.

Physical activity of weekly self-perceived volumes of different intensities and average daily sedentary hours measured with the International Physical Activity Questionnaire. Effect measurements: differences in mean changes between groups at 12 months

Appetite measured with a digital visual analogue scale (VAS) before the first meal at date of baseline measurements and date of measurements after 12 months as minimum 1 and maximally 10 with higher outcomes depicting more appetite. Effect measurements: differences in mean changes between groups at 12 months.

Semi-structured interviews will be conducted following the intervention with patients, who dropped out or completed the intervention, respectively. Patients who complete the intervention will be sampled purposefully to ensure maximum variation in terms of gender, age, and diagnosis, whereas the investigators will interview every patient dropping out (i.e., convenience sampling). Interviews will focus on satisfaction with the delivered care, and sustained motivation for health behaviour change. Data will be analysed by means of inductive-deductive thematic analysis informed by the COM-B model identifying capability, opportunity, and motivation as key factors which need to change in order for a behaviour change intervention to be effective. Adequate sample size for the qualitative evaluation will be guided by information power (also denoted saturation).