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

Phase

N/A

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Tourette's Syndrome

Obesity

Treatment

Treatment in the Meta Care Clinic

Standard care with general practitioner and/or outpatient clinics

Clinical Study ID

NCT06624462

The Meta Care Clinic

2096-00099B

p-2023-14342

H-23045618

Ages 18-45
All Genders

Study Summary

This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with schizophrenia spectrum disorders (International classification ofdiseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)
Medical treatment with antipsychotics
Age 18-45 years
Legally competent
Able to give informed consent

and either:

Body mass index (BMI) ≥30 kg/m2.

BMI ≥27 kg/m2 and at least one of the following:
Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6months
Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevatedlow-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months
Sleep apnoea (ICD-10 DG473).
Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose asdefined by the International Diabetes Federation within the previous 6 months.

a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.

Exclusion

Exclusion Criteria:

Clinical or laboratory evidence of comorbid medical disease not compatible withparticipation as judged by the research team.
Unstable psychiatric disorder as judged by the research team.
Severe current drug or alcohol misuse as judged by the research team.
Acute suicidal risk.

Study Design

Treatment in the Meta Care Clinic

October 10, 2023

December 31, 2026

Study Description

Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism caused by antipsychotic medication comprise modifiable risk factors, which remain undertreated.

The investigators will address the gaps in cardiometabolic care of SMI patients by examining the effectiveness of a pragmatic metabolic care clinic for patients with SMI. Moreover, the investigators will include qualitative investigation of patients' perspectives in relation to acceptability, satisfaction with care, and motivation for health behaviour change.

A total of 84 patients between 18-45 years with diagnoses of schizophrenia spectrum disorders or bipolar disorder will be recruited from inpatient and outpatient clinics in the Mental Health Services of the Capital Region of Denmark. Eligible patients are antipsychotics-treated and present with a 5% weight increase / 5 cm waistline increase since initiation of antipsychotic therapy or body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 and concomitant prediabetes, diabetes, hypertension, sleep apnoea and/or dyslipidaemia.

Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 1:1 to a pragmatic, specialized metabolic clinic with measurement-based care and evidence-based best-practice treatment or standard care. The primary outcome is the proportion of patients in the intervention group achieving a weight loss ≥5% of initial body weight vs the standard care group at 12 months. Secondary and exploratory outcomes include changes in other cardiovascular risk factors, quality of life, personal recovery and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.

Connect with a study center

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Glostrup, Capital Region 2600
Denmark
Site Not Available
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Glostrup Municipality 2621356, Capital Region 6418538 2600
Denmark
Active - Recruiting

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