Effectiveness of a Pragmatic Metabolic Care Clinic for Patients with Severe Mental Illness: Protocol for the Randomized Controlled Meta-Care Trial

IntroductionSevere mental illness is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism associated with antipsychotic treatment comprise modifiable risk factors, which remain undertreated. Interventions such as antipsychotic-switching, lifestyle-interventions and weight-reducing medication have shown varying results indicating a need for a more individualized approach. The Meta-Care Trial aims to assess the effectiveness of a pragmatic, individualized, evidence- and guideline-based cardiometabolic intervention. Methods and analysisMeta-Care is an open-label randomized controlled trial (RCT). Patients between 18-45 years with schizophrenia spectrum disorders or bipolar disorder will be recruited from in- and outpatient Mental Health Services in the Capital Region of Denmark. Inclusion criteria include treatment with antipsychotics and: either i) [≥]5% body weight gain or [≥]5cm waist circumference increase since initiation of antipsychotic therapy, or ii) a body mass index (BMI) [≥]30 kg/m2, or iii) BMI [≥]27 kg/m2 and related cardiovascular risk factors. Patients are randomized to a pragmatic, individualized metabolic clinic using evidence- and guideline-based care in a mental health center or standard care. Allocation-ratio is 1:1. The primary outcome is the proportion of patients achieving weight loss [≥]5% of initial body weight after 12 months. Secondary and exploratory outcomes cover cardiometabolic risk factors, cognition, personal recovery, and quality of life. Qualitative interviews will explore patient experience and contextual factors. Recruitment started in October 2023 and will include a total of 84 patients. Ethics and disseminationThe Meta-Care trial is funded by The Independent Research Fund Denmark and The Worzner Memorial Fund for Research in Mental Illness. The trial has been approved by the Regional Ethics Committee and Data Protection Agency in the Capital Region of Denmark. Positive, negative, and inconclusive results will be published in scientific peer-reviewed journals, presented at conferences, and dispersed to patient organisations and media. Strengths and limitations- The Meta-Care Trial is the first randomized control trial (RCT) to investigate the effectiveness and acceptability of a pragmatic, individualized metabolic clinic located in a mental health center using evidence- and guideline-based care to treat obesity and cardiometabolic risk factors in patients with severe mental illness - The pragmatic design with limited exclusion criteria and simple outcome measures will generate results that are generalizable to clinical practice - The complex Meta-Care multi-intervention limits inferences of effects explained by specific modifications of pharmacotherapy or lifestyle changes - Potential knowledge exchange from treating personnel in the Meta-Care Trial to caregivers in the standard care group may lead to contamination bias - Although the Meta-Care trial has an open label design, measurements of primary and secondary outcomes will be carried out by blinded assessors