Actively Recruiting
Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Led by Bjorn H. Ebdrup · Updated on 2026-01-08
84
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Bjorn H. Ebdrup
Lead Sponsor
G
Glostrup University Hospital, Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a pragmatic metabolic care clinic designed for patients with severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder. Patients with SMI face high mortality rates linked to cardiovascular disease, often worsened by obesity and metabolic issues caused by antipsychotic medications. The study seeks to improve cardiometabolic care by comparing specialized metabolic clinic treatment against standard care and also includes patient interviews to understand satisfaction and motivation. Participants will be randomly assigned to one of two groups: one receiving 12 months of treatment in the metabolic care clinic, which includes medical consultations, lifestyle interventions, medication evaluations, and coordinated care with specialists; the other group will continue standard care through their psychiatric outpatient clinic or general practitioner. Measurements and monitoring occur at enrollment, 6 months, and 12 months for the clinic group, and at enrollment and 12 months for the standard care group. Throughout the study, patients will undergo regular assessments including weight, waist circumference, blood pressure, cholesterol, glucose, and other cardiovascular risk factors. The primary outcome measures the proportion of patients achieving at least 5% weight loss after 12 months. Secondary outcomes assess broader metabolic and health indicators, quality of life, and cognitive function. Interviews will also explore patient experiences and factors influencing health behavior changes during the trial.
CONDITIONS
Brief Title
Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with schizophrenia spectrum disorders (ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)
- Currently treated with antipsychotic medication
- Age between 18 and 45 years
- Legally competent and able to provide informed consent
- Body mass index (BMI) of 30 kg/m2 or higher
- Or BMI of 27 kg/m2 or higher with at least one of the following: hypertension, dyslipidaemia, sleep apnoea, prediabetes, or diabetes
- Or history of rapid weight gain of 5% body weight or 5 cm waist circumference increase since starting antipsychotic therapy
You will not qualify if you...
- Presence of other medical diseases that make participation unsuitable
- Unstable psychiatric condition as judged by the research team
- Severe current misuse of drugs or alcohol
- Acute risk of suicide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive treatment in a specialized metabolic clinic with consultations, lifestyle interventions, pharmacotherapy, and management of cardiovascular risk factors, or continue with standard care involving their general practitioner and/or outpatient clinics.
3 visits for treatment group (at enrollment, 6 months, and 12 months) and 2 visits for standard care group (at enrollment and 12 months)
Duration - Short period after 12 months
Qualitative interviews are conducted post-intervention to explore patient experience and contextual factors related to acceptability, satisfaction, and motivation for health behaviour change.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Glostrup Municipality, Capital Region, Denmark, 2600
Actively Recruiting
Research Team
B
Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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