An interventional study of Treatment in the Meta Care Clinic and Standard care with general practitioner and/or outpatient clinics in Severe Mental Disorder, Metabolic Complication and Side-Effect;Medication, sponsored by Bjorn H. Ebdrup. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Bjorn H. Ebdrup · Not applicable, Interventional, and Treatment
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's planned enrollment of 84 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Bjorn H. Ebdrup is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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and either:
- Body mass index (BMI) ≥30 kg/m2.
Or
Or
- 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 Criteria:
The patients who after randomization are allocated to the treatment arm will receive 12 months of treatment in a pragmatic metabolic clinic. Patients will receive measurements/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.
Other: Treatment in the Meta Care Clinic
The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and/or contact with their general practitioner. Patients will receive measurements/monitoring upon enrolment and after 12 months.
Other: Standard care with general practitioner and/or outpatient clinics
* Consultations by medical doctors with specific metabolic training from the metabolic clinic located at Centre for Addiction and Mental Health in Toronto, Canada, and an exercise physiologist. * Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and/or general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden. * Lifestyle interventions * Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain * Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology. * Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry. * Qualitative interviews will be conducted post-intervention.
Following measurements after 12 months, patients will receive individualized lifestyle recommendations from an exercise physiologist and a MD will offer to send recommendations regarding the following potential post-trial interventions to the patients' general practitioner and/or outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology: * Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden. * Suggestions regarding potential add-on of weight reducing pharmacotherapy. * Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
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.
Time frame: 12 months
The metabolic composite score
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.
Time frame: 12 months
Cardiovascular risk factors
Cardiovascular risk factors as defined below.
Time frame: 12 months
Proportion of patients achieving a weight loss of ≥10% of initial body weight.
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.
Time frame: 12 months
Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol
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.
Time frame: 12 months
Body weight
Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Waist circumference
Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Body mass index
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.
Time frame: 12 months
Glucose
Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Insulin
Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
The homeostatic Model Assessment for Insulin Resistance
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.
Time frame: 12 months
Total cholesterol
Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Low-density lipoprotein cholesterol
Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
High-density lipoprotein cholesterol
Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Very Low-density lipoprotein cholesterol
Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Triglycerides
Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Heart rate
Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Blood pressure
Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Hemoglobin A1c
Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Cardiorespiratory fitness
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.
Time frame: 12 months
Body composition: Total body fat percentage
Total body fat percentage measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Body composition: Visceral adipose tissue
Visceral adipose tissue measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Body composition: Skeletal muscle mass.
Skeletal muscle mass measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Personal recovery - The Brief INSPIRE Measure of Staff Support for Personal Recovery.
The Brief INSPIRE Measure of Staff Support for Personal Recovery. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Personal recovery - The Questionnaire about the Process of Recovery.
The Questionnaire about the Process of Recovery (QPR). Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Quality of life - the World Health Organization-5 Well-being index.
The World Health Organization (WHO)-5 Well-being index. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Cognition - The Symbol Digit Modalities Test (SDMT).
The Symbol Digit Modalities Test (SDMT). Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Cognition - The Brief Cognitive Assessment Tool in Schizophrenia
The Brief Cognitive Assessment Tool in Schizophrenia (B-CATS) comprised of the following: 1. The Trail Making Test. 2. The Letter-Number Span Record Form. 3. The Category Fluency Test. Effect measurements: differences in mean changes between groups at 12 months.
Time frame: 12 months
Smoking Cessation
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.
Time frame: 12 months
Physical activity
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
Time frame: 12 months
Appetite
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.
Time frame: 12 months
Qualitative evaluation
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).
Time frame: Time from study start to dropout or 12 months
Plan to share: Yes — Aggregated deidentified data is expected to be available after publication upon request.
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Bjorn H. Ebdrup