Severe mental illness and metabolic syndrome Mental and Behavioural Disorders
Conditions
Interventions
The PEGASUS intervention is a therapeutic group programme for people with severe mental illness at risk of cardiovascular disease and has been co-produced by peer workers, clinicians, and most importa
a mental health peer support worker (someone who has lived experience of mental health difficulties and is using such experience in their work to support others) and a health care professional (this m
Sponsors
City, University of London
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 18/12/2025: Service users participants will: 1. Be aged 18 to 75 years 2. Have capacity to consent to participate in research 3. Currently on the caseload of mental health services in community settings or on GP/ ICS severe mental illness (SMI) list 4. Current primary diagnosis of schizophrenia-spectrum disorders (ICD-10 diagnoses F20–29) or bipolar disorder (F31) or in Early Intervention for Psychosis Services (EIPS) with formal diagnosis of psychosis (ICD-10 diagnoses of F29) or an aforementioned diagnosis. 5. If on psychotropic medication, on stable dose for 90 days (N.B. This refers specifically to either adding or changing to a new antipsychotic medication, but not applies to dosage adjustment of a pre-existing antipsychotic medication.) 6. Enhanced CVD risk as indicated by any one of: i) Obesity defined as: waist circumference over 102cm in men (or >90cm in non-white men) or over 88cm in women (or >80cm in non-white women) or BMI=25 kg/m2 (or =23 kg/m2 in non-white people) ii) Hypertension defined as: blood pressure over 130/85 mmHg or documented hypertension on medication iii) Dyslipidaemia defined as: fasting triglyceride level over 1.7mmol/l or total cholesterol =5.0 mmol/L or on medication for hyperlipidaemia (e.g. statin) or high-density lipoprotein (HDL) cholesterol level less than 0.9mmol/l (men)/1mmol/l (women) iv) Hyperglycaemia defined as: HbA1c > 37 mmol/mol (5.5%) or fasting plasma glucose level =5.6 mmol/l or documented Type-2 diabetes (T2D) 7. If on treatment for T2D, hypertension or hyperlipidaemia, on stable dose medication for at least 90 days Intervention staff: 1. Peer (support) workers and registered mental health nurses (or other healthcare professionals or practitioners with appropriate training) 2. Based at one of the participating sites/Trusts 3. Have been trained and engaged with the PEGASUS programme to deliver (co-facilitate) the PEGASUS intervention for the purposes of this study _____ Previous key inclusion criteria: Service users participants will: 1. Be aged 18 to 75 years 2. Have capacity to consent to participate in research 3. Service Involvement: 3.1 Currently on the caseload of mental health services in community settings 3.2 Or on GP/ICS severe mental illness (SMI) list 4. Diagnosis: 4.1 Current primary diagnosis of schizophrenia-spectrum disorders (ICD-10 diagnoses F20–29) 4.2 Or bipolar disorder (F31) 4.3 Or in Early Intervention for Psychosis Services (EIPS) with formal diagnosis of the above conditions 5. If on psychotropic medication, must be on a stable dose for 90 days 6. Enhanced Cardiovascular Disease (CVD) Risk as indicated by metabolic syndrome (NCEP ATP III definition), confirmed at screening by any three of the following: 6.1 Waist circumference over 102 cm (men) or 88 cm (women) 6.2 Blood pressure over 130/85 mmHg or documented hypertension on medication 6.3 Fasting triglyceride level over 1.7 mmol/l 6.4 HDL cholesterol level less than 0.9 mmol/l (men), 1 mmol/l (women) 6.5 HbA1c > 37 mmol/mol (5.5%) or documented Type-2 diabetes (T2D) and on medication 6.6 If on treatment for T2D, hypertension or hyperlipidaemia, must be on stable dose medication for at least 90 days Intervention staff: 1. Peer (support) workers and registered mental health nurses (or other healthcare professionals or practitioners with appropriate training) 2. Based at one of the five sites/Trusts 3. Have been tra
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 18/12/2025: Service users who: 1. Are currently admitted to acute psychiatric care (i.e. inpatient admission or current referral to a Crisis & Home Treatment Team) 2. Have a primary diagnosis of alcohol or substance misuse 3. Are awaiting/going through assessment with EIPS but without formal diagnosis 4. Have a diagnosis of an organic mental health disorder (e.g. dementia) 5. Are currently in receipt of a highly structured and/ or multi-goal healthy lifestyle intervention (e.g. an intervention that combines structured diet and exercise goals, or a highly structured research-based intervention such as DIAMONDS or PRIMROSE-A). Note: referral to single goal lifestyle support, as typically provided in the voluntary-sector or as online NHS advice, is considered as part of care as usual and will be assessed in both trial groups 6. Blood pressure or hyperlipidaemia managed outside of primary care 7. Type 1 diabetes Intervention staff: Peer (Support) Workers, registered mental health nurses or other healthcare professionals or practitioners who are not trained for nor delivering the PEGASUS intervention for the purposes of this study. _____ Previous key exclusion criteria: Service users who: 1. Are currently admitted to acute psychiatric care (i.e. inpatient admission or current referral to a Crisis & Home Treatment Team) 2. Have a primary diagnosis of alcohol or substance misuse 3. Are awaiting/going through assessment with EIPS but without formal diagnosis 4. Have a diagnosis of an organic mental health disorder (e.g. dementia) 5. Are currently in receipt of a highly structured and/ or multi-goal healthy lifestyle intervention (e.g. an intervention that combines structured diet and exercise goals, or a highly structured research-based intervention such as DIAMONDS or PRIMROSE-A). Note: referral to single goal lifestyle support, as typically provided in the voluntary-sector or as online NHS advice, is considered as part of care as usual and will be assessed in both trial groups 6. HbA1c > 86 mmol/mol 7. Blood pressure or hyperlipidaemia managed outside of primary care 8. Type 1 diabetes Intervention staff: Peer (Support) Workers, registered mental health nurses or other healthcare professionals or practitioners who are not trained for nor delivering the PEGASUS intervention for the purposes of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of intervention and study delivery as assessed by focus group/interviews at 3 and 6-months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant recruitment and retention rate is measured using study records at baseline, 3 months, and 6 months 2. Waist circumference is measured using tape measurement at baseline, 3 months, and 6 months 3. Hip circumference is measured using tape measurement at baseline, 3 months, and 6 months 4. Body mass index (BMI) is measured using height and weight measurements at baseline, 3 months, and 6 months 5. Triglycerides are measured using fasting blood sample at baseline, 3 months, and 6 months 6. HDL-cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 7. LDL-cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 8. Total cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 9. HbA1c is measured using blood sample at baseline, 3 months, and 6 months 10. Blood pressure is measured using automated sphygmomanometer at baseline, 3 months, and 6 months 11. Psychiatric symptoms are measured using the Modified Colorado Symptom Index at baseline, 3 months, and 6 months 12. Dietary behaviour is measured using the Dietary Instrument for Nutrition Education (DINE) adapted by IMPaCT at baseline, 3 months, and 6 months 13. Physical activity is measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) at baseline, 3 months, and 6 months 14. Tobacco, cigarette, and betel nut or paan use is measured using self-report questionnaire at baseline, 3 months, and 6 months 15. Alcohol consumption is measured using the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) at baseline, 3 months, and 6 months 16. Health-related quality of life is measured using the EQ-5D-5L at baseline, 3 months, and 6 months 17. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3 months, and 6 months 18. Self-efficacy is measured using the Generalised Self-Efficacy Scale at baseline, 3 months, and | — |
Countries
England, United Kingdom
Contacts
Public ContactBethan;Jessica Hatherall;Catchpole
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Outcome results
None listed