Topic: Mental Health Research Network
Conditions
Interventions
NICE recommended usual care: An annual physical health review as per the NICE guidelines. Verbal & printed advice on the risk of weight gain & lifestyle advice, including information about diet, exerc
Sponsors
Sheffield Health and Social Care NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old. There is no upper age limit. 2. Clinical diagnosis of schizophrenia (defined by Internal Classification of Diseases (ICD-10) codes F20 - Schizophrenia and F25 - Schizoaffective disorders)) including first episode psychosis using case note review. There is no limit on the duration of illness 3. Patients must have been treated with an antipsychotic. For those with established schizophrenia, the treatment duration should be at least 1 month prior to the start of the trial. 4. Ability to give written informed consent 5. Ability and willingness to attend and participate in a group education programme 6. Ability to speak and read English 7. Body mass index 25 kg/m2 or concerned about weight gain since treatment initiation. For patients from South Asian and other Black and Minority Ethnic backgrounds, the BMI threshold will be reduced to 23 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Physical illnesses that could seriously reduce their life expectancy or ability to participate in the trial 2. A co-existing physical health problem that would, in the opinion of the medical investigators, independently impact on metabolic measures. 3. Mental illnesses that could seriously reduce their ability to participant in the trial 4. Current pregnancy, plus mothers less than 6 months post-partum. Conditions associated with significant weight gain e.g. Cushing's syndrome 5. Significant alcohol or substance misuse 6. A diagnosis or tentative diagnosis of psychotic depression or mania 7. A primary diagnosis of learning disability 8. Already engaged in a systematic weight management programme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (kg) at 12 months after randomisation; Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adapted Brief Illness Perception Questionnaire; Timepoint(s): 3 and 12 months 2. Adapted Dietary Instrument for Nutrition Education; Timepoint(s): 3 and 12 months 3. Adverse events; Timepoint(s): 3 and 12 months 4. Blood pressure; Timepoint(s): 3 and 12 months 5. Body Mass Index; Timepoint(s): 3 and 12 months 6. Brief Psychiatric Rating Scale; Timepoint(s): 3 and 12 months 7. Changes in medication; Timepoint(s): 3 and 12 months 8. Client Service Receipt Inventory; Timepoint(s): 3 and 12 months 9. EQ-5D 5L; Timepoint(s): 3 and 12 months 10. Fasting glucose, lipid profile and glycated haemoglobin (HbA1c); Timepoint(s): 12 months 11. Patient Health Questionnaire 9 (PHQ-9); Timepoint(s): 3 and 12 months 12. RAND SF36; Timepoint(s): 3 and 12 months 13. Smoking status; Timepoint(s): 3 and 12 months 14. Waist circumference; Timepoint(s): 3 and 12 months 15. Weight; the proportion who maintained or reduced weight; percentage change in weight; Timepoint(s): 3 and 12 months 16. Wrist worn accelerometry (7-day GeneActiv); Timepoint(s): 3 and 12 months | — |
Countries
United Kingdom
Outcome results
None listed