Obesity in individuals with serious mental illness Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet the following study eligibility criteria: 1. Are adults aged =18 years 2. Have a clinically confirmed primary diagnosis of SMI, including schizophrenia or bipolar disorder (ICD F20-39) 3. Have a BMI of >30kg/m2 at baseline (adjusted to =27.5 for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean backgrounds, in line with NICE guidance) 4. Have a clinically diagnosed condition of diabetes (type 1 or type 2), hypertension, or both 5. Have reliable access to the internet via a smartphone, tablet, laptop, or desktop computer 6. Is registered with a GP practice that is open for recruitment 7. Is considered appropriate by the participant’s GP practice for enrolment in this study and referral to the NHS DWMP at the time of invitation
Exclusion criteria
Exclusion criteria: 1. Previous bariatric surgery 2. Have a history of or a current clinically confirmed diagnosis of an eating disorder 3. People who are pregnant, planning pregnancy, breastfeeding, or planning to breastfeed 4. Have a clinically confirmed recent myocardial infarction or stroke in the past three months or uncontrolled cardiac conduction abnormalities (e.g., long QT syndrome, maculopathy or proliferative retinopathy) 5. Have a clinically confirmed significant life-limiting illness that would mean weight management is unlikely to improve health (severe cardiac failure, palliatively treated cancer, dementia) or a planned major surgery that would make enrolment in a weight management programme improbable 6. Taking part in other research that would compromise their participation in the study 7. Unable to understand spoken and written English, as the core NHS Digital Weight Management (DWMP) is delivered in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility - Recruitment: measured using the total number of participants recruited per month at the end of the study;Feasibility - Retention: measured using the proportion of enrolled participants completing the follow-up assessment (%) at 14 weeks after baseline;Feasibility - Engagement (with the NHS DWMP): measured using the mean number of modules completed (out of 12) at 14 weeks after baseline;Feasibility - Engagement (with the link worker): measured using the mean number of sessions completed (out of 12) at 14 weeks after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability: measured using semi-structured interviews with participants, link workers, and recruiting primary care clinicians at 14 weeks after baseline;Exploratory changes in clinical outcomes: measured using weight (kg), Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Scale-7 (GAD-7), Positive and Negative Symptoms Scale (PANSS), Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the EuroQol 5 Dimension 5 Level questionnaire (EQ-5D-5L) at 14 weeks after baseline | — |
Countries
England, United Kingdom