Class 2 obesity (BMI =35 kg/m²) with at least one medical complication (e.g., prediabetes, type 2 diabetes [T2DM])
Conditions
Interventions
W8Buddy is a virtual specialist WMS pathway. It is accessed through a digital behavioural change platform called the Gro Health app. Participants will either use (i) a fully digital weight management
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and above 2. Class 2 obesity (BMI =35 kg/m²) with at least one medical complication (e.g., prediabetes, type 2 diabetes [T2DM]); or patients with obesity class 3 (BMI =40 kg/m²), without any complications.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Type 1 diabetes mellitus 3. End-stage renal disease (eGFR <15, receiving renal replacement therapy) 4. Active or untreated alcohol or drug dependency 5. Decompensated liver disease 6. History of anorexia, undergoing treatment or awaiting treatment for DSM-V classified eating disorder 7. Severe mental health disease, including acute mental health crisis or self-harm in the last 12 months 8. Unstable mental health disease, including unstable personality disorder, schizophrenia and bipolar disorder 9. Unwilling or unable to commit to participation across the length of the research study 10. Patients targeting bariatric surgery within the length of the research study 11. Participating in another weight management research intervention 12. Participating in the diabetes remission program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured using specialist scales provided as part of the digital pathway or specialist scales used in NHS sites as part of standard of care at baseline and months 6, 12, 18 and 24, with reporting at month 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost-effectiveness of W8Buddy measured using validated tools recommended by a health economist at baseline and months 6, 12, 18 and 24, with reporting at month 18 2. The Impact of W8Buddy on multiple long-term conditions associated with obesity, measured using mixed methods approaches including surveys and interviews at baseline and months 6, 12, 18 and 24, with reporting at month 18 3. Implementation and use of W8Buddy within Weight Management Services (WMS), measured using mixed methods approaches including surveys and interviews at baseline and months 6, 12, 18 and 24, with reporting at month 18 4. Manual for safe incorporation of a digital pathway delivering weight loss medication into existing WMS across the UK, created using mixed methods approaches, including surveys and interviews throughout the duration of the study 5. Recommendations for how we can optimise the existing infrastructure of WMS to improve ongoing RWE generation, created using mixed methods approaches, including surveys and interviews throughout the duration of the study | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactRichard Green
Outcome results
None listed