Integrating Digital Innovation in Weight Management: Assessing the Acceptability, Clinical and Cost-Effectiveness of Roczen - A Real-World Evidence Study

Question: Can a new digital weight management model of care (Roczen) improve health service delivery and address the Quintuple Aim of Healthcare (health outcomes, cost, patient and clinician experience, and health inequalities), for individuals living with obesity accessing Tier 3 weight-management services? Background: Twenty-six percent of UK adults live with obesity and 37.9% are overweight. This creates profound healthcare challenges, with annual NHS costs of £6.5bn, > 1 million hospital admissions, and £63bn societal costs. Obesity is a chronic, relapsing, progressive disease; a major risk factor for metabolic diseases (type-2 diabetes, cardiovascular disease) and poor mental health. Interventions include multi component behavioural interventions, pharmacotherapy, and bariatric surgery. However, access is limited: only 60% regions in England have multidisciplinary specialist obesity services (Tier 3), and where services exist, most clinically eligible individuals are not referred. Waiting lists are >12 months; during which time obesity-related conditions worsen, increasing burden on GPs and emergency departments. Digital health interventions are a promised solution and a NICE priority. However, evidence is needed around efficacy to reduce BMI sustainably, free-up access to specialist obesity care to those of greatest need, and reduce inequalities in obesity-related health outcomes. Aims: To evaluate effectiveness of Roczen, a clinician-led digital health intervention, in the highly-diverse population of South-East London: Determine clinical- and cost-effectiveness of digital Tier 3 weight management (Roczen) when offered as an alternative to Tier 3 patients on NHS waitlists. Determine clinical-/cost-effectiveness of Roczen for one-year following traditional Tier 3 interventions vs standard care (discharge to GP). Determine feasibility and acceptability (patients and clinicians) of integrating Roczen as a supportive digital weight management model of care within existing pathways. Identify predictors of success/retention for future weight management evidence-generation studies, including consideration of weight stigma. Methods: Three studies: Roczen as alternative to standard care: clinical intervention study with quasi-controls (standard Tier 3 pathways at Guy s and St Thomas ) to establish at least equivalent efficacy of Roczen to standard care. Sub-groups include use of GLP-1s, comorbidities, social demographics. Methods include multilevel mixed-effects linear regression. Outcomes are clinical effectiveness (% weight loss), cost-effectiveness (EQ5D), service utilisation and patient questionnaires (WBIS, DEQ, PHQ-2). Roczen for maintenance of weight loss after Tier 3 Discharge: clinical intervention study with quasi-controls, with active cohort opting for Roczen on discharge; control not opting for Roczen and accessing standard primary care. Methods and outcomes follow study 1, with predictive analytics to predict participant selection choices. Process Evaluation: Qualitative study to determine acceptability/feasibility of implementing Roczen into Tier 3. Methods include semi-structured interviews (with PPI co-facilitators), with inductive thematic analysis. Timelines: The 36-month project enables data collection across patients at baseline, 3, 6, 12, 18 and 24 months. Impact: Impact is anticipated on patients (access, waiting lists, equity, mental health, quality-of-life), Tier 3 (waiting lists, single points of access, cost-effectiveness), primary care (post-discharge provision, reduced avoidable appointments), growth (R&D jobs, revenues), and academia (generalisable learnings, PhD studentships, training). Dissemination to participants includes newsletters/social media; to NHS/stakeholders it includes conferences, publications, demonstrations and distribution partnerships.