Evaluation of the digital diabetes prevention programme pilot: uncontrolled mixed-methods study protocol

INTRODUCTION: The prevalence of type 2 diabetes is rising steeply. National Health Service England (NHSE) is exploring the potential of a digital diabetes prevention programme (DDPP) and has commissioned a pilot with embedded evaluation. METHODS AND ANALYSIS: This study aims to determine whether, and if so, how, should NHSE implement a national DDPP, using a mixed-methods pretest and post-test design, underpinned by two theoretical frameworks: the Coventry, Aberdeen and London - Refined (CALO-RE) taxonomy of behavioural change techniques for the digital interventions and the Consolidated Framework for Implementation Research (CFIR) for implementation processes. In eight pilot areas across England, adults with non-diabetic hyperglycaemia (NDH) (glycated haemoglobin (HbA1c) 42–47 mmol/mol or fasting plasma glucose 5.5–6.9 mmol/L) and adults without NDH who are overweight (body mass index (BMI) >25 kg/m(2)) or obese (BMI >30 kg/m(2)) will be referred to one of five digitally delivered diabetes prevention interventions. The primary outcomes are reduction in HbA1c and weight (for people with NDH) and reduction in weight (for people who are overweight or obese) at 12 months. Secondary outcomes include use of the intervention, satisfaction, physical activity, patient activation and resources needed for successful implementation. Quantitative data will be collected at baseline, 6 months and 12 months by the digital intervention providers. Qualitative data will be collected through semistructured interviews with commissioners, providers, healthcare professionals and patients. Quantitative data will be analysed descriptively and using generalised linear models to determine whether changes in outcomes are associated with demographic and intervention factors. Qualitative data will be analysed using framework analysis, with data pertaining to implementation mapped onto the CFIR. ETHICS AND DISSEMINATION: The study has received ethical approval from the Public Health England Ethics and Research Governance Group (reference R&D 324). Dissemination will include a report to NHSE to inform future policy and publication in peer-reviewed journals.