Protocol for the implementation and evaluation of a context-adapted diabetes prevention program: Small Steps for Big Changes (SSBC) – Australia (Preprint)

BACKGROUND With type 2 diabetes rates escalating worldwide, effective, acceptable and sustainable diabetes prevention programs are needed. Small Steps for Big Changes (SSBC) is a Canadian-developed and community-delivered diet and exercise counselling intervention for individuals at risk of type 2 diabetes. The 3-6 week intervention is deliverable by non-health professionals, with all SSBC coaches receiving training in delivery of the program, including motivational interviewing. Funding has been obtained to adapt, implement and evaluate the SSBC program in Australia. OBJECTIVE This protocol describes the process of adapting the SSBC program to an Australian delivery context (SSBC Australia), including the novel use of pre-professional graduate and undergraduate students from a range of programs as coaches. It also details the protocol for the type 2 cluster non-randomised single-arm hybrid effectiveness-implementation trial of the program in Australian community sites. METHODS A multiphase process will be used to adapt and deliver SSBC in Australia, including an exploratory phase to understand site needs and adaptations required (completed) followed by a delivery phase. The integrated PRISM (Practical, Robust, Implementation Sustainability Model) and RE-AIM (Reach, Adoption, Effectiveness, Implementation, Maintenance) framework, and the APEASE (Affordability, Practicality, Effectiveness and cost-effectiveness, Acceptability, Side-effects/safety, and Equity) criteria will guide the implementation and evaluation of these phases and inform iterative adaptations as required. SSBC Australia will be delivered and evaluated in five community-based sites across two organisations in South-East Queensland, Australia. One organisation (one site) will trial training students on clinical and project placements to act as coaches. The recruitment target is 500 participants completing the six-session intervention across the five sites within two years, and approximately 50 coaches trained. Data will be collected from the organisation, provider site, coach, and client using a variety of methods (surveys, objective assessments, qualitative interviews, site audits, website analytics, meeting minutes, project tracking). Data will be collected on the: context for delivery; adoption and reach (number of coaches and clients and their characteristics); effectiveness of the coach training and the intervention (client pre-post changes in measured clinical indicators [body composition, cardiorespiratory fitness, strength, balance], and self-reported health behaviours [movement behaviours; healthy eating; program behaviours], psychosocial indicators [self-efficacy; social supports], quality of life, diabetes status, health care utilisation); implementation of the coach training and program delivery (fidelity; acceptability); and, maintenance of program delivery (sites) and client outcomes at 3-, 6- and 12-months post end-of-program. RESULTS Trial ethics has been obtained, and the five sites are recruited. Resources have been iteratively adapted and pilot tested for the Australian delivery context, including for student delivery. The trial will start in mid-2025. CONCLUSIONS This study will provide evidence whether the culturally-adapted SSBC diabetes prevention program can be successfully implemented and is effective within an Australian context. CLINICALTRIAL This trial has been registered with the Australian and New Zealand Clinical Trials Network ACTRN12624001194550 (registered prospectively on 30th September, 2024; last update 27th April 2025).