Background: Communities from South Asian (SA) and Black African and Caribbean (BAC) backgrounds in the Peel region of Ontario, Canada, experience disproportionately high rates of type 2 diabetes (T2D). The high prevalence of T2D in these communities is driven by a complex set of interrelated factors, including biological predisposition, environmental, and social/behavioural influences, all of which are shaped by social determinants at the societal, system, area, and individual levels. Based on existing collaborative research conducted in these populations in Peel, as well as input from diverse community partners and Peel organizations serving SA and BAC communities, there is a clear need for more family-focused programming to prevent T2D in these communities, particularly community-led and culturally sensitive approaches.
Objective: To assess the intervention's preliminary implementation and effectiveness. Findings will inform future adaptation of the health and wellness coaching T2D prevention model and support scale-up in larger implementation and effectiveness studies.
Methods: In partnership with local Peel-based community organizations, the research team will recruit 70 SA family dyads and 70 BAC family dyads to participate in a Hybrid Type 2 Effectiveness-Implementation Pilot Randomized Controlled Trial (RCT) with a 12-month person-level follow-up post-randomization and a mixed-methods approach. Of the 70 participating dyads in each community group, 70 will be randomly allocated (1:1) to the intervention group and 70 to the control group. The overall study duration will be 24 months, spanning from participant recruitment through to completion of primary implementation and effectiveness outcome reporting.
Family dyad participants in the intervention group will receive tailored, human-delivered health and wellness coaching for the T2D prevention program over 12 months, delivered in two main stages. Stage 1 (0-6 months post randomization): Dyad participants will receive biweekly diabetes-focused coaching sessions, supplemented by a monthly group-based coaching session. The intervention group will also receive a co-designed educational booklet on diabetes prevention and a weekly short motivational coaching reminder (via email or text, depending on participant preferences). Stage 2 (6-12 months): After completing Stage 1, dyad participants will receive at least one coaching session and will continue to receive monthly brief motivational reminders. At the end of the 12-month follow-up, participants will complete the study through a coaching closeout assessment session conducted by the team coaches.
The control dyad group will receive the same co-designed diabetes prevention booklet as the intervention group but will not receive additional coaching support during the 12-month follow-up period. At the end of the follow-up period, control participants will conclude their participation in the study by completing a survey-based assessment of T2D goal attainment, administered by research team staff.
Primary co-implementation outcomes will include acceptability, appropriateness, reach, adoption (uptake), availability, and fidelity. These outcomes will be assessed through semi-structured qualitative interviews conducted by research staff, supplemented with brief survey-based measures. Reach will be assessed from baseline through the recruitment period, while all other outcomes will be measured at 6 and 12 months post-randomization.
Co-effectiveness primary outcomes will include hemoglobin A1c (HbA1c) and quality of life. Secondary outcomes will include goal-achievement progress, diabetes knowledge, biomarkers (lipid panel), blood pressure, body weight and adiposity, dietary behaviours, cooking practices, diet-related self-efficacy, healthy food intake patterns, and physical activity, sleep duration, quality, satisfaction, and environmental influencing factors; mental well-being state; perceived stress; resilience; and family functioning. Tertiary outcomes will include the intervention's impact on family well-being. Objective measures (biomarkers, blood pressure, body weight, and adiposity) will be collected in person by research staff at enrolment (T1), 6 months (T2), and 12 months (T2). All remaining outcomes will be assessed using self-administered surveys with validated scales, structured questions, and qualitative open questions at baseline (T1), 6 months (T2), and 12 months (T3) from the randomization date.
The investigators will use a mixed-methods, cross-sectional and longitudinal convergence-analytical approach to integrate quantitative and qualitative data and, when possible, identify areas of convergence, complementarity, or divergence across implementation and effectiveness outcomes. Primary effectiveness outcomes will be analyzed using an intention-to-treat approach, accounting for repeated measures, interdependence within dyads when applicable, and variation in person-time follow-up. The investigators will estimate and report observed effect sizes, along with their corresponding 95% confidence intervals, for all outcomes using mixed-effects models or Generalized Estimating Equations, as appropriate. Secondary analyses will further explore potential complex, interrelated associations between implementation and effectiveness outcomes, as well as the influence of socio-demographic and other factors on these relationships. For qualitative data, the investigators will apply a Qualitative Longitudinal Research approach to analyze repeated qualitative data collected for both implementation and effectiveness components. Finally, the investigators will conduct a mixed-methods analysis, integrating findings from both qualitative and quantitative strands to assess their alignment, divergence, or complementarity.
Findings: Both implementation and effectiveness findings will be reported, contributing important evidence on the delivery and impact of the piloted health and wellness coaching intervention for T2D prevention among SA and BAC family dyads. These findings will help assess refinements to the intervention model and implementation approach and provide preliminary estimates of potential impact across primary, secondary, and tertiary indicators. Investigators will also assess whether the proposed theory of change is supported, specifically whether the intervention contributes to reducing T2D risk and improving quality of life by supporting participant- and family-tailored diabetes prevention goals, and whether it influences intermediate drivers of T2D risk.
Conclusion: The findings and methodological approach of the pilot-tested proposed intervention will guide the design of larger-scale implementation and effectiveness studies across the same or different communities and settings to further assess its real impact on reducing T2D risk and the main driving factors associated with it.