Peel Family Diabetes Prevention Program

Background: Communities from South Asian (SA) and Black African and Caribbean (BAC)backgrounds in the Peel region of Ontario, Canada, experience disproportionately highrates of type 2 diabetes (T2D). The high prevalence of T2D in these communities is drivenby a complex set of interrelated factors, including biological predisposition,environmental, and social/behavioural influences, all of which are shaped by socialdeterminants at the societal, system, area, and individual levels. Based on existingcollaborative research conducted in these populations in Peel, as well as input fromdiverse community partners and Peel organizations serving SA and BAC communities, thereis 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 preventionmodel and support scale‐up in larger implementation and effectiveness studies.Methods: In partnership with local Peel‐based community organizations, the research teamwill recruit 70 SA family dyads and 70 BAC family dyads to participate in a Hybrid Type 2Effectiveness‐Implementation Pilot Randomized Controlled Trial (RCT) with a 12‐monthperson‐level follow‐up post‐randomization and a mixed‐methods approach. Of the 70participating dyads in each community group, 70 will be randomly allocated (1:1) to theintervention group and 70 to the control group. The overall study duration will be 24months, spanning from participant recruitment through to completion of primaryimplementation and effectiveness outcome reporting.Family dyad participants in the intervention group will receive tailored, human‐deliveredhealth and wellness coaching for the T2D prevention program over 12 months, delivered intwo main stages. Stage 1 (0‐6 months post randomization): Dyad participants will receivebiweekly diabetes‐focused coaching sessions, supplemented by a monthly group‐basedcoaching session. The intervention group will also receive a co‐designed educationalbooklet on diabetes prevention and a weekly short motivational coaching reminder (viaemail or text, depending on participant preferences). Stage 2 (6‐12 months): Aftercompleting Stage 1, dyad participants will receive at least one coaching session and willcontinue to receive monthly brief motivational reminders. At the end of the 12‐monthfollow‐up, participants will complete the study through a coaching closeout assessmentsession conducted by the team coaches.The control dyad group will receive the same co‐designed diabetes prevention booklet asthe intervention group but will not receive additional coaching support during the12‐month follow‐up period. At the end of the follow‐up period, control participants willconclude their participation in the study by completing a survey‐based assessment of T2Dgoal 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 throughsemi‐structured qualitative interviews conducted by research staff, supplemented withbrief survey‐based measures. Reach will be assessed from baseline through the recruitmentperiod, 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 oflife. 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 physicalactivity, sleep duration, quality, satisfaction, and environmental influencing factors;mental well‐being state; perceived stress; resilience; and family functioning. Tertiaryoutcomes will include the intervention's impact on family well‐being. Objective measures(biomarkers, blood pressure, body weight, and adiposity) will be collected in person byresearch staff at enrolment (T1), 6 months (T2), and 12 months (T2). All remainingoutcomes will be assessed using self‐administered surveys with validated scales,structured questions, and qualitative open questions at baseline (T1), 6 months (T2), and12 months (T3) from the randomization date.The investigators will use a mixed‐methods, cross‐sectional and longitudinalconvergence‐analytical approach to integrate quantitative and qualitative data and, whenpossible, identify areas of convergence, complementarity, or divergence acrossimplementation and effectiveness outcomes. Primary effectiveness outcomes will beanalyzed using an intention‐to‐treat approach, accounting for repeated measures,interdependence within dyads when applicable, and variation in person‐time follow‐up. Theinvestigators will estimate and report observed effect sizes, along with theircorresponding 95% confidence intervals, for all outcomes using mixed‐effects models orGeneralized Estimating Equations, as appropriate. Secondary analyses will further explorepotential complex, interrelated associations between implementation and effectivenessoutcomes, as well as the influence of socio‐demographic and other factors on theserelationships. For qualitative data, the investigators will apply a QualitativeLongitudinal Research approach to analyze repeated qualitative data collected for bothimplementation and effectiveness components. Finally, the investigators will conduct amixed‐methods analysis, integrating findings from both qualitative and quantitativestrands to assess their alignment, divergence, or complementarity.Findings: Both implementation and effectiveness findings will be reported, contributingimportant evidence on the delivery and impact of the piloted health and wellness coachingintervention for T2D prevention among SA and BAC family dyads. These findings will helpassess refinements to the intervention model and implementation approach and providepreliminary estimates of potential impact across primary, secondary, and tertiaryindicators. Investigators will also assess whether the proposed theory of change issupported, specifically whether the intervention contributes to reducing T2D risk andimproving quality of life by supporting participant‐ and family‐tailored diabetesprevention goals, and whether it influences intermediate drivers of T2D risk.Conclusion: The findings and methodological approach of the pilot‐tested proposedintervention will guide the design of larger‐scale implementation and effectivenessstudies across the same or different communities and settings to further assess its realimpact on reducing T2D risk and the main driving factors associated with it.