The goal of this Hybrid Type 2 effectiveness-implementation pilot randomized controlled trial is to assess the feasibility and preliminary effectiveness of a community-based wellness coaching intervention to prevent type 2 diabetes (T2D) among South Asian (SA) and Black African and Caribbean (BAC) communities in the Peel region of Ontario, Canada. The study evaluates the impact of the intervention on reducing diabetes risk and related intermediate outcomes, including biomarkers, anthropometric measures, well-being, knowledge, health behaviours, and family-level outcomes in participating family dyads. Each SA and BAC family dyad will consist of a primary adult family caregiver aged 18 years or older, who does not have T2D and is not taking pharmacological treatment for blood glucose reduction, and a youth aged 14 to 24 years residing in the same household. The study aims to generate preliminary evidence on both the implementation and effectiveness of the intervention over a 12-month period. Participant dyads of each ethnocultural group (SA and BAC) will be randomly assigned to either the intervention or control arm. During the first six months, participants in the intervention arm will receive biweekly health and wellness coaching delivered by trained community-based coaches, optional group coaching sessions with other participants, weekly motivational messages, and an educational T2D prevention booklet. Participants in the control arm will receive only the educational T2D prevention booklet. Implementation and effectiveness outcomes will be assessed using a mixed-methods approach, integrating qualitative and quantitative data collected at baseline and at the 6- and 12-month post-randomization time points. This approach is intended to generate comprehensive, preliminary evidence on both the implementation and effectiveness components of the health and wellness intervention. Quantitative and mixed-methods analyses will be conducted to provide an integrated understanding of the implementation and effectiveness outcomes studied. Findings from this pilot trial will inform the design of larger, definitive studies to better assess impact and guide future escalation and/or adaptation. Results will be disseminated in multiple formats and tailored to diverse audiences, including community partners, local communities, academics, researchers, and decision-makers.
Age range
14 Years
Sex
ALL
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Implementation Outcome: Intervention Acceptability
Timeframe: Six months post-randomization and twelve months post-randomization
Implementation Outcome: Intervention Appropriateness
Timeframe: Six months post-randomization and twelve months post-randomization
Implementation Outcome: Intervention Reach
Timeframe: Baseline
Implementation Outcome: Intervention Adoption (Uptake)
Timeframe: Six months post-randomization and twelve months post-randomization
Implementation Outcome: Intervention Availability
Timeframe: Six months post-randomization and twelve months post-randomization
Implementation Outcome: Intervention Fidelity
Timeframe: Six months post-randomization, and twelve months post-randomization
Effectiveness Outcome: T2D Risk
Timeframe: Baseline, six months post-randomization and twelve months post-randomization
Cilia Mejia-Lancheros (Study Research Lead), RN, MPH, Msc. GHP, PhD
Effectiveness Outcome: Overall Quality of Life
Timeframe: Baseline, six months post-randomization, and twelve months post-randomization
Effectiveness Outcome: Health-Related Quality of Life
Timeframe: Baseline, six months post-randomization, and twelve months post-randomization
Effectiveness Outcome: Health-attached QoL Meaning and Perceptions
Timeframe: Baseline, six months post-randomization, and twelve months post-randomization
Effectiveness Outcome: Happiness
Timeframe: Baseline, six months post-randomization, twelve months post-randomization
Effectiveness Outcome: Happiness Meaning and Perceptions
Timeframe: Baseline, six months post-randomization, and twelve months post-randomization