Clinical Research Directory

Peel Family Diabetes Prevention Program

Sponsor: Trillium Health Partners

Summary

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 (the 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 the study participants. Study's SA and BAC participants 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 who has children aged 25 or under living in the same household. If the Family caregiver has youth children aged 14 to 25 years residing in the same household, who want to participate in the study, they are welcome to join it but not mandatory. The study aims to generate preliminary evidence on both the implementation and effectiveness of the intervention over a six-month per person period. The overall duration of the study (implementation, effectiveness monitoring an evaluation) will be up to 16 months, from the the start of recruitment in May 2026 to the September 2027, where the intervention delivery for the last participant enrolled in the study will expected to be completed. Family caregiver participants of each ethno-cultural 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-month post-randomization time point. 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, social media, referral pathways, academics, researchers, and decision-makers.

Official title: Peel Family Diabetes Prevention Program (Peel FDPP): Family-Centred Health and Wellness Coaching Pilot Randomized Controlled Trial

Key Details

Conditions

Interventions

Locations (2)