Peel Family Diabetes Prevention Program
Recruiting · NCT07675551 · Interventional (participants receive a specific treatment) · Lead sponsor: Trillium Health Partners
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Dyad participants will consist of a self-identified primary family caregiver aged 18 years or older and a youth family member aged 14 to 24 years at the time of study entry. The primary family caregiver will serve as the primary (index) research participant for the dyad and should have the following inclusion criteria:
- Self-identifies as either South Asian or Black, African and Caribbean.
- Lives in the Peel Region (Mississauga, Brampton or Caledon), Ontario, Canada.
- Be 18 years or older and have a youth child aged 14 to 24 years in the household who is willing and consents to participate. AND
- Have no medical diagnosis (self-reported) of diabetes.
- Have no medical diagnosis (self-reported) of prediabetes that requires any medical or pharmacological treatment.
- Have a blood-based sugar greater than or equal to 6.5 measured through the hemoglobin A1c test using a finger prick at the pre-enrollment assessment visit. AND
- The family dyad (family caregiver and youth) must be proficient in English (reading, writing, and speaking), as English will be the primary language used for the participation eligibility, implementation, delivery, and evaluation of the intervention.
Exclusion criteria
- for family dyad:
- Do not meet all the criteria above.
- A medical condition or health professional has advised them not to engage in physical activity of any type, or they are following a specific diet.
- Cannot give informed consent to participate voluntarily in the intervention and study.
Where it is running
2 locations listed.
- Wellfort Community Health Services - Brampton, Ontario, Canada
- Punjabi Community Health Services (PCHS) - Brampton, Ontario, Canada