RECRUITING Not applicable ClinicalTrials.gov

Peel Family Diabetes Prevention Program

Sponsor: Trillium Health Partners • ClinicalTrials.gov ID: NCT07675551

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Family Dyad Health and Wellness Coaching Session (Behavioral)
Biweekly health and wellness coaching sessions (in-person or virtual) for type 2 diabetes, provided by trained community-based coaches. The maximum session length will be 30 minutes, with no mandatory minimum. Coaches will also share a short weekly motivational message, delivered to participants' phones or emails, depending on preferences. The intervention group participants may join an optional monthly group-based health and wellness coaching session with other program participants. Group sessions will be approximately 2 hours in length.
Educational Material (Behavioral)
A printed or digital educational booklet on type 2 diabetes (T2D) prevention. The booklet contains information related to the causes and signs of T2D, diet and physical activity engagement activities, mental well-being enhancement and stress management, strategies to set up positive lifestyles and behavioural change, along with a list of local health and social support services that may be used to further promote overall well-being and support T2D risk reduction.

Eligibility criteria

Inclusion Criteria: Study participants will consist of a self-identified primary family caregiver aged 18 years or older with children under 25 year of age living in the same household. Optional youth family member aged 14 to 25 years at the time of study entry are welcome but not mandatory. The primary family caregiver will serve as the primary (index) research participant for the study and should have the following inclusion criteria: 1. Self-identifies as either South Asian or Black, African and Caribbean. 2. Lives in the Peel Region (Mississauga, Brampton or Caledon), Ontario, Canada. 3. Be 18 years or older and have children aged 25 years or under in the same household. AND 4. Have no medical diagnosis (self-reported) of diabetes. 5. Have no medical diagnosis (self-reported) of prediabetes that requires any medical or pharmacological treatment. Have a blood-based sugar lower than or equal to 6.5 measured through the hemoglobin A1c test using a finger prick at the pre-enrollment assessment visit. AND 6. The family caregiver and optional youth (when participating) 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: 1. Do not meet all the criteria above. 2. 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. 3. Cannot give informed consent to participate voluntarily in the intervention and study.

Conditions

Diabete Type 2

Locations

Wellfort Community Health Services — Brampton, Ontario, Canada
Punjabi Community Health Services (PCHS) — Brampton, Ontario, Canada

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment