Family-based wellness coaching to prevent type 2 diabetes in Peel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial tests a community-based health coaching intervention delivered to primary family caregivers and optional youth living in the same household, with the aim of reducing type 2 diabetes risk and improving related health outcomes. The study uses a Hybrid Type 2 design to examine both effectiveness and implementation in real-world community settings. Participants are recruited through Peel-based organizations and followed for six months after randomization, with mixed-methods data to inform future scaling and adaptation. The intervention consists of family dyad health and wellness coaching sessions and educational materials, with outcomes including biomarkers, anthropometrics, well-being, knowledge, health behaviors, and family-level effects. The trial targets 70 South Asian and 70 Black African/Caribbean caregiver participants, with optional youth involvement.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Ian Zenlea, MD, MPH — Institute for Better Health, Trillium Health Partners, Mississauga.
• Study coordinator: Cilia Mejia-Lancheros (Study Research Lead), RN, MPH, Msc. GHP, PhD
• Email: Cilia.Mejia-Lancheros@thp.ca
• Phone: 437 216 6209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.