Recruiting

Wellness Coaching

Sponsor:

Trillium Health Partners

Code:

NCT07675551

Conditions

Diabete Type 2

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

Family Dyad Health and Wellness Coaching Session

Educational Material

Study Details

Brief 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.

Conditions

Diabete Type 2

Study ID

NCT07675551

Start date

May 20, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Diabetes-Prevention Health and Wellness Coaching

Family caregiver participants (family carrgiver plus optional youth) will take part in an active health and wellness coaching program type 2 diabetes (T2D) prevention, delivered over six-month. Participants will receive 1) biweekly health and wellness coaching sessions (in-person or virtual) provided by trained community-based coaches (maximum session length will be 30 minutes); 2) Receive a short weekly "motivational message" which will be delivered to their phone or email; 3) Join optional monthly group-based health and wellness coaching sessions with other program participants (session length will be 2 hours); and 4) Receive an educational booklet for T2D prevention.

active comparator: Diabetes-Prevention Booklet

Participants (family caregivers plus optional youth) will receive the same educational type 2 diabetes (T2D) prevention booklets as the Diabetes-Prevention Health and Wellness Coaching group. Participants from the Diabetes-Prevention Booklet group will be asked to use the T2D educational booklet at their own pace, set up their own T2D prevention goals, and independently access available health promotion, diabetes prevention, and social support services listed in the workbook throughout the 12-month study period.

The Diabetes-Prevention Booklet group will not receive coaching sessions, motivational messages, group-based coaching sessions, or any additional diabetes-related guidance from the study's intervention coaches or research team.

Interventions

Family Dyad Health and Wellness Coaching Session

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

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.

Primary outcome measure

  • Implementation Outcome: Intervention Acceptability [ Time Frame: Six months post-randomization. ]
  • Implementation Outcome: Intervention Appropriateness [ Time Frame: Six months post-randomization. ]
  • Implementation Outcome: Intervention Reach [ Time Frame: Baseline. ]
  • Implementation Outcome: Intervention Adoption (Uptake) [ Time Frame: Six months post-randomization. ]
  • Implementation Outcome: Intervention Availability [ Time Frame: Six months post-randomization. ]
  • Implementation Outcome: Intervention Fidelity [ Time Frame: Six months post-randomization. ]
  • Effectiveness Outcome: T2D Risk [ Time Frame: Baseline and six months post-randomization. ]
  • Effectiveness Outcome: Overall Quality of Life [ Time Frame: Baseline and six months post-randomization. ]
  • Effectiveness Outcome: Health-Related Quality of Life [ Time Frame: Baseline and six months post-randomization. ]
  • Effectiveness Outcome: Health-attached QoL Meaning and Perceptions [ Time Frame: Baseline and six months post-randomization. ]
  • Effectiveness Outcome: Happiness [ Time Frame: Baseline and six months post-randomization. ]
  • Effectiveness Outcome: Happiness Meaning and Perceptions [ Time Frame: Baseline and six months post-randomization. ]

Central Contacts and Locations

Central contacts

Cilia Mejia-Lancheros (Study Research Lead), RN, MPH, Msc. GHP, PhD

437 216 6209Cilia.Mejia-Lancheros@thp.ca

Locations

Wellfort Community Health Services

Recruiting

Brampton, Ontario, Canada, L6T 3J1

Contacts

Principal Investigator:

Ian Zenlea, MD, MPH

Punjabi Community Health Services (PCHS)

Recruiting

Brampton, Ontario, Canada, L6T 3T6

Contacts

Hamna Khan, MPP

hamna.khan@thp.ca

Principal Investigator:

Ian Zenlea, MD, MPH

More Information

Sponsor

Trillium Health Partners

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Diabetes Risk
  • Diabetes
  • Coaching
  • Intervention
  • Implementation
  • Effectiveness
  • Family
  • Diet Habits
  • Physical Activity
  • Mental Well-being
  • Health Behaviors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Trillium Health Partners on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.