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 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.

Conditions

Diabete Type 2

Study ID

NCT07675551

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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:

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 a youth child aged 14 to 24 years in the household who is willing and consents to participate. 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 greater 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 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:

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

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Diabetes-Prevention Health and Wellness Coaching

Family dyad Participants will take part in a health and wellness coaching program type 2 diabetes (T2D) prevention, delivered in two stages. In Stage 1 (Active Coaching, months 0-6), participants will: 1) Engage in 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. In Stage 2 (Maintenance Coaching, months 6-12), participants will attend a mandatory coaching session (virtual or in person) in month 9. Additional coaching sessions may be scheduled with the coaches as desired by the participants. No group-based coaching sessions or motivational messages will be provided during Stage 2.

active comparator: Diabetes-Prevention Booklet

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

Hamna Khan, MPP

437-231-6951hamna.khan@thp.ca

Locations

Wellfort Community Health Services

Recruiting

Brampton, Ontario, Canada, L6T 3J1

Contacts

Hamna Khan, MPP

437-231-6951hamna.khan@thp.ca

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

Jun 30, 2026

Last verified

Jun, 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 2026-09-10. This information was provided to ClinicalTrials.gov by Trillium Health Partners on 2026-06-30.