About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 children aged 25 years or under in the same household. AND
Have no medical diagnosis (self-reported) of diabetes.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Family Dyad Health and Wellness Coaching Session
BehavioralBiweekly 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
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
Implementation Outcome: Intervention Acceptability
Definition: The perception among our intervention participants (SA and BAC) and coaches that the delivery of the intervention curriculum is agreeable, palatable, or satisfactory. Level and unit of analysis: At the provider (coaches) and study participant level. Measure: Level of rating and perceived intervention's approval, appeal, likeness, and welcoming. Data will be collected from intervention participants and study coaches using semi-structured interviews and surveys. Interviews will use open-ended questions to explore perceived acceptability, including appropriateness, appeal, likeability, and a sense of welcome. Acceptability will also be measured using the 4-item Acceptability of Intervention Measure (AIM), rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater acceptability.
Implementation Outcome: Intervention Appropriateness
Definition: The perceived fit, relevance, or compatibility among our intervention participants and coaches (frontline intervention providers) of the intervention content and format in addressing their needs for T2D prevention associated with T2D risk factors. Level and unit of analysis: At the provider (coaches) and study participants' level. Measure: Level of rating and perceived fit, relevance, compatibility, suitability, and usefulness. Data collection and instruments: Data collected through individual semi-structured interviews and surveys. Interviews will explore perceived fit, relevance, compatibility, suitability, usefulness and practicality of the intervention content and format. The survey includes a 4-item Acceptability scale with a 1-5 score (1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree), as well as qualitative questions.
Implementation Outcome: Intervention Reach
Definition: The proportion of and representation of the targeted SA and BAC participants in the intervention. Level and unit of analysis: At the study participant level. Measure: Reach rates and related factors. Data collection and instruments: Measured as the reach rate of the targeted population (percentage of eligible families with children aged 25 years or under in Peel of BAC and SA communities that were enrolled in the study), and the percentage of representativeness of the enrolled participants in relation to the SA and BAC population as related to socio-demographic and T2D risk. Qualitative questions exploring drivers of participation will be assessed at screening and enrolment using the expression of interest form, eligibility assessment form, and/or consent form. For example, participants will be asked: "What motivated you to participate in this study?"
Implementation Outcome: Intervention Adoption (Uptake)
Definition: The decision or effort to begin using/implementing the plans/advice from the coaches. Level and unit of analysis: At the study participant level. Measure: Level of rating and perceived intervention's approval, appeal, likeness, and welcoming. Data collection and instruments: Quantitative measures will include enrolment rates; initial uptake (defined as the proportion of intervention participants and family dyads attending at least two sessions within the first month of enrolment); uptake at the end of the active intervention stage; and uptake at the end of the sustainability stage. Qualitative data will be collected through interviews using open-ended questions to explore reasons for enrolment, initiation of the health and wellness T2D coaching intervention, and factors influencing participation, adherence, and completion.
Secondary outcomes
Effectiveness Outcome: Diabetes Prevention Knowledge
Measure: 1) Diabetes Prevention Knowledge level for the "Causes" and "Duration" of diabetes using the Diabetes Knowledge Questionnaire (DKQ). The DKQ dimension questions are rated using a three-response format: true (T), false (F), and don't know (DK). A score with a range of 0-100 will be calculated using the following formula: Number of correct responses /maximum possible score in that dimension, multiplied by 100. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: At the dimension-specific score.
Effectiveness Outcome: Intervention Contribution to Diabetes Knowledge
Measure: It will be measured using qualitative open-ended questions such as follows: 1. Since participating in this program, what new information have you learned about T2D that you didn't know before? 2. Has your awareness of how to manage or prevent diabetes improved? If yes, in what ways? 2\) Which aspects of diabetes prevention (e.g., diet, exercise, stress management, seek help) do you feel more confident about now compared to before the intervention? 3) Have your attitudes or intentions toward diabetes prevention changed due to your participation in this program? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient drivers of diabetes prevention knowledge will be identified from the qualitative data.
Effectiveness Outcome: Lipids
Measure: The lipid panel will include total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and non-high-density lipoprotein-cholesterol (non-HDL-C). It will be obtained using the participant's capillary blood (finger-prick) sample with a validated Point-of-Care (POC) device. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: 1) Quantitative (continuous) outcome measure (mm/L) for each of the lipid panel components (TC, HDL, LDL, TG, non-HDL). 2) As a clinically significant range (category) according to the 2021 Canadian Cardiovascular Society Guidelines using the Framingham Risk Score (FRS) stratification and paediatrics guidelines.
Effectiveness Outcome: Blood Pressure
Measure: Three blood pressure (SBP) and diastolic blood pressure (DBP) measurements will be taken using a digital blood pressure device. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: As continuous measures, the average systolic blood pressure (SBP, mmHg) and diastolic blood pressure (DBP, mmHg) were calculated from three readings. Then, the optimal blood pressure level will be analyzed by categorizing SBP and DBP values into clinically significant ranges according to the Hypertension Canada Guidelines (2025): Optimal blood pressure is defined as the mean of three readings: \<130 (SBP)mmHg/80 (DBP) mmHg.
Other outcomes
Other Effectiveness Outcome: Extended Family Well-Being Impact
Measure: It will be assessed with a yes/no closed-ended question to determine whether a positive effect is present at the broader family level. If yes: a) Impact will be assessed using multiple-choice options and a self-reported rating on a 7-point Likert scale (1 = very low positive impact; 7 = maximum positive impact); b) Impact areas will be measured using a closed-ended question covering nine domains (e.g., healthier eating habits, increased physical activity, improved knowledge of diabetes prevention, reduced stress or improved emotional well-being, better communication about health and lifestyle, increased family support for healthy behaviours); and c) Respondents will indicate which family members were impacted. If no family members were impacted, an open-ended question will explore the reasons why. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Categorical, ordinal impact levels, and salient insights.
Sponsors and contacts
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Trillium Health Partners
Lead sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborator