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.

Read Full Scientific Objectives & Methods

Background: Communities from South Asian (SA) and Black African and Caribbean (BAC) backgrounds in the Peel region of Ontario, Canada, experience disproportionately high rates of type 2 diabetes (T2D). The high prevalence of T2D in these communities is driven by a complex set of interrelated factors, including biological predisposition, environmental, and social/behavioural influences, all of which are shaped by social determinants at the societal, system, area, and individual levels. Based on existing collaborative research conducted in these populations in Peel, as well as input from diverse community partners and Peel organizations serving SA and BAC communities, there is a clear need for more family-focused programming to prevent T2D in these communities, particularly community-led and culturally sensitive approaches. Objective: To assess the intervention's preliminary implementation and effectiveness. Findings will inform future adaptation of the health and wellness coaching T2D prevention model and support scale-up in larger implementation and effectiveness studies. Methods: In partnership with local Peel-based community organizations, the research team will recruit 70 SA family dyads and 70 BAC family dyads to participate in a Hybrid Type 2 Effectiveness-Implementation Pilot Randomized Controlled Trial (RCT) with a 12-month person-level follow-up post-randomization and a mixed-methods approach. Of the 70 participating dyads in each community group, 70 will be randomly allocated (1:1) to the intervention group and 70 to the control group. The overall study duration will be 24 months, spanning from participant recruitment through to completion of primary implementation and effectiveness outcome reporting. Family dyad participants in the intervention group will receive tailored, human-delivered health and wellness coaching for the T2D prevention program over 12 months, delivered in two main stages. Stage 1 (0-6 months post randomization): Dyad participants will receive biweekly diabetes-focused coaching sessions, supplemented by a monthly group-based coaching session. The intervention group will also receive a co-designed educational booklet on diabetes prevention and a weekly short motivational coaching reminder (via email or text, depending on participant preferences). Stage 2 (6-12 months): After completing Stage 1, dyad participants will receive at least one coaching session and will continue to receive monthly brief motivational reminders. At the end of the 12-month follow-up, participants will complete the study through a coaching closeout assessment session conducted by the team coaches. The control dyad group will receive the same co-designed diabetes prevention booklet as the intervention group but will not receive additional coaching support during the 12-month follow-up period. At the end of the follow-up period, control participants will conclude their participation in the study by completing a survey-based assessment of T2D goal attainment, administered by research team staff. Primary co-implementation outcomes will include acceptability, appropriateness, reach, adoption (uptake), availability, and fidelity. These outcomes will be assessed through semi-structured qualitative interviews conducted by research staff, supplemented with brief survey-based measures. Reach will be assessed from baseline through the recruitment period, while all other outcomes will be measured at 6 and 12 months post-randomization. Co-effectiveness primary outcomes will include hemoglobin A1c (HbA1c) and quality of life. Secondary outcomes will include goal-achievement progress, diabetes knowledge, biomarkers (lipid panel), blood pressure, body weight and adiposity, dietary behaviours, cooking practices, diet-related self-efficacy, healthy food intake patterns, and physical activity, sleep duration, quality, satisfaction, and environmental influencing factors; mental well-being state; perceived stress; resilience; and family functioning. Tertiary outcomes will include the intervention's impact on family well-being. Objective measures (biomarkers, blood pressure, body weight, and adiposity) will be collected in person by research staff at enrolment (T1), 6 months (T2), and 12 months (T2). All remaining outcomes will be assessed using self-administered surveys with validated scales, structured questions, and qualitative open questions at baseline (T1), 6 months (T2), and 12 months (T3) from the randomization date. The investigators will use a mixed-methods, cross-sectional and longitudinal convergence-analytical approach to integrate quantitative and qualitative data and, when possible, identify areas of convergence, complementarity, or divergence across implementation and effectiveness outcomes. Primary effectiveness outcomes will be analyzed using an intention-to-treat approach, accounting for repeated measures, interdependence within dyads when applicable, and variation in person-time follow-up. The investigators will estimate and report observed effect sizes, along with their corresponding 95% confidence intervals, for all outcomes using mixed-effects models or Generalized Estimating Equations, as appropriate. Secondary analyses will further explore potential complex, interrelated associations between implementation and effectiveness outcomes, as well as the influence of socio-demographic and other factors on these relationships. For qualitative data, the investigators will apply a Qualitative Longitudinal Research approach to analyze repeated qualitative data collected for both implementation and effectiveness components. Finally, the investigators will conduct a mixed-methods analysis, integrating findings from both qualitative and quantitative strands to assess their alignment, divergence, or complementarity. Findings: Both implementation and effectiveness findings will be reported, contributing important evidence on the delivery and impact of the piloted health and wellness coaching intervention for T2D prevention among SA and BAC family dyads. These findings will help assess refinements to the intervention model and implementation approach and provide preliminary estimates of potential impact across primary, secondary, and tertiary indicators. Investigators will also assess whether the proposed theory of change is supported, specifically whether the intervention contributes to reducing T2D risk and improving quality of life by supporting participant- and family-tailored diabetes prevention goals, and whether it influences intermediate drivers of T2D risk. Conclusion: The findings and methodological approach of the pilot-tested proposed intervention will guide the design of larger-scale implementation and effectiveness studies across the same or different communities and settings to further assess its real impact on reducing T2D risk and the main driving factors associated with it.

BEHAVIORALFamily 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.

BEHAVIORALEducational 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.

Treatment Arms Description

Primary Outcome Measures

Implementation Outcome: Intervention Acceptability — Time Frame: Six months post-randomization and twelve months post-randomization
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 — Time Frame: Six months post-randomization and twelve months post-randomization
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 — Time Frame: Baseline
Definition: The proportion of and representation of the targeted SA and BAC family dyads that participated 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 14-18 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) — Time Frame: Six months post-randomization and twelve months post-randomization
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.
Implementation Outcome: Intervention Availability — Time Frame: Six months post-randomization and twelve months post-randomization
Definition: The extent to which the intervention is supplied and accessible at any given time. Level and unit of analysis: At the provider (coaches) and study participant level. Measure: Level of availability and perceived accessibility. Data collection and instruments: Data will be obtained from quantitative measures derived from study and intervention delivery logs at the coach and site levels, as well as from individual semi-structured interviews (accessibility perceptions and driving factors) with the study's intervention coaches and participants in the intervention group. Examples of specific measures: 1) Percentage of participants able to access a session within the first month of enrolment (randomization); 2) Attendance rates at scheduled sessions; 3) Percentage of participants reporting satisfaction with program availability; and 4) Number of last-minute cancellations by participants (participant-related diverse reasons).
Implementation Outcome: Intervention Fidelity — Time Frame: Six months post-randomization, and twelve months post-randomization
Definition: The degree to which the intervention was consistently implemented as planned. Level and unit of analysis: At the provider (coaches) and study participant level. Measure: Level of fidelity and driving factors. Data collection and instruments: Quantitative/qualitative measures using intervention delivery logging, fidelity checklist, audio-recorded coaches' sessions, and semi-structured interviews. Measures include 1) A self-fidelity score ( based on a self-reported fidelity checklist collected after each coaching session). 2) External-fidelity monitoring. A trained independent assessor will also evaluate intervention delivery logs and a sample (10-20%) audio-recorded coaching sessions to determine a fidelity score on a 0-100 scale for the following dimensions: a) Adherence /Content delivered, b) Dose/Dose delivered and received; and c) Coaching Delivery Quality (competence delivery).

View Secondary Outcome Measures (25)

Effectiveness Outcome: Diabetes Prevention Knowledge — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
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 youth participants. Analytical level: At the dimension-specific score.
Effectiveness Outcome: Intervention Contribution to Diabetes Knowledge — Time Frame: Six months post-randomization, and twelve months post-randomization
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 youth participants. Analytical level: Salient drivers of diabetes prevention knowledge will be identified from the qualitative data.
Effectiveness Outcome: Lipids — Time Frame: Baseline, six months post-randomization, twelve months post-randomization
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 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 — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
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 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.
Effectiveness Outcome: Body Weight — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: Body weight (kg) will be measured by the research team rather than self-reported, using a validated weighing scale. Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: As a continuous outcome (kg).
Effectiveness Outcome: Waist Circumference — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: It will be measured with a waist circumference tape (cm) by a trained team member following WHO STEPS procedures. Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: The obtained WC values will be analyzed as a continuous variable for all participants and as a categorical variable for participants aged 18 or older (Low-risk WC and High-risk WC).
Effectiveness Outcome: Body Mass Index — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: It will be derived from body weight (kg) and height (m) measurements to obtain Body Mass Index (BMI) in kg/m². Height will be measured using a mobile height-measurement stadiometer by our trained research team, following WHO STEPS procedures. The weight measure has been explained in the weight-level outcome. Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: BMI will anayzed as continuous vairbale , as well as categoric weight variable as follows: Normal (BMI ≥18.5- 24.9 kg/m²), Overweight (BMI ≥ 25- 29.9 kg/m²), Obese (BMI ≥ 30 kg/m²)for participants aged 18 or older. For participants under 18 years, BMI will be categorized into weight status groups (possibly underweight, healthy weight, possibly overweight, possibly obese) based on children's age and sex WHO growth charts (ages 2 to 19) for Canada.
Effectiveness Outcome: Diet Cooking Practices Behaviours — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: A five-point Likert scale, ranging from always=5 to never =1, of their healthy cooking practice behaviours in the last week, using the following questionnaire: 1. Does not add salt to food at the table 2. Replaces salt with herbs and spices 3. Replaces shortening/lard with vegetable oil 4. Modifies recipes to lower sugar or fat 5. Modifies recipes to increase fibre 6. Uses healthy cooking methods (e.g., baking, grilling, steaming, or air frying) instead of deep frying 7. Adds extra vegetables to casseroles and soups 8. Plans meals using MyPlate method (or other meal planning methods) to include balanced and nutritious 9. Checks nutrition facts label on food packages 10. Prepares meals and snacks at home Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: Item-level scores range from 1-5. Responses of "sometimes" to "always" will be recoded as 1(yes) and "rarely" or "never" as 0(no), then summed in a total score (0-10).
Effectiveness Outcome: Healthy Food Preparation Driven Factors — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: It will be assessed using the following qualitative questions: 1\) What kinds of challenges or barriers, if any, have you \[your family caregiver for youth, if they do not cook\] experienced when trying to cook healthy meals at home? 2) Has the program helped you \[ your family caregiver for youth, if they do not cook\], find ways to overcome some of these barriers? 3) How have your family's preferences or cultural traditions influenced the way you \[your family caregiver for youth is they do not cook\] cook or the changes you've made since the program? 4) Have you found ways to make traditional dishes healthier? Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: Salient food preparation driven factors.
Effectiveness Outcome: Self-efficacy in Cooking — Time Frame: Baseline, six months post-randomization, and twelve months post-randomization
Measure: It will be measured using the following question: How confident do you feel in your ability \[or your family caregiver's ability for youth if they do not cook\] to prepare healthy meals regularly? The response options will be rated on a 5-point Likert scale: Not at all confident (1); Slightly confident (2); Moderately confident (3); Very confident (4); Extremely confident (5). Assessment participant unit: Adult family caregiver participants and youth participants. As self-efficacy cooking score, range 1 to 5.

This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 2 Facilities & Contact Sites

Wellfort Community Health Services

Brampton, Ontario, Canada

Status: Open

Punjabi Community Health Services (PCHS)

Brampton, Ontario, Canada

Status: Open

Lead Sponsoring Institution

Trillium Health Partners

Collaborators: Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Primary Research Contact

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

Tel: 437 216 6209

Email: Cilia.Mejia-Lancheros@thp.ca

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Subject: Inquiry about clinical trial enrollment: NCT07675551 - Peel Family Diabetes Prevention Program

Dear Study Coordinator / Research Team, I hope this message finds you well. My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Peel Family Diabetes Prevention Program" (NCT ID: NCT07675551). I am [Age] years old and have been diagnosed with Diabete Type 2. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate. Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening? Thank you for your time and research efforts. Warm regards, [Your Name]

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