An interventional study of Family Dyad Health and Wellness Coaching Session and Educational Material in Diabete Type 2, sponsored by Trillium Health Partners. Recruiting at 2 sites in Canada. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Trillium Health Partners · Not applicable, Interventional, and Prevention
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.
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 (plus optional youth) and 70 BAC family caregivers (plus optional youth) to participate in a Hybrid Type 2 Effectiveness-Implementation Pilot Randomized Controlled Trial (RCT) with a six-month person-level follow-up post-randomization and a mixed-methods approach. Of the 70 participating caregivers (plus optional youth) 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 22 months, spanning from participant recruitment through to completion of primary implementation and effectiveness outcome reporting.
Family caregiver participants (family caregiver plus optional youth) in the intervention group will receive tailored, human-delivered health and wellness coaching for the T2D prevention program over six months, where they 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). At the end of the six-month coaching follow-up, participants will complete the study through a coaching closeout assessment session conducted by the team coaches.
The participant in the control group (family caregiver plus optional youth) will receive the same co-designed diabetes prevention booklet as the intervention group but will not receive additional coaching support during the six-month follow-up period. At the end of the person 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 month post-randomization.
Co-effectiveness primary outcomes will include hemoglobin A1c (HbA1c) and quality of life measures. 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) and 6 months (T2). All remaining outcomes will be assessed using self-administered surveys with validated scales, structured questions, and qualitative open questions at baseline (T1) and 6 months (T2) from the randomization date.
The investigators will use a mixed-methods, cross-sectional and longitudinal (when applicable) 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 and interdependence within family dyads (when family caregiver and optional youth) 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 descriptive statistics and mixed-effects models or Generalized Estimating Equations, when 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 one point or Qualitative Longitudinal Research (when two points data are available) approaches 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 feasibility, delivery and impact of the piloted health and wellness coaching intervention for T2D prevention among SA and BAC family caregiver plus optional youth (when applicable). These findings will help assess future study feasibility, refinements to the intervention model and implementation approach, as well as provide preliminary estimates of potential impact across primary, secondary, and tertiary health-related 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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Trillium Health Partners is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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:
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 test using a finger prick at the pre-enrollment assessment visit. AND
Exclusion Criteria for family dyad:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Family Dyad Health and Wellness Coaching Session · Behavioral: Educational Material
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.
Behavioral: Educational Material
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.
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.
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.
Time frame: Six months post-randomization.
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.
Time frame: Six months post-randomization.
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?"
Time frame: Baseline.
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.
Time frame: Six months post-randomization.
Implementation Outcome: Intervention Availability
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).
Time frame: Six months post-randomization.
Implementation Outcome: Intervention Fidelity
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).
Time frame: Six months post-randomization.
Effectiveness Outcome: T2D Risk
Measure: 1)Capillary Blood Hemoglobin A1C (%), measured using Point-of-care (POC) A1C testing. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: 1) As a quantitative (continuous) outcome measure (%); and 2) as a clinically significant range (Non-prediabetic (non-prediabetic diabetic): A1C \<6.0%. Prediabetes: A1C between 6.0% and \<6.5%. Diabetes: A1C \> 6.5%).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Overall Quality of Life
Measure: 1) Overall quality of life (QoL) will be assessed using the EQ-5D-5L tool. The EQ-5D-5L measures five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale (1 = no problems to 5 = extreme problems). Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: 1) The EQ-5D-5L overall health index score. 2) The EQ-5D-5L dimension-specific scores.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Health-Related Quality of Life
Measure: It will be measured using the EQ VAS, whose values range from 0 to 100, reflecting overall health (0 = worst imaginable health; 100 = best imaginable health). Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Overall health rated score of the EQ VAS.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Health-attached QoL Meaning and Perceptions
Measure: The perceived level of health-related quality of life (QoL) will be assessed using qualitative questions, such as: 1. When you think about health, what does it personally mean to you, and how does that meaning relate to the number you selected on the health scale (EQ-VAS)? 2. Can you explain why you chose that number on the health scale (EQ-VAS) today? 3. What aspects of your health, daily life, or overall well-being influenced your rating? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient findings will be derived from qualitative data.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Happiness
Measure: 1) Well-being will be assessed using the VAS-Happiness Scale, with a value range of 0 to 100 (0 = completely unhappy, 100 = completely happy). 2) A qualitative happiness assessment using open-ended questions will complement the VAS-Happiness Scale, exploring participants' perceptions of the meaning and interpretation of VAS-Happiness Scale score selection. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: 1) Overall VAS-Happiness score; and 2) Salient qualitative happiness themes (definition and driving scoring factors).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Happiness Meaning and Perceptions
Measure: It will be assessed using qualitative questions to help participants contextualize their happiness rating level and express their unique perceptions. Qualitative questions that will be used are as follows: 1) When you think about happiness, what does it personally mean to you, and how does that meaning relate to the number you selected on the scale? 2) Can you describe what influenced your rating on the happiness scale today? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient happiness definition and driving scoring factors.
Time frame: Baseline and six months post-randomization.
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.
Time frame: Baseline and six months post-randomization.
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.
Time frame: Six months post-randomization.
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.
Time frame: Baseline and six months post-randomization.
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.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Body Weight
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 optional youth participants. Analytical level: As a continuous outcome (kg).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Waist Circumference
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 optional 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).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Body Mass Index
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 optional youth participants. Analytical level: BMI will analyzed as continuous variable , 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.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Diet Cooking Practices Behaviours
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 optional youth participants. Analytical level: Item-level scores (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).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Healthy Food Preparation Driven Factors
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 optional youth participants. Analytical level: Salient food preparation driven factors.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Self-efficacy in Cooking
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 optional youth participants. As self-efficacy cooking score, range 1 to 5.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Factors Influencing Cooking Self-efficacy
Measure: It will be measured using the following qualitative questions: 1) Can you describe what makes you feel confident \[or your family caregiver's ability for youth if they do not cook\] or not confident in preparing healthy meals regularly? 2) How does your confidence \[or your family caregiver's ability for youth, if they do not cook\] in meal preparation affect your family's eating habits or routines? 3) Have you noticed any changes over time in your confidence \[or your family caregiver's ability for youth, if they do not cook\] and what contributed to those changes? 4) How have your family members responded to these changes? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors for self-efficacy in cooking.
Time frame: Baseline and six months post-randomization.
Effectiveness outcome: Healthy Food Intake
Measure: Healthy food intake patterns. It will be assessed using the MyPlate method over a week (more than 3 days), in which participants self-report typical eating patterns following MyPlate recommendations (half the plate filled with non-starchy vegetables, a quarter of the plate filled with carbohydrate foods, and a quarter of the plate filled with protein foods), other foods, and beverage intake. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: As categorial intake patterns (%) and count-based intake frequency (0,1,2,3…) of non-starchy vegetables, carbohydrate foods, protein foods, beverages, and other foods. Beverage intake type and frequency (number of glasses).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Driving Factors of Healthy Foods Intake Patterns
Measure: It will be measured using the following questions: 1\) What are the main reasons you were not able \[or able\] to follow the MyPlate food intake recommendations (for example, filling half your plate with vegetables, one-quarter with carbohydrates, and one-quarter with protein)? Lack of time to prepare balanced meals. * Limited access or affordability of healthy foods. * Cultural or taste preferences. * Lack of knowledge or cooking skills. * Family or household food preferences. \_\_Other (please specify)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors of healthy food intake.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Physical Activity
Measure: Physical activity engagement level will be evaluated using the Physical Activity Vital Sign (PAVS) 2-item tool. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Weekly physical activity engagement level as a continuous measure: Total minutes of physical activity /week (minutes/week). Additionally, physical activity engagement will be categorized as a clinically significant variable based on the World Health Organization (2020) guidelines on physical activity and sedentary behaviour for adults (≥18 years) as low (\< 150 of average minutes/week) or high (≥150 of average minutes /week), and for children (\<18 years) as low (\< 60 of average minutes minutes/day, or \<420 minutes/week) or high (≥60 of average minutes minutes/day, or ≥420 minutes/ week).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Driving Factors of Physical Activity Engagement
Measures: It will be assessed using the following qualitative open-ended questions: 1. What makes it difficult \[easy\] for you to engage in regular physical activity? 2. Can you describe any personal, economic, social, or environmental factors that limit \[ encourage\] your activity? 3) Are there specific programs, spaces, or tools that make it easier for you to exercise? 4) In what ways has engagement in the prevention program impacted your engagement in physical activity on a regular basis? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient barriers to physical activity and categorical type of influencing factors, as well as perceived impact of the intervention in enhancing physical activity.
Time frame: Baseline and six months post-randomization for questions 1 to 3. Six months post-randomization for question 4.
Effectiveness Outcome: Sleep Duration Behaviour
Measure: Sleep duration will be measured using the adapted 24-hour sleep duration question used in the National Longitudinal Study of Adolescent to Adult Health Parent Study. How many hours of sleep do you typically get each day? \[HH:MM\]. The question has been adapted to assess sleep duration patterns between the typical work or school day and the non-work or non-school day. Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Total minutes of sleep duration (minutes/week), as well as sleep duration on workday/school days (minutes/week) and on weekend days (minutes/week).
Time frame: Baseline and six months post-randomization.
Effectiveness outcome: Sleep Quality, Satisfaction, Environmental Influential Factors
Measures: It will be assessed using qualitative questions as follows. Workdays/schooldays Sleeping: 1)How would you describe the overall quality of your sleep on workdays or school days? 2) How satisfied are you with the amount and quality of sleep you typically get during workdays or school days? 3) Are there any environmental factors (e.g., noise, light, temperature, or household distractions) that affect your ability to get sufficient sleep during workdays or school days? Non-workday or Non-school Days: 1) How would you describe the overall quality of your sleep on weekend days? 2) How satisfied are you with the amount and quality of sleep you typically get during the weekend days? 3) Are there any environmental factors (such as noise, light, temperature, household environment) that affect your ability to get sufficient sleep during the weekend? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient factors.
Time frame: Baseline and six months post-randomization.
Effectiveness outcome: Mental/Emotional Well-Being
Measure: It will be measured using the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS), in which each item is rated on a 5-point Likert scale (1 = One of the time, 2 = Rarely, 3 = Some of the time, 4 = Often, 5 = All of the time). Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: As the total WEMWBS score, and as a categorical: Meaningful improvement (defined as an increase of ≥3 points from baseline) and Non-meaningful improvement (an increase of less than \<3 points from baseline).
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Driving Factors of Mental Well-being
Measure: It will be assessed using qualitative open-ended questions, as follows: 1. What kinds of experiences, relationships, social/cultural influence or daily activities have the greatest positive impact on your mental well-being? 2. Can you describe any challenges or situations that make it harder for you to feel mentally/emotionally well or maintain a positive outlook? 3. What supports, resources, or community connections help you the most in maintaining or improving your mental well-being? 4. Have there been any changes in your mental well-being recently? Do you think participating in this community and research-informed study has contributed positively \[or negatively\] to your mental well-being changes? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors of mental well-being.
Time frame: Baseline and six months post-randomization for questions 1 to 3. Six months post-randomization for question 4.
Effectiveness Outcome: Perceived Stress
Measure: It will be measured using the Perceived Stress Scale (PSS-10), a 10-item questionnaire assessing feelings and thoughts over the past month on a 5-point Likert scale (0 = never to 4 = very often). Assessment participant unit: Adult family caregiver participants and youth participants. Analytical level: The total score of the PSS-10, and as perceived stress categories (constructs) scores: a) Perceived helplessness total score, and b) Perceived self-efficacy total score.
Time frame: Baseline, six months post-randomization, and twelve months post-randomization
Effectiveness Outcome: Driving Factors of Stress
Measure: It will be assessed using qualitative, open-ended questions, such as follows: 1. Can you describe the main things in your life that currently cause you stress or make you feel overwhelmed? 2. Who or what supports you the most when you are feeling stressed (e.g., people, activities, places, beliefs)? 3. How do your surroundings, such as school, work, family, or community, affect your stress levels? 4. Have you noticed any changes in what causes you stress or how you handle it over time? 5. Do you think the intervention you are participating in contributed to these changes? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors of perceived stress.
Time frame: Baseline and six months post-randomization for questions 1 to 3. Six months post-randomization for questions 4 and 5.
Effectiveness outcome: Resilience
Measure: Measured using 1) the Connor-Davidson Resilience Scale (CD-RISC-2), 2-item version, rated on a 5-point Likert scale (0 = Not true at all, 1 = Rarely true, 2 = Sometimes true, 3 = Often true, 4 = True nearly all the time). Assessment participant unit: Adult family caregiver participant and optional youth participant. Analytical level: Total score of the CD-RISC-2.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Driving Factors of Resilience
Measure: Driving factors of resilience related to self-perception of resilience, learning from challenges, and resilience support/connections will be assessed using the following qualitative open-ended questions: 1. How would you describe your ability to bounce back from setbacks, and what do you think makes you resilient? 2. Can you share an experience where facing a difficulty helped you grow or see things differently? 3. Who or what do you turn to for support during tough times, and how does that help you? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors of resilience.
Time frame: Baseline and six months post-randomization.
Effectiveness Outcome: Family Functioning
Measure: It will be assessed using the Brief Assessment of Family Functioning Scale (BAFFS), which comprises three items rated on a 4-point Likert scale (1 = Strongly Agree, 2 = Agree, 3 = Disagree, and 4 = Strongly Disagree). Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: The total score of the BAFFS. As family functioning's categories (construct) based on total BAFFS score: a) Satisfaction with family functioning: BAFFS ≤ 6. b) Family distress: BAFFS \> 6.
Time frame: Baseline and six month post-randomization.
Effectiveness Outcome: Driving Factors of Family Functioning
Measure: Driving factors of family functioning related to support and cohesion, roles and problem-solving, and the program contributing to family functioning will be assessed with qualitative questions: 1. What kinds of support do family members provide to each other? 2. How are responsibilities and problem-solving roles shared within your family? 3. How does it contribute to family functioning? 4. How has your family's functioning changed, if at all, because of participating in this program? 5. In what ways do you think your family relationships, communication, or other factors \[such as social support, stress, or cultural values\] have influenced these changes or your experience with the program? Assessment participant unit: Adult family caregiver participants and optional youth participants. Analytical level: Salient driving factors of family functioning.
Time frame: Baseline and six months post-randomization for questions 1 to 3. Six months post-randomization for questions 4 and 5.
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.
Time frame: Six months post-randomization.
Plan to share: Yes — External academic researchers and community partners may request access to de-identified study data to conduct secondary analyses, including analyses related to research, implementation, effectiveness, or data synthesis (e.g., meta-analyses). Participant identifiers data will not be shared. Data that can be shared include implementation data, effectiveness data, and socio-demographic data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Study data for external use may be available from approximately April 2030 to March 2035. The study protocol will be open access and published in an international academic journal between October and November 2026. It will contain the main study processes, including the data analysis plan. A study community report will be available between approximately June and October 2028. Primary and secondary results analyses will be made publicly available between approximately December 2028 and March 2030.
Access criteria: The core IBH/THP research team, including co-investigators and relevant community partners, will retain priority access and use of the collected de-identified study data. This priority applies to analyses addressing the primary and secondary implementation and effectiveness outcomes as specified in the approved study protocol. All requests for secondary use of study data must be submitted via formal written email to the IBH/THP Principal Investigator (PI), Dr. Ian Zelea, at Ian.Zenlea@thp.ca. If approval is granted by the research team, a Data Access Agreement (DAA) will be developed in accordance with ethical requirements, institutional research policies and data access practices of the host institution(s) (IBH/THP). The DAA will specify the conditions of data use, data security, confidentiality, and reporting obligations. The DAA will be signed by all relevant parties, including the PI, the data requester, and, where required, an IBH/THP institutional representative.
Started May 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 10 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Sep 2027 → Mar 2027 and completion Mar 2028 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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