Peel Family Diabetes Prevention Program

NCT07675551 | Recruiting

• 1 other identifier: THP-RID#00532
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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.

  Six months post-randomization and twelve 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.

  Six months post-randomization and twelve months post-randomization

• Implementation Outcome: Intervention Reach

  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?"

  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.

  Six months post-randomization and twelve 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).

  Six months post-randomization and twelve 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).

  Six months post-randomization, and twelve 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 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%).

  Baseline, six months post-randomization and twelve 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 youth participants. Analytical level: 1) The EQ-5D-5L overall health index score. 2) The EQ-5D-5L dimension-specific scores.

  Baseline, six months post-randomization, and twelve 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 youth participants. Analytical level: Overall health rated score of the EQ VAS.

  Baseline, six months post-randomization, and twelve 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 youth participants. Analytical level: Salient findings will be derived from qualitative data.

  Baseline, six months post-randomization, and twelve 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 youth participants. Analytical level: 1) Overall VAS-Happiness score; and 2) Salient qualitative happiness themes (definition and driving scoring factors).

  Baseline, six months post-randomization, twelve 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 youth participants. Analytical level: Salient happiness definition and driving scoring factors.

  Baseline, six months post-randomization, and twelve months post-randomization

Secondary Outcomes (25)

• Effectiveness Outcome: Diabetes Prevention Knowledge

  Baseline, six months post-randomization, and twelve months post-randomization

• Effectiveness Outcome: Intervention Contribution to Diabetes Knowledge

  Six months post-randomization, and twelve months post-randomization

• Effectiveness Outcome: Lipids

  Baseline, six months post-randomization, twelve months post-randomization

• Effectiveness Outcome: Blood Pressure

  Baseline, six months post-randomization, and twelve months post-randomization

• Effectiveness Outcome: Body Weight

  Baseline, six months post-randomization, and twelve months post-randomization

Other Outcomes (1)

• Other Effectiveness Outcome: Extended Family Well-Being Impact

  Six months post-randomization and twelve months post-randomization

Study Arms (2)

Diabetes-Prevention Health and Wellness Coaching

EXPERIMENTAL

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.

Behavioral: Family Dyad Health and Wellness Coaching Session; Behavioral: Educational Material

Diabetes-Prevention Booklet

ACTIVE COMPARATOR

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.

Behavioral: Educational Material

Interventions

Family Dyad Health and Wellness Coaching Session BEHAVIORAL

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.

Diabetes-Prevention Health and Wellness Coaching

Educational Material BEHAVIORAL

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.

Diabetes-Prevention Booklet; Diabetes-Prevention Health and Wellness Coaching

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a youth child aged 14 to 24 years in the household who is willing and consents to participate. AND
• Have no medical diagnosis (self-reported) of diabetes.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trillium Health Partners: lead
• Sun Life Financial Movement Disorders Research and Rehabilitation Centre: collaborator

Study Sites (2)

Wellfort Community Health Services

Brampton, Ontario, L6T 3J1, Canada

RECRUITING

Punjabi Community Health Services (PCHS)

Brampton, Ontario, L6T 3T6, Canada

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Feeding Behavior; Motor Activity; Psychological Well-Being; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior; Personal Satisfaction

Study Officials

• Ian Zenlea, MD, MPH

  Institute for Better Health, Trillium Health Partners, Mississauga.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Hamna Khan, MPP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the real-world setting and pragmatic nature of the intervention, study dyad participants, intervention delivery coaches, and the core study research team will not be masked to the intervention group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators propose a pilot Hybrid Type 2 Effectiveness-Implementation study (HEI) with a Randomized Controlled Trial (RCT) (1:1) design with a mixed-methods data collection and analysis approach.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 30, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

CA (2)