Peel Family Diabetes Prevention Program

Официальное название

Peel Family Diabetes Prevention Program (Peel FDPP): Family-Centred Health and Wellness Coaching Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Family Dyad Health and Wellness Coaching Session
  Biweekly health and wellness coaching sessions (in-person or virtual) for type 2 diabetes, provided by trained community-based coaches. The maximum session length will be 30 minutes, with no mandatory minimum. Coaches will also share a short weekly motivational message, delivered to participants' phones or emails, depending on preferences. The intervention group participants may join an optional monthly group-based health and wellness coaching session with other program participants. Group sessi
• Поведенческое Educational Material
  A printed or digital educational booklet on type 2 diabetes (T2D) prevention. The booklet contains information related to the causes and signs of T2D, diet and physical activity engagement activities, mental well-being enhancement and stress management, strategies to set up positive lifestyles and behavioural change, along with a list of local health and social support services that may be used to further promote overall well-being and support T2D risk reduction.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Effectiveness Outcome: Diabetes Prevention Knowledge [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Intervention Contribution to Diabetes Knowledge [Срок оценки: Six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Lipids [Срок оценки: Baseline, six months post-randomization, twelve months post-randomization]
• Effectiveness Outcome: Blood Pressure [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Body Weight [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Waist Circumference [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Body Mass Index [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Diet Cooking Practices Behaviours [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Healthy Food Preparation Driven Factors [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Self-efficacy in Cooking [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness Outcome: Factors Influencing Cooking Self-efficacy [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]
• Effectiveness outcome: Healthy Food Intake [Срок оценки: Baseline, six months post-randomization, and twelve months post-randomization]

Критерии участия

Критерии включения

Dyad participants will consist of a self-identified primary family caregiver aged 18 years or older and a youth family member aged 14 to 24 years at the time of study entry. The primary family caregiver will serve as the primary (index) research participant for the dyad and should have the following inclusion criteria:

• 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.

Exclusion Criteria for family dyad:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Канада · 2 центра

• Wellfort Community Health Services — Brampton
• Punjabi Community Health Services (PCHS) — Brampton

Публикации

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• Expert Panel on Integrated Pediatric Guideline for Cardiovascular Health and Risk Reduction. Pediatrics. 2012;129:e1111. https://doi.org/10.1542/peds.2012-0210.
• Sousa MR, McIntyre T, Martins T, Silva E. Questionário dos Conhecimentos da Diabetes (QCD): propriedades psicométricas. Revista Portuguesa de Saúde Pública. 2015;33:33-41. https://doi.org/10.1016/j.rpsp.2014.07.002.
• Harris KM, Hotz VJ. National Longitudinal Study of Adolescent to Adult Health (Add Health) Parent Study: Public Use, [United States], 2015-2017. 2020. https://www.icpsr.umich.edu/web/NACDA/studies/37375/versions/V3. Accessed 12 Nov 2025.
• Mansfield AK, Keitner GI, Sheeran T. The Brief Assessment of Family Functioning Scale (BAFFS): a three-item version of the General Functioning Scale of the Family Assessment Device. Psychother Res. 2019 Aug;29(6):824-831. doi: 10.1080/10503307.2017.1422213. Epub 2018 Jan 19. PMID 29351729
• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. PMID 18042300
• Robbins R, Quan SF, Barger LK, Czeisler CA, Fray-Witzer M, Weaver MD, Zhang Y, Redline S, Klerman EB. Self-reported sleep duration and timing: A methodological review of event definitions, context, and timeframe of related questions. Sleep Epidemiol. 2021 Dec;1:100016. doi: 10.1016/j.sleepe.2021.100016. Epub 2021 Nov 25. PMID 35761957
• Coleman KJ, Ngor E, Reynolds K, Quinn VP, Koebnick C, Young DR, Sternfeld B, Sallis RE. Initial validation of an exercise "vital sign" in electronic medical records. Med Sci Sports Exerc. 2012 Nov;44(11):2071-6. doi: 10.1249/MSS.0b013e3182630ec1. PMID 22688832

Идентификаторы

NCT: NCT07675551 · THP-RID#00532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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