Peel Family Diabetes Prevention Program (Peel FDPP): Family-Centred Health and Wellness Coaching Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Implementation Outcome: Intervention Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Implementation Outcome: Intervention Acceptability
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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).
Effectiveness Outcome: T2D Risk
时间窗: Baseline, six months post-randomization and twelve months post-randomization
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%).
Effectiveness Outcome: Overall Quality of Life
时间窗: Baseline, six months post-randomization, and twelve months post-randomization
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.
Effectiveness Outcome: Health-Related Quality of Life
时间窗: Baseline, six months post-randomization, and twelve months post-randomization
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.
Effectiveness Outcome: Health-attached QoL Meaning and Perceptions
时间窗: Baseline, six months post-randomization, and twelve months post-randomization
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.
Effectiveness Outcome: Happiness
时间窗: Baseline, six months post-randomization, twelve months post-randomization
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).
Effectiveness Outcome: Happiness Meaning and Perceptions
时间窗: Baseline, six months post-randomization, and twelve months post-randomization
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.
次要结局
- Effectiveness Outcome: Intervention Contribution to Diabetes Knowledge(Six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Diabetes Prevention Knowledge(Baseline, 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)
- Effectiveness Outcome: Waist Circumference(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness outcome: Healthy Food Intake(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Body Mass Index(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Diet Cooking Practices Behaviours(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Healthy Food Preparation Driven Factors(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Self-efficacy in Cooking(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Factors Influencing Cooking Self-efficacy(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Healthy Foods Intake Patterns(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Physical Activity(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Physical Activity Engagement(Baseline, six months post-randomization, and twelve months post-randomization for questions 1 to 3. Six months post-randomization and twelve months post-randomization for question 4.)
- Effectiveness Outcome: Sleep Duration Behaviour(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness outcome: Sleep Quality, Satisfaction, Environmental Influential Factors(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness outcome: Mental/Emotional Well-Being(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Mental Well-being(Baseline, six months post-randomization, and twelve months post-randomization for questions 1 to 3. Six months post-randomization and twelve months post-randomization for question 4.)
- Effectiveness Outcome: Perceived Stress(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Stress(Baseline, six months post-randomization, and twelve months post-randomization for questions 1 to 3. Six months post-randomization and twelve months post-randomization for questions 4 and 5.)
- Effectiveness outcome: Resilience(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Resilience(Baseline, six months post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Family Functioning(Baseline, six month post-randomization, and twelve months post-randomization)
- Effectiveness Outcome: Driving Factors of Family Functioning(Baseline, six months post-randomization, and twelve months post-randomization for questions 1 to 3. Six months post-randomization and twelve months post-randomization for questions 4 and 5.)