Comparing Family Dyad Health and Wellness with Educational Material for diabete type 2
Official title: Peel Family Diabetes Prevention Program
Peel Family Diabetes Prevention Program (Peel FDPP): Family-Centred Health and Wellness Coaching Pilot Randomized Controlled Trial
- 2 groups
- 2 sites in Brampton
- Recruiting
Interventions
- Behavioural therapy
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 sessions will be approximately 2 hours in length.
- Behavioural therapy
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.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Wellfort Community Health Services
Brampton, Ontario
- Recruiting
Punjabi Community Health Services (PCHS)
Brampton, Ontario
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +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
- +Self-identifies as either South Asian or Black, African and Caribbean.
- +Lives in the Peel Region (Mississauga, Brampton or Caledon), Ontario, Canada.
- +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-enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →, implementation, delivery, and evaluation of the intervention.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate voluntarily in the intervention and study.
Exclusion
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate voluntarily in the intervention and study.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Family Dyad Health and Wellness Coaching Session and Educational Material.
Registry label: A: Diabetes-Prevention Health and Wellness Coaching
Group B, the comparison group, receives Educational Material.
Registry label: B: Diabetes-Prevention Booklet
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 14 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 280 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: Six months post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → and twelve months post-randomization.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Implementation Outcome: Intervention Acceptability — measured over Six months post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → and twelve months post-randomization.
Implementation Outcome: Intervention Appropriateness — measured over Six months post-randomization and twelve months post-randomization.
Implementation Outcome: Intervention Reach — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →.
Implementation Outcome: Intervention Adoption (Uptake) — measured over Six months post-randomization and twelve months post-randomization.
The study lists 8 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07675551 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Family Dyad Health and Wellness Coaching SessionBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Educational MaterialBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 14 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 14 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Six months post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → and twelve months post-randomization.
The study as a whole is currently expected to finish around 2028-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 280 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Brampton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.