140 Participants NeededMy employer runs this trial

Wellness Coaching for Type 2 Diabetes Prevention

(Peel FDPP Trial)

Recruiting at 1 trial location
CM
HK
Overseen ByHamna Khan, MPP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wellness coaching program designed to prevent type 2 diabetes in South Asian and Black African and Caribbean communities in the Peel region of Ontario, Canada. Participants will either receive health and wellness coaching sessions (Family Dyad Health and Wellness Coaching Session) along with educational materials or just the educational materials to determine which approach more effectively reduces diabetes risk. Ideal candidates are primary family caregivers without diabetes, residing in the Peel region, who self-identify as South Asian or Black, African, and Caribbean, and have children under 25 living with them. The study aims to assess the program's feasibility and effectiveness in improving health behaviors and reducing diabetes risk. As an unphased trial, this study allows participants to contribute to innovative research that could significantly impact community health.

What prior data suggests that this wellness coaching intervention is safe for participants?

Past studies have found wellness coaching to be safe and well-received by participants. These programs typically focus on lifestyle changes and personal support, which carry minimal risk. No reports have indicated serious negative effects directly caused by wellness coaching. Participants often share positive experiences, noting improvements in motivation and lifestyle habits.

As this trial is in its early stages, focusing on effectiveness and implementation, it's important to note that similar studies have not raised major safety concerns. The program includes coaching, motivational messages, and educational materials, all considered low-risk. Prospective participants can feel reassured that wellness coaching is generally regarded as a safe approach.12345

Why are researchers excited about this trial?

Researchers are excited about the Wellness Coaching for Type 2 Diabetes Prevention because it offers a fresh, holistic approach compared to traditional methods like medication and diet changes. Unlike standard care, this program involves family dyad health and wellness coaching, which emphasizes a supportive family environment to encourage lifestyle changes. Participants receive personalized coaching sessions, motivational messages, and the option to join group sessions, making it more interactive and engaging. This approach seeks to empower participants with knowledge and support, potentially making prevention efforts more sustainable and effective in the long term.

What evidence suggests that this wellness coaching intervention is effective for preventing type 2 diabetes?

Studies have shown that health and wellness coaching can lower the risk of developing type 2 diabetes. One study found that adults with prediabetes who completed a human-led diabetes prevention program were 58% less likely to develop type 2 diabetes. Coaching emphasizes lifestyle changes, such as healthier eating and increased physical activity, which are crucial for diabetes prevention. Research also indicates that involving family in these efforts can improve blood sugar control in adults. In this trial, participants in the Diabetes-Prevention Health and Wellness Coaching arm will receive coaching sessions and motivational messages, while those in the Diabetes-Prevention Booklet arm will use educational materials independently. These findings suggest that wellness coaching could effectively reduce diabetes risk in specific communities.678910

Who Is on the Research Team?

IZ

Ian Zenlea, MD, MPH

Principal Investigator

Institute for Better Health, Trillium Health Partners, Mississauga.

Are You a Good Fit for This Trial?

This trial is for South Asian or Black African/Caribbean families in Peel, Ontario. Each family must have an adult caregiver (18+) without type 2 diabetes and not on diabetes medication, plus a youth aged 14-24 living together.

Inclusion Criteria

Primary family caregiver lives in the Peel Region (Mississauga, Brampton or Caledon), Ontario, Canada
Primary family caregiver self-identifies as either South Asian or Black, African and Caribbean
Primary family caregiver has no medical diagnosis (self-reported) of prediabetes requiring medical or pharmacological treatment
See 5 more

Exclusion Criteria

I am not able to give my consent to join this study.
Do not meet all inclusion criteria
Medical condition or health professional advice against engaging in any physical activity or following a specific diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biweekly health and wellness coaching sessions, optional group coaching, weekly motivational messages, and an educational T2D prevention booklet over six months

6 months
Biweekly sessions (in-person or virtual), monthly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of T2D risk and quality of life

6 months
Assessment at 6 months post-randomization

Implementation and Effectiveness Evaluation

Mixed-methods approach to assess implementation and effectiveness outcomes, including qualitative and quantitative data collection

Up to 16 months

What Are the Treatments Tested in This Trial?

Interventions

  • Educational Material
  • Family Dyad Health and Wellness Coaching Session

Trial Overview

The study compares two groups: one gets regular health and wellness coaching sessions plus educational materials to help prevent type 2 diabetes; the other receives only educational materials. Families are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes-Prevention Health and Wellness CoachingExperimental Treatment2 Interventions
Group II: Diabetes-Prevention BookletActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Trillium Health Partners

Lead Sponsor

Trials
8
Recruited
3,100+

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Collaborator

Trials
10
Recruited
510+

Citations

a study protocol for a randomized controlled trial

Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial. May 2024 ...

AI-powered diabetes prevention program shows similar ...

adults with prediabetes who complete a human-led DPP, are 58% less likely to develop type 2 diabetes, on (93.4% vs 82.7%) and completion (63.9% ...

Main, mediated, and subgroup effects from the FAMS 2.0 ...

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Intervention strategies for type 2 diabetes prevention in ...

Overall, there were more female than male participants in the included intervention studies, with 16,999 women compared to 11,406 men.

Preventing Type-2 Diabetes Through Education | PDF

The paper summarizes 5 studies. The Diabetes Prevention Program study found that education decreased diabetes incidence by 58% through lifestyle interventions.

Family Link from Google - Family Safety & Parental Control ...

Family Link gives parents the tools they need to create a safer online experience for their kids and empower them to build healthy digital habits together.

7.

familysearch.org

familysearch.org/

Find your family. Free Genealogy Archives

Start discovering your family story. Search billions of ancestor profiles, photographs, and historical documents at once—absolutely FREE.

Family (disambiguation)

A family is a domestic or social group. Family or The Family may also refer to: a group in the periodic table of elements Gene family,

Family (TV Series 1976–1980)

The family is stressed out and Kate is nervous as she must continue to wait for news from the doctor on Monday, whether or not she has cancer.

10.

thefamily.co

thefamily.co/

The Family: Building Ambitious Startups

The Family selects 50 startups from around the world. we provide everything you need to build a scalable business: advice, mindset, network & a world-class