Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program

The goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes.

  • Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?
  • What is it like for Indigenous youth and young adults to be live with diabetes?
  • Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?
  • Can a peer-mentoring program lead to changes in lifestyle (diet, physical activity, substance use) and diabetes related clinical outcomes among Indigenous youth and young adults with diabetes.

Researchers will compare distress, resilience, lifestyles, and diabetes related clinical outcomes before participating in the peer-mentoring program and at 6 and 12 months into the program. Additionally, participants will be asked to share their journey with diabetes through photos throughout the program

Participants will:

  • Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes
  • Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors
  • Complete questionnaires on distress, resilience, and lifestyle every 6 months.
  • Participate in Photovoice workshops to share their stories through pictures.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

The rates of diabetes are increasing among youth and young adults. This rise is particularly steep among Indigenous peoples who also face high rates of depression and emotional distress due to the ongoing legacy of colonization resulting in systemic racism and intergenerational trauma. Diabetes care includes many aspects of self-care (checking sugar, taking medication, following exercise and diet advice), which is negatively impacted by emotional distress. The emotional distress specific to living with diabetes, known as diabetes distress (DD), is due to feeling overwhelmed by the demands of self-care, fears of complications, and guilt or shame over lifestyle choices. DD is known to be related to decreased wellbeing and poor diabetes control. The rate of DD has not been studied among Indigenous youth, nor have interventions aimed at reducing it to improve diabetes management.

Peer support has been shown to help empower youth and young adults by normalizing their experiences and providing a safe space to express themselves. In the Eeyou Istchee Cree community in Quebec, Jonathan Linton, an Indigenous young adult with diabetes, developed a program for youth with diabetes on management and self-care for diabetes that incorporates traditional elements. As he helps participants be more active and eat healthier, he supports them in their journey with diabetes and creates a safe space for them to voice concerns, easing their distress.

This research study will build on the initiative developed by Mr. Linton to create a community of peer-mentors to provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. To evaluate the program, a combination of questionnaires to assess changes in DD and other emotional factors, measures of diabetes outcomes (glycemia, blood pressure, weight), and Photovoice, a research tool that allows participants to use images to explain their experience with diabetes, will be used.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age 10-29 years old Clinical diagnosis of diabetes or gestational diabetes

Exclusion Criteria:

Age > 29 years old Not at risk of diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-mentoring
Peer-mentoring which will include land based activities, nutrition and physical activity teaching.
Indigenous young adult peer mentors who will develop and deliver the program based on needs and wants of our participants. The program will be built on their experience and ideas. They will be empowered to guide the program in the direction they see best for their communities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress
Time Frame: 0,6 and 12 months
Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress
0,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Distress
Time Frame: 0,6 and 12 months
0 item Kessler Psychological Distress scale (K10), from 10-50, the higher the score the greater the global distress.
0,6 and 12 months
Resilience-Children
Time Frame: 0,6 and 12 months
Child and Youth Resilience Measure-Revised (CYRM-R), for 10-18 years old. Scale from 17-85, the higher the score the greater the resilience
0,6 and 12 months
Resilience-Adults
Time Frame: 0,6 and 12 months
Adult Resilience Measure-Revised (ARM-R), for those > 18 years. Scale from 17-85, the higher the score the greater the resilience
0,6 and 12 months
Body Mass Index
Time Frame: 0 and 12 months
Weight (kg)/[Height(m)]^2
0 and 12 months
urine albumin to creatine ratio
Time Frame: 0 and 12 months
mg/mmol
0 and 12 months
low density lipoprotein
Time Frame: 0 and 12 months
mmol/L
0 and 12 months
Blood pressure
Time Frame: 0 and 12 months
mmHg
0 and 12 months
Hemoglobin A1c
Time Frame: 0 and 12 months
Percent HbA1c
0 and 12 months
Lifestyle questionnaire
Time Frame: 0 and 12 months
Developed by Cree Board of health to assess diet and physical activity. Not a scale
0 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Romina Pace, MUHC-RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-10728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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