## Protocol Section
### Identification Module
**NCT ID:** NCT06430203

**Brief Title:** Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program

**Official Title:** Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program

#### Organization Study ID Info
**ID:** 2025-10728
#### Organization
**Class:** OTHER
**Full Name:** McGill University Health Centre/Research Institute of the McGill University Health Centre
### Status Module
#### Completion Date
**Date:** 2028-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** McGill University Health Centre/Research Institute of the McGill University Health Centre

#### Responsible Party

**Investigator Affiliation:** McGill University Health Centre/Research Institute of the McGill University Health Centre

**Investigator Full Name:** Romina Pace

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

- Distress, Emotional

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Peer-mentoring which will include land based activities, nutrition and physical activity teaching.

**Intervention Names:**

- Behavioral: Peer mentoring

**Label:** Peer-mentoring

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Peer-mentoring

**Description:** 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.

**Name:** Peer mentoring

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress

**Measure:** Diabetes Distress

**Time Frame:** 0,6 and 12 months

#### Secondary Outcomes

**Description:** 0 item Kessler Psychological Distress scale (K10), from 10-50, the higher the score the greater the global distress.

**Measure:** Global Distress

**Time Frame:** 0,6 and 12 months

**Description:** 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

**Measure:** Resilience-Children

**Time Frame:** 0,6 and 12 months

**Description:** Adult Resilience Measure-Revised (ARM-R), for those \> 18 years. Scale from 17-85, the higher the score the greater the resilience

**Measure:** Resilience-Adults

**Time Frame:** 0,6 and 12 months

**Description:** Weight (kg)/\[Height(m)\]\^2

**Measure:** Body Mass Index

**Time Frame:** 0 and 12 months

**Description:** Percent HbA1c

**Measure:** Hemoglobin A1c

**Time Frame:** 0 and 12 months

**Description:** mg/mmol

**Measure:** urine albumin to creatine ratio

**Time Frame:** 0 and 12 months

**Description:** mmol/L

**Measure:** low density lipoprotein

**Time Frame:** 0 and 12 months

**Description:** mmHg

**Measure:** Blood pressure

**Time Frame:** 0 and 12 months

**Description:** Developed by Cree Board of health to assess diet and physical activity. Not a scale

**Measure:** Lifestyle questionnaire

**Time Frame:** 0 and 12 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 29 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sahar.fazeli@mcgill.ca

**Name:** Sahar Fazeli

**Phone:** (438) 860-6079

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** MUHC-RI

**Name:** Romina Pace

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-31
