NCT06430203

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
29mo left

Started Sep 2024

Longer than P75 for not_applicable diabetes-mellitus

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Sep 2028

First Submitted

Initial submission to the registry

May 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

May 16, 2024

Last Update Submit

May 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diabetes Distress

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

    0,6 and 12 months

Secondary Outcomes (9)

  • Global Distress

    0,6 and 12 months

  • Resilience-Children

    0,6 and 12 months

  • Resilience-Adults

    0,6 and 12 months

  • Body Mass Index

    0 and 12 months

  • Hemoglobin A1c

    0 and 12 months

  • +4 more secondary outcomes

Study Arms (1)

Peer-mentoring

EXPERIMENTAL

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

Behavioral: Peer mentoring

Interventions

Peer mentoringBEHAVIORAL

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.

Peer-mentoring

Eligibility Criteria

Age10 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Age \> 29 years old Not at risk of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Romina Pace

    MUHC-RI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 28, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share