Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-17 @ 9:40 PM
Study NCT ID:
NCT06430203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Distress', 'timeFrame': '0,6 and 12 months', 'description': 'Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress'}], 'secondaryOutcomes': [{'measure': 'Global Distress', 'timeFrame': '0,6 and 12 months', 'description': '0 item Kessler Psychological Distress scale (K10), from 10-50, the higher the score the greater the global distress.'}, {'measure': 'Resilience-Children', 'timeFrame': '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-Adults', 'timeFrame': '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': 'Body Mass Index', 'timeFrame': '0 and 12 months', 'description': 'Weight (kg)/\\[Height(m)\\]\\^2'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '0 and 12 months', 'description': 'Percent HbA1c'}, {'measure': 'urine albumin to creatine ratio', 'timeFrame': '0 and 12 months', 'description': 'mg/mmol'}, {'measure': 'low density lipoprotein', 'timeFrame': '0 and 12 months', 'description': 'mmol/L'}, {'measure': 'Blood pressure', 'timeFrame': '0 and 12 months', 'description': 'mmHg'}, {'measure': 'Lifestyle questionnaire', 'timeFrame': '0 and 12 months', 'description': 'Developed by Cree Board of health to assess diet and physical activity. Not a scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Distress, Emotional']}, 'descriptionModule': {'briefSummary': '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.\n\n* Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?\n* What is it like for Indigenous youth and young adults to be live with diabetes?\n* Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?\n* 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.\n\nResearchers 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\n\nParticipants will:\n\n* Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes\n* Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors\n* Complete questionnaires on distress, resilience, and lifestyle every 6 months.\n* Participate in Photovoice workshops to share their stories through pictures.', 'detailedDescription': '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.\n\nPeer 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 10-29 years old Clinical diagnosis of diabetes or gestational diabetes\n\nExclusion Criteria:\n\nAge \\> 29 years old Not at risk of diabetes'}, 'identificationModule': {'nctId': 'NCT06430203', 'briefTitle': 'Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program', 'orgStudyIdInfo': {'id': '2025-10728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-mentoring', 'description': 'Peer-mentoring which will include land based activities, nutrition and physical activity teaching.', 'interventionNames': ['Behavioral: Peer mentoring']}], 'interventions': [{'name': 'Peer mentoring', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Peer-mentoring']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sahar Fazeli', 'role': 'CONTACT', 'email': 'sahar.fazeli@mcgill.ca', 'phone': '(438) 860-6079'}], 'overallOfficials': [{'name': 'Romina Pace', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUHC-RI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Romina Pace', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}