Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes

NCT07692321 | Not Yet Recruiting

• 1 other identifier: 5308
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective: to co-design and implement targeted and timely community led strategies to improve the health of the Next Generation and end the intergenerational impact of T2D in this population.

Conditions

Type 2 Diabetes; Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (2)

• Obesity

  Development of obesity defined by the International task force on obesity cut offs for age and gender.

  18 years

• Type 2 Diabetes

  Development of type 2 diabetes defined by diagnostic criteria in the Canadian Diabetes association 2008 guidelines in childhood (≤ 7 years) or adolescence (12-16 years).

  18 years

Study Arms (3)

Co-develop and implement a community-based perinatal education and support program using navigators

ACTIVE COMPARATOR

The implementation of a community-based navigator to facilitate multiple points of pre and post-partum contact as well as individualized connection to preexisting and co-developed urban and northern pre- and post-natal supports, will increase rates of initiation and duration (≥6 month) of breastfeeding in the NextGen mothers from 58% to ≥75%.

Behavioral: Breastfeeding and perinatal education and support

Extend the scope of the NextGen Cohort

ACTIVE COMPARATOR

Community based point of care HbA1c testing will improve access to annual screening for pre-diabetes and diabetes in the Next Gen Cohort. CGM can detect early dysglycemia (below the threshold for the diagnosis of prediabetes) in young children at high risk for childhood-onset T2D. In addition, we hypothesize that CGM use will be well tolerated and feasible in young children.

Device: Purchasing HbA1c machines for communities; Device: Continuous Glucose Monitoring

Co-develop and implement community led land-based programming for parent(s) and preschool children

ACTIVE COMPARATOR

Land-based community programming for caregivers and children aged 4-5 years is feasible and will encourage healthy nutrition choices and physical activity. Ultimately, we hypothesize that this will improve the health and well-being of this high-risk population and improve cardiometabolic health.

Behavioral: Land-based Wellness Programming

Interventions

Breastfeeding and perinatal education and support BEHAVIORAL

Co-develop and implement a community-based perinatal education and support program using navigators to support breast feeding, maternal nutrition and activity, and early infancy/childhood nutrition and activity.

Co-develop and implement a community-based perinatal education and support program using navigators

Purchasing HbA1c machines for communities DEVICE

This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.

Extend the scope of the NextGen Cohort

Continuous Glucose Monitoring DEVICE

We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.

Extend the scope of the NextGen Cohort

Land-based Wellness Programming BEHAVIORAL

Co-develop and implement community led land-based programming for parent(s) and preschool children aged 4-5 years to encourage traditional nutrition and activities to maintain wellness.

Co-develop and implement community led land-based programming for parent(s) and preschool children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women with type 2 diabetes, gestational diabetes, or no diabetes.
• From self-identified Indigenous heritage (e.g., Cree, Oji-Cree, Métis, Anishinaabe, etc.).
• Are delivering and residing in Manitoba.
• Mother/Father and children must be biological family members.

You may not qualify if:

• Mothers or children with type 1 diabetes.
• Residing outside of Manitoba.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Children's Hospital Research Institute of Manitoba: collaborator

Study Sites (1)

Children's Hospital Research Institute of Manitoba/University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Links

• Website that has all the current projects that deal with diabetes.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes, Gestational

Interventions

Lactation; Palliative Care; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Brandy A Wicklow, MD, MSc

  University of Manitoba, Children's Hospital Research Institute of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandy A Wicklow, MD, MSc

CONTACT

204-787-1222; bwicklow@hsc.mb.ca

Elizabeth AC Sellers, MD, MSc

CONTACT

204-787-3011; esellers@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)