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

Sponsor
University of Manitoba
Study ID
NCT07692321
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Accepted

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.
  • Purchasing HbA1c machines for communities — DEVICE
    This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
  • Continuous Glucose Monitoring — DEVICE
    We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen 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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Active Comparator: Co-develop and implement a community-based perinatal education and support program using navigators
    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%.
  • Active Comparator: Extend the scope of the NextGen Cohort
    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.
  • Active Comparator: Co-develop and implement community led land-based programming for parent(s) and preschool children
    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.

Primary Outcome Measure

Obesity [ Time Frame: 18 years ]

Central Contacts

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