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NCT Number: NCT07692321

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Guided by gaps in knowledge and care identified by participant advisors, community, and First Nations leadership, we have developed a multifaceted and multidisciplinary research program which leverages the existing NextGen Cohort to enhance metabolic screening and evaluate novel intervention strategies. With our First Nations partners we will 1) Co-develop a perinatal support program led by a community-based navigator to support maternal and early childhood nutrition and activity, including breastfeeding supports, aimed at diabetes prevention, 2) Implement community-based early childhood screening for evidence of dysglycemia, and 3) Co-develop and implement a community led land-based program for children ages 4-5 years and their caregivers to encourage and educate about the benefits of traditional nutrition and activities to maintain wellness. In partnership with the Four Arrows Regional Health Authority (FARHA) and its four governing Anisininew First Nations in Manitoba, this program of research will address the lifecycle of intergenerational T2D by implementation of pre and post-natal/early childhood interventions in a population with the highest rates of childhood-onset T2D observed in the world (2).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Obesity

    Time frame: 18 years

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

  2. Type 2 Diabetes

    Time frame: 18 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Brandy A Wicklow, MD, MSc

CONTACT

[email protected]

204-787-1222

Elizabeth AC Sellers, MD, MSc

CONTACT

[email protected]

204-787-3011

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Children's Hospital Research Institute of Manitoba

Registry information

Official study title

Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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