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

July 30, 2026 updated by: University of Manitoba

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Guided by gaps in knowledge and care identified by participant advisors, community, and First Nations leadership, the investigators have developed a multifaceted and multidisciplinary research program which leverages the existing NextGen Cohort to enhance metabolic screening and evaluate novel intervention strategies. With First Nations partners the investigators 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.

Study Type

Observational

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elizabeth AC Sellers, MD, MSc
  • Phone Number: 204-787-3011
  • Email: esellers@hsc.mb.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Children's Hospital Research Institute of Manitoba/University of Manitoba
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The Next Generation Cohort (NextGen) is an established longitudinal birth cohort in Manitoba of First Nations mothers and their offspring exposed to diabetes in utero (PGDM or GDM) and a non-exposed comparator population designed to discover the mechanisms underpinning the increased risk of childhood onset T2D in children exposed to diabetes in utero. We have developed a platform of research based on pre and post-natal measures in collaboration with strong community partnerships. The next natural extension of the NextGen Cohort study is to pilot interventions to decrease the rates of T2D in the offspring. The current project focuses on First Nations mothers and offspring from the four Asinininew Island Lake First Nations: Garden Hill, Red Sucker Lake, St. Theresa Point, and Wasagamach.

Description

Inclusion Criteria for the breastfeeding program:

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

Exclusion Criteria from the breastfeeding program:

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

Inclusion criteria for the CGM pro

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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%.
Behavioral: Breastfeeding and perinatal education and support
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.
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.
Device: Purchasing HbA1c machines for communities
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
Device: Continuous Glucose Monitoring
We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.
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.
Behavioral: Land-based Wellness Programming
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of mothers who initiate breastfeeding
Time Frame: 3 years
This will be for for both groups experiencing and not experiencing diabetes during the pregnancy, exclusivity of breastfeeding and breastfeeding continuation at 1, 3 and 6 months. In addition, we will examine the growth trajectories of infants who are breastfed and compare them to infants who are not breastfed (from historical NextGen Cohort follow up and the current project).
3 years
Number of eligible children in the NextGen Cohort screened per community
Time Frame: 3 years

This is a feasibility pilot to determine if participants will be screened more frequently once there are point of care HbA1C machines in each community.

Qualitative data on the feasibility and implementation of the screening program via interviews with the community health care workers and NextGen families to determine facilitators and barriers to screening in community and areas of improvement for the program.
3 years
Percentage of sensor time with glucose > 7.8 mmol/L
Time Frame: 3 years
This is to determine the feasibility of using CGM with 6 and 7 year old children. SD of sensor glucose levels (a summary measure of glycemic variability - amplitude, frequency and duration of fluctuation in glucose measurement) and 2. tolerability and feasibility of CGM use in this population.
3 years
Number of times the land-based wellness program ran
Time Frame: 3 years
Feasibility of establishing and implementing this program will be assessed by metrics including how often the program ran (bench marked against number of sessions planned), and number of children participating (benchmarked against number eligible).
3 years
Number of children who attend the land-based wellness programming
Time Frame: 3 years
3 years
Number of young adult leaders hired for the land-based wellness program
Time Frame: 3 years
We anticipate that another key outcome will be capacity building for young adult leaders who will work alongside Elders and develop skills in leadership, youth health and wellness, program evaluation, and land-based curriculum development
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mothers who enroll and participate in the breastfeeding navigator-based program
Time Frame: 3 years
3 years
Number classes attended by mothers who participate in the breastfeeding navigator-based program
Time Frame: 3 years
3 years
Qualitative review of the land-based wellness program
Time Frame: 3 years
Barriers and facilitators of program success will be co-determined by Anisininew leaders through the evaluative process, and may include qualitative interviews with family participants and leaders and/or sharing circles lead by Elders and Knowledge keepers.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

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

Investigators

  • Principal Investigator: Brandy A Wicklow, MD, MSc, University of Manitoba, Children's Hospital Research Institute of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In cooperation with OCAP principles.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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