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

30. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

600

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Elizabeth AC Sellers, MD, MSc
  • Telefonnummer: 204-787-3011
  • E-mail: esellers@hsc.mb.ca

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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%.
Adfærdsmæssigt: 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.
Enhed: Purchasing HbA1c machines for communities
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
Enhed: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of mothers who initiate breastfeeding
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 years
3 years
Number of young adult leaders hired for the land-based wellness program
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of mothers who enroll and participate in the breastfeeding navigator-based program
Tidsramme: 3 years
3 years
Number classes attended by mothers who participate in the breastfeeding navigator-based program
Tidsramme: 3 years
3 years
Qualitative review of the land-based wellness program
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Manitoba

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

30. juni 2030

Studieafslutning (Anslået)

31. marts 2031

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5308

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

In cooperation with OCAP principles.

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