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

30 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Brandy A Wicklow, MD, MSc
  • Numero di telefono: 204-787-1222
  • Email: bwicklow@hsc.mb.ca

Backup dei contatti dello studio

  • Nome: Elizabeth AC Sellers, MD, MSc
  • Numero di telefono: 204-787-3011
  • Email: esellers@hsc.mb.ca

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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%.
Comportamentale: 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.
Dispositivo: Purchasing HbA1c machines for communities
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
Dispositivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of mothers who initiate breastfeeding
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3 years
3 years
Number of young adult leaders hired for the land-based wellness program
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of mothers who enroll and participate in the breastfeeding navigator-based program
Lasso di tempo: 3 years
3 years
Number classes attended by mothers who participate in the breastfeeding navigator-based program
Lasso di tempo: 3 years
3 years
Qualitative review of the land-based wellness program
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manitoba

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 agosto 2026

Completamento primario (Stimato)

30 giugno 2030

Completamento dello studio (Stimato)

31 marzo 2031

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5308

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

In cooperation with OCAP principles.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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