Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breastfeeding and perinatal education and support, Purchasing HbA1c machines for communities, Continuous Glucose Monitoring, Land-based Wellness Programming.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Gestational Diabetes Mellitus (GDM). Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.
Overview
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.
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Proportion of mothers who initiate breastfeeding [Time frame: 3 years]
- Number of eligible children in the NextGen Cohort screened per community [Time frame: 3 years]
- Percentage of sensor time with glucose > 7.8 mmol/L [Time frame: 3 years]
- Number of times the land-based wellness program ran [Time frame: 3 years]
- Number of children who attend the land-based wellness programming [Time frame: 3 years]
- Number of young adult leaders hired for the land-based wellness program [Time frame: 3 years]
Secondary outcome measures (3)
- Number of mothers who enroll and participate in the breastfeeding navigator-based program [Time frame: 3 years]
- Number classes attended by mothers who participate in the breastfeeding navigator-based program [Time frame: 3 years]
- Qualitative review of the land-based wellness program [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Children's Hospital Research Institute of Manitoba/University of Manitoba — Winnipeg
Identifiers
NCT: NCT07692321 · 5308