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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Устройство Purchasing HbA1c machines for communities
  This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
• Устройство Continuous Glucose Monitoring
  We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.
• Поведенческое 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.

Первичные конечные точки

• Proportion of mothers who initiate breastfeeding [Срок оценки: 3 years]
• Number of eligible children in the NextGen Cohort screened per community [Срок оценки: 3 years]
• Percentage of sensor time with glucose > 7.8 mmol/L [Срок оценки: 3 years]
• Number of times the land-based wellness program ran [Срок оценки: 3 years]
• Number of children who attend the land-based wellness programming [Срок оценки: 3 years]
• Number of young adult leaders hired for the land-based wellness program [Срок оценки: 3 years]

Вторичные конечные точки (3)

• Number of mothers who enroll and participate in the breastfeeding navigator-based program [Срок оценки: 3 years]
• Number classes attended by mothers who participate in the breastfeeding navigator-based program [Срок оценки: 3 years]
• Qualitative review of the land-based wellness program [Срок оценки: 3 years]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Children's Hospital Research Institute of Manitoba/University of Manitoba — Winnipeg

Идентификаторы

NCT: NCT07692321 · 5308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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