Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Manitoba
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Obesity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Purchasing HbA1c machines for communities (Device)
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%.
Intervention: Breastfeeding and perinatal education and support (Behavioral)
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.
Intervention: Continuous Glucose Monitoring (Device)
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.
Intervention: Land-based Wellness Programming (Behavioral)
Outcomes
Primary Outcomes
Obesity
Time Frame: 18 years
Development of obesity defined by the International task force on obesity cut offs for age and gender.
Type 2 Diabetes
Time Frame: 18 years
Development of type 2 diabetes defined by diagnostic criteria in the Canadian Diabetes association 2008 guidelines in childhood (≤ 7 years) or adolescence (12-16 years).
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).
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.
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.
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).
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
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
Secondary Outcomes
- Number of mothers who enroll and participate in the breastfeeding navigator-based program(3 years)
- Number classes attended by mothers who participate in the breastfeeding navigator-based program(3 years)
- Qualitative review of the land-based wellness program(3 years)