Gestational Diabetes Mellitus (GDM), Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALBreastfeeding 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.
DEVICEPurchasing HbA1c machines for communities
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
DEVICEContinuous Glucose Monitoring
We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.
BEHAVIORALLand-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.
Sponsors
University of Manitoba
Children's Hospital Research Institute of Manitoba
Canadian Institutes of Health Research (CIHR)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of mothers who initiate breastfeeding | 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 | 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 | 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 | 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 | 3 years | — |
| Number of young adult leaders hired for the land-based wellness program | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Canada
Contacts
CONTACTBrandy A Wicklow, MD, MSc
CONTACTElizabeth AC Sellers, MD, MSc
PRINCIPAL_INVESTIGATORBrandy A Wicklow, MD, MSc
University of Manitoba, Children's Hospital Research Institute of Manitoba
Outcome results
None listed