Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, R3E 3P4, Canada
Location contact
Brandy A Wicklow, MD, MSc
CONTACT
Research Coordinator
CONTACT
NCT Number: NCT07692321
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.
Trial opening soon.
Get NotifiedUp to 18 year
All sexes
Observational
Winnipeg, Manitoba, R3E 3P4, Canada
Brandy A Wicklow, MD, MSc
CONTACT
Research Coordinator
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the breastfeeding program:
Exclusion criteria
from the breastfeeding program:
Inclusion criteria
for the CGM pro
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.
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
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 aged 4-5 years to encourage traditional nutrition and activities to maintain wellness.
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).
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.
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.
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).
Time frame: 3 years
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
Time frame: 3 years
Time frame: 3 years
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Brandy A Wicklow, MD, MSc
CONTACT
Elizabeth AC Sellers, MD, MSc
CONTACT
University of Manitoba
Other
Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.
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