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

ConditionsType 2 DiabetesGestational Diabetes Mellitus (GDM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Parents or children with type 1 diabetes.

Residing outside of Manitoba.

Trial population

The Next Generation Cohort (NextGen) is an established longitudinal birth cohort in Manitoba of First Nations mothers and their offspring exposed to diabetes in utero (PGDM or GDM) and a non-exposed comparator population designed to discover the mechanisms underpinning the increased risk of childhood onset T2D in children exposed to diabetes in utero. We have developed a platform of research based on pre and post-natal measures in collaboration with strong community partnerships. The next natural extension of the NextGen Cohort study is to pilot interventions to decrease the rates of T2D in the offspring. The current project focuses on First Nations mothers and offspring from the four Asinininew Island Lake First Nations: Garden Hill, Red Sucker Lake, St. Theresa Point, and Wasagamach.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Breastfeeding and perinatal education and support

    Behavioral

    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.

  • Purchasing HbA1c machines for communities

    Device

    This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.

  • Continuous Glucose Monitoring

    Device

    We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.

  • Land-based Wellness Programming

    Behavioral

    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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Co-develop and implement a community-based perinatal education and support program using navigators1 intervention
Group B: Extend the scope of the NextGen Cohort2 interventions
Group C: Co-develop and implement community led land-based programming for parent(s) and preschool children1 intervention

Trial outcomes

Primary outcomes

1

Proportion of mothers who initiate breastfeeding

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
2

Number of eligible children in the NextGen Cohort screened per community

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
3

Percentage of sensor time with glucose > 7.8 mmol/L

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
4

Number of times the land-based wellness program ran

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

Secondary outcomes

1

Number of mothers who enroll and participate in the breastfeeding navigator-based program

Time frame
3 years
2

Number classes attended by mothers who participate in the breastfeeding navigator-based program

Time frame
3 years
3

Qualitative review of the land-based wellness program

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Children's Hospital Research Institute of Manitoba

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: