Type 2 DiabetesNCT07692321
Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes
An observational study of Type 2 Diabetes and Gestational Diabetes Mellitus (GDM), run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Breastfeeding and perinatal education and support, Purchasing HbA1c machines for communities and Continuous Glucose Monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2026to 31 Mar 2031
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Parents or children with type 1 diabetes.
- Residing outside of Manitoba.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Brandy A Wicklow, MD, MSc, 204781222, bwicklow@hsc.mb.ca
Research Coordinator, 2042723064, NextGenStudy@chrim.ca
About this study
Official title: Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.
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.
Read the 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.
- Being tested
- Breastfeeding and perinatal education and support, Purchasing HbA1c machines for communities, Continuous Glucose Monitoring, Land-based Wellness Programming
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding and perinatal education and supportBehavioural
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 communitiesDevice
This will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D.
Continuous Glucose MonitoringDevice
We will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort.
Land-based Wellness ProgrammingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Behavioral: Breastfeeding and perinatal education and support | |
| 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. Receives: Device: Purchasing HbA1c machines for communities; Device: Continuous Glucose Monitoring | |
| 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. Receives: Behavioral: Land-based Wellness Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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).
Measured: 3 years
Number of children who attend the land-based wellness programming
Measured: 3 years
Number of young adult leaders hired for the land-based wellness program
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
Measured: 3 years
Secondary outcomes (3)
Number of mothers who enroll and participate in the breastfeeding navigator-based program
Measured: 3 years
Number classes attended by mothers who participate in the breastfeeding navigator-based program
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Brandy A Wicklow, MD, MSc, Principal investigator, University of Manitoba, Children's Hospital Research Institute of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692321
- Sponsor's protocol ID
- 5308
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In cooperation with OCAP principles.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes: The Next Generation Birth Cohort.
- ClinicalTrials.gov ID
- NCT07692321
- Acronym / sponsor ID
- 5308
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Canadian Institutes of Health Research (CIHR)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-develop and implement a community-based perinatal education and support program using navigators | – | Behavioral: Breastfeeding and perinatal education and supportThe 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%. |
| Extend the scope of the NextGen Cohort | – | Device: Purchasing HbA1c machines for communities, Device: Continuous Glucose MonitoringCommunity 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. |
| Co-develop and implement community led land-based programming for parent(s) and preschool children | – | Behavioral: Land-based Wellness ProgrammingLand-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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Parents or children with type 1 diabetes.
- Residing outside of Manitoba.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding and perinatal education and supportCo-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. | Behavioural | Co-develop and implement a community-based perinatal education and support program using navigators |
| Purchasing HbA1c machines for communitiesThis will allow study participants to conduct earlier and more frequent screening for early dysglycemia, prediabetes and T2D. | Device | Extend the scope of the NextGen Cohort |
| Continuous Glucose MonitoringWe will investigate the use of continuous glucose monitoring (CGM) to detect early dysglycemia in the Next Gen cohort. | Device | Extend the scope of the NextGen Cohort |
| Land-based Wellness ProgrammingCo-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. | Behavioural | Co-develop and implement community led land-based programming for parent(s) and preschool children |
Primary outcome
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
3 secondary outcomes
Number of mothers who enroll and participate in the breastfeeding navigator-based program
Time frame: 3 years
Number classes attended by mothers who participate in the breastfeeding navigator-based program
Time frame: 3 years
Qualitative review of the land-based wellness program
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Website that has all the current projects that deal with diabetes.Link provided by the sponsor.
- Individual participant dataSharing planned: No. In cooperation with OCAP principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandy A Wicklow, MD, MSc principal investigator
University of Manitoba, Children's Hospital Research Institute of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Gestational Diabetes Mellitus (GDM), run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandy A Wicklow, MD, MSc (204-787-1222, bwicklow@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mothers who initiate breastfeeding (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.