Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes
2026년 7월 30일 업데이트: University of Manitoba
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
600
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Brandy A Wicklow, MD, MSc
- 전화번호: 204-787-1222
- 이메일: bwicklow@hsc.mb.ca
연구 연락처 백업
- 이름: Elizabeth AC Sellers, MD, MSc
- 전화번호: 204-787-3011
- 이메일: esellers@hsc.mb.ca
연구 장소
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 3P4
- Children's Hospital Research Institute of Manitoba/University of Manitoba
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연락하다:
- Brandy A Wicklow, MD, MSc
- 전화번호: 204781222
- 이메일: bwicklow@hsc.mb.ca
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연락하다:
- Research Coordinator
- 전화번호: 2042723064
- 이메일: NextGenStudy@chrim.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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%.
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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.
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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.
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of mothers who initiate breastfeeding
기간: 3 years
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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).
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3 years
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Number of eligible children in the NextGen Cohort screened per community
기간: 3 years
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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. |
3 years
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Percentage of sensor time with glucose > 7.8 mmol/L
기간: 3 years
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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.
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3 years
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Number of times the land-based wellness program ran
기간: 3 years
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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).
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3 years
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Number of children who attend the land-based wellness programming
기간: 3 years
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3 years
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Number of young adult leaders hired for the land-based wellness program
기간: 3 years
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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
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of mothers who enroll and participate in the breastfeeding navigator-based program
기간: 3 years
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3 years
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Number classes attended by mothers who participate in the breastfeeding navigator-based program
기간: 3 years
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3 years
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Qualitative review of the land-based wellness program
기간: 3 years
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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.
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3 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Brandy A Wicklow, MD, MSc, University of Manitoba, Children's Hospital Research Institute of Manitoba
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 31일
기본 완료 (추정된)
2030년 6월 30일
연구 완료 (추정된)
2031년 3월 31일
연구 등록 날짜
최초 제출
2026년 7월 2일
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 30일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 5308
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
In cooperation with OCAP principles.
약물 및 장치 정보, 연구 문서
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .