Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.
NCT ID: NCT07292558
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
306 participants
INTERVENTIONAL
2025-12-15
2028-12-31
Brief Summary
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Participants will be randomized to receive Usual Care or the AHEAD Program, which provides tailored support to emerging adults to build autonomy and competence to facilitate independent diabetes management. Researchers will compare changes in glycemia and participant-reported outcomes between groups.
Detailed Description
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The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program was developed to support emerging adults with their transition to independence. It focuses on helping them build autonomy and competence needed to manage their diabetes independently. The program is based on self-determination theory and best practices for supporting successful health care transition to adult care.
In this study, 306 emerging adults will be randomly assigned to either the AHEAD Program or Usual Care arms. Participants will have 6 clinic visits and complete surveys prior to their clinic visits. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes every three months. Usual Care participants will continue to receive the diabetes care as they do currently every three months.
Researchers will evaluate changes in glycemia and participant-reported outcomes (e.g., diabetes distress, transition readiness). The study will also assess the cost and cost-effectiveness of AHEAD, as well as factors related to its implementation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AHEAD Program
AHEAD participants will receive support from a team of diabetes providers with expertise in supporting older adolescents and young adults who will work to build autonomy and competence needed to manage diabetes independently.
AHEAD Program
Participants will complete self-assessments around health care transition readiness and mental health prior to an AHEAD clinic visit. Emerging adults will then received tailored clinical support based on their self-assessments and work to build their autonomy and competence to manage their diabetes and health care independently with the support of their AHEAD providers.
Usual Care
Usual Care participants will receive diabetes care as currently being provided by their primary medical team.
No interventions assigned to this group
Interventions
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AHEAD Program
Participants will complete self-assessments around health care transition readiness and mental health prior to an AHEAD clinic visit. Emerging adults will then received tailored clinical support based on their self-assessments and work to build their autonomy and competence to manage their diabetes and health care independently with the support of their AHEAD providers.
Eligibility Criteria
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Inclusion Criteria
2. Have had type 1 diabetes ≥ 12 months
3. Had a recent HbA1c ≥7.0%
4. Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
5. Are able to complete written surveys
6. Will be able to receive clinical care in WA State for the next 2 years
Exclusion Criteria
2. Most recent Usual Care diabetes visit was with a current AHEAD provider
16 Years
19 Years
ALL
No
Sponsors
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Breakthrough T1D
OTHER
Seattle Children's Hospital
OTHER
University of Washington
OTHER
Kaiser Permanente
OTHER
University of British Columbia
OTHER
Responsible Party
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Faisal Malik
Principle Investigator
Principal Investigators
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Faisal S Malik, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Seattle Children's
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Beth Loots, MPH, MSW
Role: primary
Tian Westland, BS
Role: backup
Other Identifiers
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4-SRA-2024-1580-M-B
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H25-03574
Identifier Type: -
Identifier Source: org_study_id