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.
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of British Columbia
- Study ID
- NCT07292558
- Status
- Recruiting
Conditions
- Diabetes Mellitus, Type 1 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - 19 Years
- Healthy Volunteers
- Not accepted
Interventions
- AHEAD Program — BEHAVIORALParticipants 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.
Study Details
The goal of this study is to determine whether the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program helps emerging adults with type 1 diabetes improve their blood glucose management during the transition from pediatric to adult care. 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.
Key Dates
- Start date
- Dec 15, 2025
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 306 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AHEAD ProgramAHEAD 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.
- No Intervention: Usual CareUsual Care participants will receive diabetes care as currently being provided by their primary medical team.
Primary Outcome Measure
Hemoglobin A1c (HbA1c) [ Time Frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). ]
Central Contacts
- Beth Loots, MPH, MSW206-884-4488
- Faisal S Malik, MD, MSc604-875-2117
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Seattle Children's | Seattle | Washington | 98101 | Catherine Pihoker, MD (PRINCIPAL_INVESTIGATOR) |
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