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. (AHEAD Program)

Achieving Health in Emerging Adults With Diabetes (AHEAD) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1 Diabetes
• Intervention / Treatment: Behavioral: AHEAD Program

Detailed Description

Many emerging adults with type 1 diabetes find it difficult to maintain their blood glucose levels within the recommended range most of the time. This can increase their risk for serious short- and long-term diabetes-related health problems. Managing diabetes becomes especially difficult during the transition from pediatric care to adult care when emerging adults are expected to manage their condition on their own.

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.

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Loots, MPH, MSW; Phone Number: 206-884-4488; Email: beth.loots@seattlechildrens.org
• Study Contact Backup: Name: Faisal S Malik, MD, MSc; Phone Number: 604-875-2117; Email: faisal.malik@bcchr.ca

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Seattle Children's
      • Contact: Beth Loots, MPH, MSW; Phone Number: 206-884-4488; Email: beth.loots@seattlechildrens.org
      • Principal Investigator: Catherine Pihoker, MD
      • Contact: Tian Westland, BS; Phone Number: 206-884-2528; Email: tian.westland@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 16-19 years of age
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:

1. Have had a pilot program AHEAD clinic visit
2. Most recent Usual Care diabetes visit was with a current AHEAD provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual Care; Usual Care participants will receive diabetes care as currently being provided by their primary medical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (HbA1c)	HbA1c laboratory measurement.	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time In Ranges	Continuous glucose monitor sensor glucose measurements that are in range (70-180 mg/dL), above range (>180 mg/dL), and below range (<70 mg/dL).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Distress	Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (score: 14-84).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes-Specific Health Care Transition Readiness	Diabetes-specific health care transition readiness will be assessed with the Readiness Assessment of Emerging Adults with Type 1 Diabetes tool. Higher scores (mean topic area score: 1-5) indicate higher diabetes-specific transition readiness.	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
General Health Care Transition Readiness	General health care transition readiness will be assessed with the Transition Readiness Assessment Questionnaire. Higher scores (mean topic area score: 1-5) indicate higher transition readiness.	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Family Conflict	Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (score: 19-57).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Relatedness	Relatedness will be measured using the Health Care Climate Questionnaire. Higher scores indicate more supportive health care practitioner(s) (score: 15-105).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Autonomy Treatment Self-Regulation Questionnaire	Autonomy will be measured using the Treatment Self-Regulation Questionnaire. Higher scores indicate higher autonomy (score: 15-105).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Disordered eating	Disordered eating will be measured using the Disordered Eating Problem Survey - Revised. Higher scores indicate increase disordered eating behaviors (score: 0-80).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Depression	Depression will be measured using the Patient Health Questionnaire-9. Higher scores indicate higher depression severity (score: 0-27).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Generalized Anxiety	Anxiety will be measured using the Generalized Anxiety Disorder-7 questionnaire. Higher scores indicate higher severity of anxiety (score: 0-21).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Social needs	Social needs will be measured using the social needs questionnaire. Endorsement of financial insecurity, food insecurity, transportation challenges, and housing insecurity, will indicate higher social need(s) (score: N/A).	From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Washington; Seattle Children's Hospital; Kaiser Permanente; Breakthrough T1D
• Investigators: Principal Investigator: Faisal S Malik, MD, MSc, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Young adult; Diabetes distress; Diabetes self-management; Transition readiness; Patient transfer; Emerging adult; Health care transition
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: H25-03574; 4-SRA-2024-1580-M-B (Other Grant/Funding Number: Breakthrough T1D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (OpenScience Framework: https://osf.io/). To address privacy and confidentiality concerns, sharing of data generated will be limited to de-identified data at the aggregate level.
• IPD Sharing Time Frame: Data requests can be submitted at the end of the funding period and the data will be made accessible for up to 10 years.
• IPD Sharing Access Criteria: Access, distribution, and reuse of the data will require approval from study investigators.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No