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NCT Number: NCT07292558

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.

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16-19 years of age
  • Have had type 1 diabetes ≥ 12 months
  • Had a recent HbA1c ≥7.0%
  • Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
  • Are able to complete written surveys
  • Will be able to receive clinical care in WA State for the next 2 years

Exclusion criteria

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

Treatment and study plan

AHEAD Program

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    HbA1c laboratory measurement.

Secondary outcomes

  1. Time In Ranges

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    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).

  2. Diabetes Distress

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (score: 14-84).

  3. Diabetes-Specific Health Care Transition Readiness

    Time frame: 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 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.

  4. General Health Care Transition Readiness

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    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.

  5. Diabetes Family Conflict

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (score: 19-57).

  6. Relatedness

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Relatedness will be measured using the Health Care Climate Questionnaire. Higher scores indicate more supportive health care practitioner(s) (score: 15-105).

  7. Autonomy Treatment Self-Regulation Questionnaire

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Autonomy will be measured using the Treatment Self-Regulation Questionnaire. Higher scores indicate higher autonomy (score: 15-105).

  8. Disordered eating

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Disordered eating will be measured using the Disordered Eating Problem Survey - Revised. Higher scores indicate increase disordered eating behaviors (score: 0-80).

  9. Depression

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Depression will be measured using the Patient Health Questionnaire-9. Higher scores indicate higher depression severity (score: 0-27).

  10. Generalized Anxiety

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    Anxiety will be measured using the Generalized Anxiety Disorder-7 questionnaire. Higher scores indicate higher severity of anxiety (score: 0-21).

  11. Social needs

    Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Loots, MPH, MSW

CONTACT

[email protected]

206-884-4488

Faisal S Malik, MD, MSc

CONTACT

[email protected]

604-875-2117

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Breakthrough T1D
  • Kaiser Permanente
  • Seattle Children's Hospital
  • University of Washington

Registry information

Official study title

Achieving Health in Emerging Adults With Diabetes (AHEAD) Study

Acronym: AHEAD Program

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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