NCT06014879 EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
| NCT ID | NCT06014879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-10-22 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.
Eligibility Criteria
For Trial Participants - Inclusion Criteria: Youth * type 1 diabetes diagnosis per ADA criteria for at least 6 months, * age 10 to 13 years at consent, * English or Spanish fluency, * At least one hemoglobin A1c value ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026) * Patient at one of the participating study sites Parent/legal guardian of youth * Age at least 18 years old at time of consent, * English or Spanish fluency, * Consistent access to a mobile phone that has texting capabilities and a device with internet access Exclusion Criteria: Youth Being treated for: * a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis), * a major serious psychological or psychiatric condition, * a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes Parents/legal guardian of youth participant Being treated for: * a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis), * a major serious psychological or psychiatric condition, * a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes Other Exclusion Criteria * Plans to move diabetes care out of participating hospital site within next 6 months, * Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment, * Study team learning of other involvement with the legal system during screening or recruitment For the Teen Videos: Inclusion Criteria: * self-reported type 1 diabetes diagnosis for ≥ 1 year, * age 14-17 at consent, * English fluency, * living in the United States Exclusion Criteria: * major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation, * major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis). Diabetes Care Provider Participants Inclusion Criteria: \- Provider at one of the sites' diabetes care centers
Contact & Investigator
Marisa Hilliard, PhD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT06014879 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 99 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06014879 currently recruiting?
Yes, NCT06014879 is actively recruiting participants. Contact the research team at marisa.hilliard@bcm.edu for enrollment information.
Where is the NCT06014879 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06014879 clinical trial?
NCT06014879 is sponsored by Baylor College of Medicine. The principal investigator is Marisa Hilliard, PhD at Baylor College of Medicine. The trial plans to enroll 250 participants.
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