NCT06014879Active, not recruiting
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 16 Aug 2023
- Start date
- 22 Oct 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Type 1 diabetes
- NCT number
- NCT06014879
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 22 Oct 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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,
- 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
Other
- Youth
- Being treated for:
- Study team learning of other involvement with the legal system during screening or recruitment
- For the Teen Videos:
Who the study is looking for
- 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
- self-reported type 1 diabetes diagnosis for ≥ 1 year,
- age 14-17 at consent,
- English fluency,
- living in the United States
- \- Provider at one of the sites' diabetes care centers
Criteria the registry did not label
- For Trial Participants -
Age in the registry: 10 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.