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EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Study acronym: EMPoWER
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  2. Eligibility criteria expanded, about 6 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Start date: Aug 7, 2023 to Oct 22, 2024 Enrollment target: 330 to 250 · Interventions: Diabetes Care Provider Intervention Delivery (Behavioral), Diabetes-Related Information and Resources Program (Other), Teen Videos… to Diabetes-Related Information and Resources Program (Other), Type 1 Doing Well (T1DW) Program (Behavioral) · Study description expanded, about 55 words · 2 morev4 Show 5 more changesShow less
    • Enrollment target: 330 to 250
    • Interventions: Diabetes Care Provider Intervention Delivery (Behavioral), Diabetes-Related Information and Resources Program (Other), Teen Videos… to Diabetes-Related Information and Resources Program (Other), Type 1 Doing Well (T1DW) Program (Behavioral)
    • Study description expanded, about 55 words
    • Study arms: 4 to 2
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: May 1, 2027 to Sep 30, 2027 Completion date: Jun 30, 2027 to Dec 31, 2027v3 Show 1 more changeShow less
    • Completion date: Jun 30, 2027 to Dec 31, 2027
  5. Enrollment target: 30 to 330 Primary endpoints: 1 to 5 · Primary completion date: Dec 31, 2026 to May 1, 2027 · Interventions: Teen Videos (Behavioral) to Diabetes Care Provider Intervention Delivery (Behavioral), Diabetes-Related Information and Resources Program (Other), Teen Videos… · 4 morev2 Show 7 more changesShow less
    • Primary endpoints: 1 to 5
    • Primary completion date: Dec 31, 2026 to May 1, 2027
    • Interventions: Teen Videos (Behavioral) to Diabetes Care Provider Intervention Delivery (Behavioral), Diabetes-Related Information and Resources Program (Other), Teen Videos…
    • Eligibility criteria expanded, about 251 words
    • Secondary endpoints expanded, about 39 words
    • Study description expanded, about 304 words
    • Study arms: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06014879
Lead Sponsor Baylor College of Medicine
Collaborators: Children's National Research Institute
Conditions Type 1 Diabetes
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov