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

NCT06014879 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Type 1 Doing Well (T1DW) Program

Parent and youth will each have access to a version of the app. The study app activities include parents and youth: * noticing what the youth does well for diabetes; * setting and tracking a family diabetes goal in the app; and * having a weekly meeting to review what the youth is doing well with diabetes and progress on the family diabetes goal. Parents and youth will also have access to age-appropriate libraries of videos with diabetes-specific content. Parents and youth will also have a conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.

OTHER

Diabetes-Related Information and Resources Program

Parent and youth will receive diabetes-related information and resources in the form of electronic handouts. They will receive one handout per month by email during the 6-month intervention period. These handouts include a variety of diabetes-related topics curated by the study team. Handouts will not include any specific information about the youth's health.

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Marisa Hilliard, PhD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014879 on ClinicalTrials.gov