Recruiting

Behavioral Intervention

Sponsor:

Baylor College of Medicine

Code:

NCT06014879

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

Type 1 Doing Well (T1DW) Program

Diabetes-Related Information and Resources Program

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06014879

Start date

Oct 22, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Type 1 Doing Well (T1DW) Program

Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the T1DW Program at the orientation session, parents and youth will receive an overview of the web-based mobile application and intervention activities that they will engage with for 6 months. The app-based intervention activities include brief daily use of the app for parents to recognize and reinforce their child's positive diabetes-related behaviors, brief weekly activities for parents and youth to reflect on and discuss what the child has done well for diabetes, family diabetes goal-setting, and videos for parents and youth about living well with T1D. Parents and youth will also engage in a brief strengths-based conversation with their diabetes care provider at one medical appointment during the study period.

active comparator: Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)

Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the EUC Program at the orientation session, parents and youth will receive monthly email handouts with diabetes-related information and resources for 6 months.

Interventions

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.

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.

Primary outcome measure

  • Demographic and Medical Information Questionnaire [ Time Frame: Baseline ]
  • Glycemic Control - HbA1c [ Time Frame: Baseline, 6 months, 12 months ]
  • Glycemic Control - time-in-range [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
  • Adherence - Self-Care Inventory 2 (SCI-2) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
  • Health-Related Quality of Life (HRQOL) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

Central Contacts and Locations

Central contacts

Marisa Hilliard, PhD

832-824-7209marisa.hilliard@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Marisa Hilliard, PhD

832-824-7209marisa.hilliard@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • type 1 diabetes
  • youth
  • adolescent
  • child
  • positive psychology
  • mhealth
  • ehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-18.