Recruiting

Telehealth Diabetes

Sponsor:

Baylor College of Medicine

Code:

NCT06943001

Conditions

Obesity and Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 14 - 16

Healthy Volunteers: Accepted

Interventions

Fit24+

Study Details

Brief summary:

Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.

Conditions

Obesity and Type 2 Diabetes

Study ID

NCT06943001

Start date

Apr 12, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 16

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Self-report as Hispanic
  • obese, defined as body mass index percentile (BMI%) ≥ 95th percentile
  • ages of 12-16 years
  • owns his or her own cellphone

Exclusion Criteria:

  • Taking a medication (i.e. steroids) or diagnosed with a condition (i.e. sleep apnea) that influences activity, sleep, and/or cognition
  • Recent hospitalization or injury that prevents normal physical activity
  • Pregnant
  • Currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit
  • Taking medications or diagnosed with a condition that influences activity, glucose metabolism, and/or cognition.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Nutrition Education: There are 12 pre-recorded nutrition and well-being sessions in Spanish and English lasting 20-40 minutes and hosted on an elearning platform, Learnworlds. This is a secure platform and each participant and their family members will have a secure, unique, password protected login. The platform includes a discussion board to share challenges and successes in behavior change, a recipes tab, and message system to ask instructors questions or report technical issues. Participants will receive a Fitbit Charge and access to a chatbot developed by Mobile Coach to assist youth in setting behavioral goals and planning opportunities to be active or to improve sleep behaviors. Mid-week texts will emphasize competence by acknowledging progression towards goals, providing evidence-based strategies for increasing PA, and reinforcing content from nutrition sessions. End of week texts will provide feedback on goal attainment.

no intervention: Control

Youth in the control will receive a handout on diet and PA guidelines . Control youth will be given access to the nutrition education website after their participation as a control for 12-weeks. No additional data will be collected on control youth beyond the 12 week intervention period.

Interventions

Fit24+

This is a digital diabetes prevention program for adolescents that leverages a Fitbit device, rule-based chatbot, and eLearning platform to deliver a comprehensive nutrition and physical activity lifestyle intervention to Hispanic adolescents with obesity.

Primary outcome measure

  • Feasibility [ Time Frame: Change from Baseline to 12 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Erica Soltero, PhD

402-910-0832soltero@bcm.edu

Locations

USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77003

Contacts

Erica Soltero, PhD

402-910-0832soltero@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • adolescents health
  • wearable sensors
  • user-centered design approac
  • T2D prevention

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 2026-07-07.