Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06943001
Status
Recruiting
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Conditions

  • Obesity and Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
14 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • Fit24+ — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 12, 2025
Status verified
Apr 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USDA/ARS Children's Nutrition Research Center, Baylor College of MedicineHoustonTexas77003
Erica Soltero, PhD
[email protected]
402-910-0832

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By research site
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine· Houston, TX

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