NCT06943001 · Baylor College of Medicine
Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents
(Fit24+)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Feasibility
Time frame: Change from Baseline to 12 weeks post-intervention
Feasibility is the primary outcome and will be evaluated using a priori criteria. Recruitment and Data Collection criteria will assess the feasibility of recruiting and retaining participants from community clinics. This will provide information on the availability of high-risk adolescents in community clinics and the feasibility of recruiting and engaging adolescents from this setting. The integrity of Study Protocol criteria will be used to identify the feasible and acceptable intervention doses. Technical Issues criteria will assess the feasibility of using Learnworlds, a Fitbit, and text messaging. Fidelity will be assessed as a team member will observe 75% of nutrition sessions and will complete fidelity checklists. Satisfaction will assess program acceptability. If feasibility criteria are satisfied it will be used to develop a future R01.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations