Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06943001

Recruiting nowNot applicableInterventional

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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 16 Years

SexAll

Healthy volunteersAccepted

ConditionObesity and Type 2 Diabetes

Full registry criteria

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.

Treatments and study arms

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.

Primary outcomes

FeasibilityChange 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine🇺🇸 Houston, Texas, United States

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Erica Soltero, PhDContact

Email · Call 402-910-0832