About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fit24+
BehavioralThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility
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.
Secondary outcomes
Hemoglobin A1c
Type 2 diabetes risk will be assessed using a point of care multi-assay analyzer, the Afinion 2 analyzer.
Body mass index
Height and weight will be measured to the nearest 0.1cm and 0.1 kg, and used to calculate BMI% and BMI will be calculated as the percentage over the 95th percentile.
Physical Activity
Physical Activity (PA) will be assessed using a hip-worn accelerometer (wGT3X-BT, Actigraph). Participants will wear the accelerometer during wake time hours for 7 days. Participants will receive daily text messages to promote compliance in device wear. A valid day of wear will be defined as ≥10 hours of wear on ≥4 days, one of which has to be a weekend day.
Other outcomes
Autonomous Motivation
Autonomous motivation for physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire. Both instruments have been validated among adolescents.
Physical Activity identity
Youth will complete the physical activity identity survey to understand the intervention's ability to improve one's belief that they can live an active life.
Sponsors and contacts
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