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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-16
SponsorBaylor College of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from Baseline to 12 weeks post-intervention

Secondary outcomes

1

Hemoglobin A1c

Type 2 diabetes risk will be assessed using a point of care multi-assay analyzer, the Afinion 2 analyzer.

Time frame
Baseline and changes at 12-weeks post intervention
2

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.

Time frame
Baseline and at 12-weeks post-intervention
3

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.

Time frame
Baseline and at 12-weeks post-intervention

Other outcomes

1

Autonomous Motivation

Autonomous motivation for physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire. Both instruments have been validated among adolescents.

Time frame
Baseline and at 12-weeks post-intervention
2

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.

Time frame
Baseline and at 12-weeks post-intervention.

Sponsors and contacts

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