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

NCT06943001 | Recruiting DMC

• 1 other identifier: H-50331
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Type 2 Diabetes

Keywords

adolescents health; wearable sensors; user-centered design approac; T2D prevention

Outcome Measures

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.

  Change from Baseline to 12 weeks post-intervention

Secondary Outcomes (3)

• Hemoglobin A1c

  Baseline and changes at 12-weeks post intervention

• Body mass index

  Baseline and at 12-weeks post-intervention

• Physical Activity

  Baseline and at 12-weeks post-intervention

Other Outcomes (2)

• Autonomous Motivation

  Baseline and at 12-weeks post-intervention

• Physical Activity identity

  Baseline and at 12-weeks post-intervention.

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Fit24+

Control

NO INTERVENTION

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.

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.

Intervention

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, 77003, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Erica Soltero, PhD

CONTACT

402-910-0832; soltero@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)