Actively Recruiting

Phase Not Applicable
Age: 14Years - 16Years
All Genders
Healthy Volunteers
ID06943001

Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents with Obesity and Type 2 Diabetes

Led by Baylor College of Medicine · Updated on 2025-04-25

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Hispanic adolescents aged 12 to 16 years with obesity are disproportionately affected by type 2 diabetes (T2D). This research aims to adapt an evidence-based diabetes prevention program for delivery through telehealth and evaluate its feasibility among this population. Social determinants of health create barriers to traditional behavior change programs, and telehealth may help overcome challenges such as transportation and scheduling conflicts. The program includes 12 pre-recorded nutrition and well-being sessions in Spanish and English delivered via a secure eLearning platform called Learnworlds. Participants receive a Fitbit Charge device and access to a rule-based chatbot to support setting physical activity and sleep goals. The intervention encourages social support and self-efficacy through weekly sessions, group discussions, recipe preparation, and daily text messages promoting physical activity and healthy behaviors. A control group will receive diet and physical activity guidelines and later access to the nutrition education website. Participants will engage in baseline and post-intervention assessments including measures of feasibility, hemoglobin A1c, body mass index, and physical activity via accelerometer. Data on program satisfaction, technical issues, and adherence will be collected through surveys, interviews, and device monitoring. The study includes multiple phases involving focus groups, expert panel feedback, and field usability testing. Participation lasts 12 weeks with compensation provided and involves use of personal devices for program activities and monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identify as Hispanic
  • Have obesity defined as body mass index percentile at or above the 95th percentile
  • Aged between 12 and 16 years
  • Own a personal cellphone
Not Eligible

You will not qualify if you...

  • Taking medications or diagnosed with conditions that affect activity, sleep, or cognition (e.g., steroids, sleep apnea)
  • Recent hospitalization or injury preventing normal physical activity
  • Currently pregnant
  • Enrolled in an exercise program or using a personal activity monitoring device like Fitbit
  • Taking medications or diagnosed with conditions that influence activity, glucose metabolism, or cognition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to complete eligibility assessments including surveys and measurements

Orientation and Baseline Assessments

Duration - 1 day

Participants attend an orientation session where they receive study materials including a Fitbit, a workbook, and food items. Baseline assessments are conducted including physical measurements and questionnaires.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants in the intervention group receive access to 12 weekly pre-recorded nutrition and well-being sessions on a secure eLearning platform, use a Fitbit device, and interact with a chatbot for goal setting and planning physical activity and sleep behaviors. They also receive daily text messages to support behavior change. Participants in the control group receive diet and physical activity guidelines and access to the nutrition education website after 12 weeks.

Weekly online sessions with daily text messages; 1 initial orientation visit; 3 live online sessions for parents and youth

Post-intervention Assessments

Duration - 1 to 2 weeks

Participants complete follow-up assessments including physical measurements, laboratory tests, and questionnaires to evaluate changes after the intervention period.

1 visit (in-person) for post-intervention assessments

Trial Site Locations

Total: 1 location

1

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

Houston, Texas, United States, 77003

Actively Recruiting

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Research Team

E

Erica Soltero, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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