Recruiting

Digital Health Platform

Sponsor:

Baylor College of Medicine

Code:

NCT06959901

Conditions

Obesity and Diabetes Mellitus, Type 2

Diabetes Prevention

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

PATHS-UP Mobile Phone Application

Study Details

Brief summary:

Hispanic adolescents in the U.S. are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population. Disparities in T2D are driven in part by independent, modifiable risk factors including low levels of physical activity, sleep, and poor diet. Lifestyle interventions are the cornerstone for maintaining glucose control and managing T2D. However, few studies have developed and tested lifestyle interventions for Hispanic youth with T2D. Digital health interventions that promote healthy lifestyle behaviors like physical activity, sleep, and diet, have demonstrated effectiveness among adults. Studies that use health-based smartphone applications have demonstrated preliminary efficacy for improving health-related lifestyle behaviors as these digital tools leverage behavior change techniques (e.g. self-monitoring, goal-setting, feedback) that have proven effective. Use of digital technology allows for the continuous delivery of intervention content into the home environment extending the reach of clinical care while engaging youth in a format that is age-appropriate given that today's youth are digital frontrunners. Unfortunately, while the use of digital health interventions have increased, few studies have focused on adolescents with overweight and obesity who are at high risk for T2D. The purpose of this study is to 1) develop a mobile health platform for remote and continuous monitoring of activity, sleep, and nutrition and 2) conduct a pilot study (30 days) to evaluate the efficacy of a novel digital health platform in improving obesity-related health outcomes outcomes in Hispanic adolescents (12-18 years; N=30) population.

Conditions

Obesity and Diabetes Mellitus, Type 2

Diabetes Prevention

Study ID

NCT06959901

Start date

Apr 30, 2025

Status verified date

Jul, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • self-identify as Hispanic or Latino
  • 12-18 years
  • BMI% in the 85th-95th range,
  • Owns their own iphone

Exclusion Criteria:

  • Currently enrolled in a health program
  • Diagnosed with T2D
  • Present with a disease or condition that would prevent one from engaging in activity

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mobile App

Youth in the intervention will be given access to a health-based mobile phone application and a remote bluetooth scale. The app is focused on promoting health education and self-monitoring. For 30 days youth will be asked to engage with content focused on promoting healthy sleep, physical activity, and dietary habits every day. Youth will also be asked to self-monitor health behaviors using the app as it pulls in data on daily steps from the accelerometer embedded within the smartphone, information on weight from daily weigh-ins using the remote scale, sleep via weekly surveys within the app, and caloric intake using a daily food log that is powered through artificial intelligence within the app.

Interventions

PATHS-UP Mobile Phone Application

Youth in the intervention will be given access to a health-based mobile phone application and a remote bluetooth scale. The app is focused on promoting health education and self-monitoring. For 30 days youth will be asked to engage with content focused on promoting healthy sleep, physical activity, and dietary habits every day. Youth will also be asked to self-monitor health behaviors using the app as it pulls in data on daily steps from the accelerometer embedded within the smartphone, information on weight from daily weigh-ins using the remote scale, sleep via a weekly survey within the app, and caloric intake using a daily food log that is powered through artificial intelligence within the app.

Primary outcome measure

  • Rate of Recruitment [ Time Frame: From enrollment to the end of the 30 day study. ]
  • Feasibility of Technology [ Time Frame: through study completion, an average of 30 days ]
  • Usability [ Time Frame: At the end of the 30 day study. ]
  • Acceptability [ Time Frame: At the end of the 30 day study. ]
  • Acceptability [ Time Frame: at the end of the 30 day study ]

Central Contacts and Locations

Central contacts

Locations

Children's Nutrition Research Center

Recruiting

Houston, Texas, United States, 77003

Contacts

Erica Soltero Principal Investigator

402-910-0832soltero@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • mHealth
  • Digital health
  • teen health
  • lifestyle intervention
  • mobile phone app

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-07-07.