NCT06959901 · Baylor College of Medicine
PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents
(PATHS-UP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Rate of Recruitment
Time frame: From enrollment to the end of the 30 day study.
The rate of recruitment will be assessed to determine the feasibility of the research team's ability to recruit the target sample (N=30).
Feasibility of Technology
Time frame: through study completion, an average of 30 days
The number of technical issues reported by participants or the research team will be documented throughout the intervention.
Usability
Time frame: At the end of the 30 day study.
The system usability scale will be used to assess feasibility. Scores using this tool range from 0 to 100, with a higher score will indicating higher usability.
Acceptability
Time frame: At the end of the 30 day study.
Acceptability will be assessed using an exit survey. The research team will use a Likert scale to assess the acceptability of various components of the study including the mobile phone app interface, content, etc. A higher score will indicate greater satisfaction.
Acceptability
Time frame: at the end of the 30 day study
To assess acceptability, the research team will also use an exit interview to gather more in-depth perspectives on the mobile phone application, the content, and the participant's experience using the app to improve health behaviors. These interviews will be analyzed using thematic content analysis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Collaborators
U.S. National Science Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations