PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901 | Recruiting

• 1 other identifier: H-55556
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Diabetes Prevention; Obesity and Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Rate of Recruitment

  The rate of recruitment will be assessed to determine the feasibility of the research team's ability to recruit the target sample (N=30).

  From enrollment to the end of the 30 day study.

• Feasibility of Technology

  The number of technical issues reported by participants or the research team will be documented throughout the intervention.

  through study completion, an average of 30 days

• Usability

  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.

  At the end of the 30 day study.

• Acceptability

  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.

  At the end of the 30 day study.

• Acceptability

  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.

  at the end of the 30 day study

Secondary Outcomes (4)

• Health beliefs

  From enrollment to the end of the 30 day study.

• Autonomous Motivation

  From enrollment to the end of the 30 day study.

• Diet

  From enrollment to the end of the 30 day study.

• Physical activity

  From enrollment to the end of the 30 day study.

Other Outcomes (1)

• Sleep

  baseline, weekly through the 30 day intervention, and at post-intervention

Study Arms (1)

Mobile App

EXPERIMENTAL

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.

Behavioral: PATHS-UP Mobile Phone Application

Interventions

PATHS-UP Mobile Phone Application BEHAVIORAL

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.

Mobile App

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• U.S. National Science Foundation: collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77003, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pedro Garcia

CONTACT

(732)798-7092; Pedro.Garcia@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 7, 2025
• Study Start: April 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)