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Obesity and Diabetes Mellitus, Type 2PATHS-UPNCT06959901

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

A study testing PATHS-UP Mobile Phone Application in people with Obesity and Diabetes Mellitus, Type 2 and Diabetes Prevention, run by Baylor College of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
What is being tested?
PATHS-UP Mobile Phone Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Apr 2025to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Children's Nutrition Research Center

    Houston, Texas, 77003

    Erica Soltero Principal Investigator, 402-910-0832, soltero@bcm.edu

    Recruiting

Other trials in United States

About this study

Official title: Investigating the Efficacy of Mobile Health Monitoring and Self-care to Improve Obesity Outcomes in Hispanic Adolescence Populations

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.

Read the detailed description

To test the feasibility and acceptability of a health-based mobile phone application the research team will recruit a sample of Hispanic adolescents (12-18 years; N=30) with overweight and obesity. Once informed consent and youth assent have been collected, youth will be enrolled into the intervention. Investigators will leverage an existing digital monitoring platform consisting of a Bluetooth-enabled weight scale and the mobile health app developed through Apple iOS which provides advanced activity and sleep tracking features, visualizations and trends, and self-reporting functionality. This interface integrates data from the accelerometer embedded within the participant's own smartphone. This accelerometer integrates data including steps and physical activity minutes into the app. Users do not need to sign any agreements with apple or any end user licenses. All data obtained through the app is transmitted to the digital monitoring platform before it is integrated into a REDCap database. Youth will be provided with a remote bluetooth enabled scale which will transmit data into the digital platform. The app provides youth with an AI enabled component to log their daily diet as well as a weekly survey to assess sleep.

A longitudinal, pre-post design will be used to test the 30-day intervention. The investigators will leverage existing collaborations with the Department of Endocrinology at Texas Children's Hospital and an existing network of physicians within the Texas Children's Health Plan and Harris Health Pediatric Clinics. Study flyers will be placed in waiting and exam rooms and physicians in participating clinics will be encouraged to refer eligible patients to the study. The research team will also attend community-wide events such as back to school fairs and food drives at partnering community-based organizations (e.g. Baker Ripley) where the research team will pass out flyers and share study information for attendees. The research team also have a sign up sheet where interested participants can leave their contact information if they would like to receive more information about the study. Lastly, the Children's Nutrition Research Center maintains a volunteer participant registry, which includes youth who have expressed interest in participating in future research projects. Participants within the registry who are eligible will be invited via a phone call to participate in this study. These participants have consented to be contacted for future projects. The research team will also send a text message to interested participants who have consented through the registry or have volunteered their contact information at community events. This text will share a brief information video in English or Spanish to generate interest in the study.

If participants agree to join the study, they will receive information and parental consent and child assent will be obtained prior to any study procedures. Once they join the study, participants will receive an IndieHealth Bluetooth-enabled weight scale and a customized mobile health app and will be asked to conduct daily self-measurement of weight, complete daily educational tasks, and log meals for 30 days. Participants will receive instructions explaining how the accelerometer embedded within their phone will be used to integrate step and sleep data into the health app. Daily motivational and persuasive messages will be sent to participants to assist them in increasing their activity, sleep, and dietary habits towards the recommended national guidelines. Youth will also receive prompts to self-monitor their health behaviors. The messages and content that youth will receive are theory-informed and were previously developed with youth and research experts to ensure that they are theoretically adherent, culturally, and age appropriate.

Feasibility will be examined using research notes and careful documentation of recruitment, data collection, technical issues, engagement, and satisfaction. The acceptability, utility, and engagement with the mobile health platform will be measured using a study-specific, process evaluation questionnaire. This will provide information on the availability of high-risk youth in community clinics willing to participate in a digital health program and the ability to recruit, retain, and engage this population. Careful documentation of technical issues will speak to the feasibility of developing and implementing this type of technology for health promotion and disease prevention purposes.

In addition to feasibility, several outcomes will be assessed including weight, average steps/day, average minutes of sleep/night, and dietary intake as collected through the mobile health app. A remote scale will be used to measure weight, and a self-reported fat, fruit, and vegetable screener (National Cancer Institute) to assess dietary intake. Baseline and post-intervention assessments will be conducted and will consist of a demographic survey to be completed by parents. Motivation for exercise will be measured using a 9-item survey, which has shown acceptable validity and reliability among youth. Following the intervention, youth will be asked to complete a system usability scale to understand the acceptability and feasibility of the app and program from the perspective of the participant.

To further assess acceptability, an exit interview will be conducted with a subsample of participants (N=15) to evaluate the experience and identify barriers and opportunities for further redesigns. This information will also provide guidance on the acceptability of this strategy among this age and ethnic subgroup. In-depth interviews be conducted via a dedicated study line. They will be audio-recorded, transcribed, coded by two trained, independent coders, and qualitatively analyzed using NVivo version 9. Thematic content analysis will be used to identify emergent themes to adapt existing text messages. App related data (weight, steps, sleep, diet) will be monitored including engagement metrics (e.g. participant logins, app usage) and any data transmitted through the app including the food diary, step count, and weight data. All data will be de-identified and will only include a unique participant identifier in the form of a numerical number.

All surveys and assessments will be conducted remotely using secure links generated through REDCap.

Being tested
PATHS-UP Mobile Phone Application
Keywords
mHealth, Digital health, teen health, lifestyle intervention, mobile phone app
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PATHS-UP Mobile Phone ApplicationBehavioural

    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.

Study groups in NCT06959901
Study groupRoleWhat they receive
Mobile AppExperimentalYouth 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.
Receives: Behavioral: PATHS-UP Mobile Phone Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From enrollment to the end of the 30 day study.

  2. Feasibility of Technology

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

    Measured: through study completion, an average of 30 days

  3. 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.

    Measured: At the end of the 30 day study.

  4. 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.

    Measured: At the end of the 30 day study.

  5. 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.

    Measured: at the end of the 30 day study

Secondary outcomes (4)
  1. Health beliefs

    The health beliefs model survey will be used to assess how youth perceive their susceptibility to a health condition and the benefits of taking action, and the barriers to taking action.

    Measured: From enrollment to the end of the 30 day study.

  2. Autonomous Motivation

    A survey will be used to assess the degree to which the desire to change health behaviors is autonomously motivated. A higher score will indicate higher reported autonomous motivation.

    Measured: From enrollment to the end of the 30 day study.

  3. Diet

    Fruit \& vegetable intake, fat intake, and sugar sweetened beverage intake will be assessed using the NCI diet screener.

    Measured: From enrollment to the end of the 30 day study.

  4. Physical activity

    Physical activity will be assessed using the accelerometer embedded within the participants smartphone to assess days/steps.

    Measured: From enrollment to the end of the 30 day study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start30 Apr 2025
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959901
Sponsor's protocol ID
H-55556
Acronym
PATHS-UP
Status last verified
Jul 2026
First submitted
14 Apr 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will share anonymous data through our institutional data registry.

Questions about this trial

What is this clinical trial studying?

A study testing PATHS-UP Mobile Phone Application in people with Obesity and Diabetes Mellitus, Type 2 and Diabetes Prevention, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pedro Garcia ((732)798-7092, Pedro.Garcia@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Recruitment (time frame: From enrollment to the end of the 30 day study.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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