Clinical trial NCT06959901: PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents
Official title: Investigating the Efficacy of Mobile Health Monitoring and Self-care to Improve Obesity Outcomes in Hispanic Adolescence Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Diabetes Mellitus, Type 2
Diabetes Prevention
Keywords: mHealth
Digital health
teen health
lifestyle intervention
mobile phone app
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
First posted: 2025-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Recruitment
timeFrame: From enrollment to the end of the 30 day study.
measure: Feasibility of Technology
timeFrame: through study completion, an average of 30 days
measure: Usability
timeFrame: At the end of the 30 day study.
measure: Acceptability
timeFrame: At the end of the 30 day study.
measure: Acceptability
timeFrame: at the end of the 30 day study
Secondary outcomes:
measure: Health beliefs
timeFrame: From enrollment to the end of the 30 day study.
measure: Autonomous Motivation
timeFrame: From enrollment to the end of the 30 day study.
measure: Diet
timeFrame: From enrollment to the end of the 30 day study.
measure: Physical activity
timeFrame: From enrollment to the end of the 30 day study.
Other outcomes:
measure: Sleep
timeFrame: baseline, weekly through the 30 day intervention, and at post-intervention
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
References: