Clinical trial
PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents
Recruiting now · Not applicable · 1 countries · Registry ID NCT06959901
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. 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.
Basic eligibility
Full registry criteria
Treatments and study arms
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 outcomes
The rate of recruitment will be assessed to determine the feasibility of the research team's ability to recruit the target sample (N=30).
The number of technical issues reported by participants or the research team will be documented throughout the intervention.
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 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.
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.
Study locations
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