About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
self-identify as Hispanic or Latino
12-18 years
BMI% in the 85th-95th range,
Owns their own iphone
Disqualifiers
Currently enrolled in a health program
Diagnosed with T2D
Present with a disease or condition that would prevent one from engaging in activity
Trial design
Single group
Treatments tested in this trial
PATHS-UP Mobile Phone Application
BehavioralYouth 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Feasibility of Technology
The number of technical issues reported by participants or the research team will be documented throughout the intervention.
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.
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.
Secondary outcomes
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.
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.
Diet
Fruit \& vegetable intake, fat intake, and sugar sweetened beverage intake will be assessed using the NCI diet screener.
Physical activity
Physical activity will be assessed using the accelerometer embedded within the participants smartphone to assess days/steps.
Other outcomes
Sleep
Self-reported survey on average minutes of sleep per night and self-rated sleep quality measured on a Likert scale of 1-5, with 5 being great sleep quality.
Sponsors and contacts
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Baylor College of Medicine
Lead sponsor
U.S. National Science Foundation
Collaborator