NCT06959901 PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents
| NCT ID | NCT06959901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Obesity and Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-05-01 |
Trial Parameters
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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.
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
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