Mobile App for Diabetes Prevention

(PATHS-UP Trial)

Overseen By Pedro Garcia

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Currently in health program, T2D, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help Hispanic teens improve health habits to prevent type 2 diabetes. The PATHS-UP Mobile Phone Application promotes better sleep, increased physical activity, and healthier eating through tools like self-monitoring and goal-setting. Participants will use the app for 30 days to track daily steps, weight, sleep, and food intake. Teens who may be suitable are those who self-identify as Hispanic, are 12-18 years old, have a BMI (body mass index) in the 85th-95th percentile, and own an iPhone. As an unphased trial, this study offers a unique opportunity for teens to contribute to innovative health solutions and enhance their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mobile app is safe for Hispanic adolescents?

Research has shown that mobile apps for managing diabetes are generally safe and well-received by users. These apps assist people in tracking health habits, such as exercise and diet, and offer feedback from healthcare professionals. Although specific safety data for the PATHS-UP Mobile Phone Application is not yet available, similar apps have been safely used for diabetes management. This study is in an early research phase, so limited safety data is available. However, the use of digital tools like this app in healthcare is increasing, and they are not known to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATHS-UP Mobile Phone Application because it offers a fresh approach to diabetes prevention by leveraging technology. Unlike traditional methods that might focus on diet plans or face-to-face counseling, this app empowers users through self-monitoring and health education right from their smartphones. It integrates an accelerometer for tracking daily steps, a remote Bluetooth scale for weight monitoring, and AI-powered food logging, making it a comprehensive tool for promoting healthy habits. This tech-driven, daily engagement strategy is what sets it apart from existing options, offering a more personalized and accessible way to encourage lifestyle changes.

What evidence suggests that this mobile app is effective for diabetes prevention in Hispanic adolescents?

Studies have shown that health apps can help people make healthier lifestyle changes and better manage their blood sugar levels. Research indicates that using digital tools to track steps and diet can lead to meaningful improvements. For people with diabetes, these apps have helped control HbA1c, an important measure of long-term blood sugar levels. Additionally, apps that combine tracking with coaching have successfully changed habits that can prevent type 2 diabetes. In this trial, participants will use the PATHS-UP mobile app, which may encourage healthier lifestyle choices among Hispanic teenagers at high risk for type 2 diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Hispanic adolescents aged 12-18 in the U.S. who are at high risk for type 2 diabetes due to factors like obesity and metabolic syndrome. The study aims to help them improve their health behaviors using a mobile app.

Inclusion Criteria

I own an iPhone.

Self-identify as Hispanic or Latino

BMI% in the 85th-95th range

Exclusion Criteria

Currently enrolled in a health program

I have a condition that stops me from being active.

I have been diagnosed with Type 2 Diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with a mobile health app and a Bluetooth-enabled scale for self-monitoring of weight, activity, sleep, and diet for 30 days

4 weeks

Remote engagement with app

Follow-up

Participants are monitored for continued engagement and effectiveness of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PATHS-UP Mobile Phone Application

Trial Overview The PATHS-UP Mobile Phone Application is being tested, which monitors and encourages healthy lifestyle habits such as physical activity, sleep, and diet over a period of 30 days.

How Is the Trial Designed?

Group I: Mobile App Experimental Treatment 1 Intervention

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 weekly surveys within the app, and caloric intake using a daily food log that is powered through artificial intelligence within the app.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

U.S. National Science Foundation

Collaborator

Trials

35

Recruited

9,000+

Published Research Related to This Trial

Supplemental text messaging (SMS4PreDM) was appealing to participants, particularly younger individuals and those from underserved populations, but it did not significantly enhance attendance or weight loss outcomes in the in-person National Diabetes Prevention Program (NDPP).

The study involved 488 participants over a year, comparing those who received in-person NDPP classes with and without the SMS4PreDM support, highlighting the need for further research to find effective strategies for improving NDPP outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. Ritchie, ND., Gutiérrez-Raghunath, S., Durfee, MJ., et al.[2021]

In a study of 171 adults with diabetes and prediabetes, high engagement with the Nutritionist Buddy Diabetes app (≥5 features) was linked to a significant weight loss of 10.6% over 6 months, highlighting the app's potential for effective weight management.

Participants who adhered to dietary guidelines, such as maintaining carbohydrate limits and logging meals, experienced notable reductions in HbA1c levels, with those logging meals for more than 5 days achieving a 1.2% reduction, indicating improved glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Mobile Health App Engagement and Weight Loss and Glycemic Control in Adults With Type 2 Diabetes and Prediabetes (D'LITE Study): Prospective Cohort Study. Lim, SL., Tay, MHJ., Ong, KW., et al.[2022]

Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.

Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. Ramchandani, N.[2020]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-3-2025-c6c58

Mobile App for Diabetes Prevention (PATHS-UP Trial) Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps ...

2. ctv.veeva.com ctv.veeva.com/study/paths-up-health-behavior-self-monitoring-mobile-app-for-adolescents

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

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1111/obr.70028

Based Interventions to Prevent Type 2 Diabetes Mellitus in ... ABSTRACT. Smartphone application (app)- based interventions to prevent Type 2 diabetes (T2D) are becoming increasingly available. A thor-.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5352856/

Efficacy of Mobile Apps to Support the Care of Patients With ... The use of apps by diabetic patients could help improve the control of HbA1c. In addition, the apps seem to strengthen the perception of self-care by ...

5. mhealth.jmir.org mhealth.jmir.org/2020/7/e17842

Mobile Delivery of the Diabetes Prevention Program in People ... Objective: This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control ...

6. diabetesjournals.org diabetesjournals.org/care/article/43/1/250/35864/Diabetes-Digital-App-Technology-Benefits

Diabetes Digital App Technology: Benefits, Challenges, and ... Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle ...

7. stacks.cdc.gov stacks.cdc.gov/view/cdc/164195/cdc_164195_DS1.pdf

Diabetes Management: Mobile Phone Applications Used ... Mobile phone applications (apps) for diabetes self-management accept patient data and provide patients with feedback from healthcare ...

8. mhealth.jmir.org mhealth.jmir.org/2018/6/e10115/

Considerations for the Development of Mobile Phone Apps to ... Background: There is increased research interest in the use of mobile phone apps to support diabetes management.