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

Trial Summary

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 data supports the effectiveness of the PATHS-UP Mobile Phone Application treatment for diabetes prevention?

Research shows that digital diabetes prevention programs, like the PATHS-UP app, can help people make lifestyle changes to prevent type 2 diabetes. Studies have found that these programs, especially when combined with support like text messages, can lead to modest weight loss and better blood sugar control, which are important for preventing diabetes. ^{1 2 3 4 5}

Is the PATHS-UP Mobile Phone Application safe for humans?

The research does not provide specific safety data for the PATHS-UP Mobile Phone Application, but similar mobile and text-based diabetes prevention programs have been used without reported safety issues. ^{1 4 6 7 8}

How is the PATHS-UP Mobile Phone Application treatment for diabetes prevention unique?

The PATHS-UP Mobile Phone Application is unique because it combines a mobile app with a pedometer to deliver weight-loss interventions, making it a convenient and cost-effective way to prevent type 2 diabetes. Unlike traditional methods, it offers real-time, individualized support through virtual coaching, which can enhance engagement and provide personalized guidance anytime and anywhere. ^{6 7 9 10 11}

What is the purpose of 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Influences on Patient Uptake of and Engagement With the National Health Service Digital Diabetes Prevention Programme: Qualitative Interview Study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial. [2020]

3. Canada 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. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016-2018. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Novel Diabetes Prevention Intervention Using a Mobile App: A Randomized Controlled Trial With Overweight Adults at Risk. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Weight loss efficacy of a novel mobile Diabetes Prevention Program delivery platform with human coaching. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Short Message Service Text Message Support for Weight Loss in Patients With Prediabetes: Pragmatic Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Identifying critical features of type two diabetes prevention interventions: A Delphi study with key stakeholders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of an Automated Text Message-Based Diabetes Prevention Program for Adults With Pre-diabetes. [2023]