Digital Diabetes Prevention Program with Automated Messaging for Prediabetes

Overseen By Devin Mann, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Diabetes, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether automated messages from doctors can help people stay engaged in a digital program designed to prevent diabetes. Participants use an app to follow the digital diabetes prevention program (dDPP), and the messages aim to boost involvement based on their activity in the app. The trial seeks to prevent diabetes and improve health outcomes. It is recruiting NYU Langone patients who have prediabetes or are at risk, have a BMI of 25 or higher (23 or higher for Asians), and can safely perform moderate exercise. Participants need a smartphone with internet access to receive messages and use the app. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes prevention strategies.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this digital diabetes prevention program is safe?

Research has shown that digital diabetes prevention programs, like the one in this study, have been well-received by participants. Studies indicate that these programs help people track important health information, such as weight and activity levels, which they can share with healthcare providers.

Previous findings suggest that digital tools for diabetes prevention can ease participation by removing obstacles. Automated messages, a part of this digital approach, encourage participation without adding stress.

No major safety issues have been reported with these digital methods. Participants generally manage the program well, as it mainly involves receiving messages and tracking health data through an app. This makes it a low-risk option for those interested in joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new digital approach to preventing diabetes using the Noom app, which is different from traditional in-person programs like lifestyle coaching or medication. Unlike conventional methods that require face-to-face meetings or prescription drugs, this program leverages automated text messaging to enhance engagement and deliver real-time support based on user interaction. This digital method aims to make diabetes prevention more accessible and adaptable to individual needs, potentially increasing user adherence and effectiveness in managing prediabetes.

What evidence suggests that this digital diabetes prevention program is effective for prediabetes?

Research has shown that digital diabetes prevention programs (dDPP) can effectively help people with prediabetes improve their health. In this trial, participants in the experimental group will use a modified dDPP through the Noom app, receiving personalized text messages based on their engagement levels. Studies have found that participants using a modified dDPP have successfully lost weight, which is important for preventing diabetes. These programs have been especially helpful for low-income patients, demonstrating their ability to reach people from various backgrounds. The digital format simplifies tracking key health information like weight and activity levels. By using a digital platform, patients can stay more engaged and motivated, leading to better health outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Devin Mann, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for NYU Langone patients over 18 with a BMI ≥ 25 (or > 22 if Asian), who can safely exercise, speak English well enough to enroll, have an app-capable device, and are diagnosed with prediabetes or at risk of diabetes. It excludes those already diagnosed with diabetes, unable to exercise moderately due to health conditions, significant weight fluctuation issues unrelated to the intervention, or severe psychiatric disease/dementia.

Inclusion Criteria

Sufficient English to be able to complete the enrollment process

Has app-capable device with data to use the dDPP application and receive text messages

Your doctor says it's okay for you to do moderate physical exercise.

Exclusion Criteria

You have a serious mental illness or dementia.

My weight changes are not due to the study's treatment but may be because of other health conditions.

You have a health condition that stops you from doing moderate exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline

Participants are enrolled virtually into the digital diabetes prevention program through the Noom app

0 month (at enrollment)

Virtual enrollment

Intervention

Participants receive automated targeted messaging based on their engagement levels in the digital diabetes prevention program

12 months

Continuous virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted dDPP-EHR tool
• Digital diabetes prevention program (dDPP)

Trial Overview The study tests whether automated messages from doctors can increase patient involvement in a digital diabetes prevention program. The messages vary based on how much patients use the dDPP app and aim to prevent diabetes onset and improve outcomes by encouraging more engagement through texts and MyChart messages.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 2 Interventions

Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.

Group II: Control group Experimental Treatment 1 Intervention

Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The digital Diabetes Prevention Program (d-DPP) significantly improved HbA1c levels and body weight among participants with prediabetes, showing a reduction in HbA1c by 0.08% and a weight loss of 5.5% compared to standard care.

Participants in the d-DPP were more likely to achieve clinically significant weight loss (43% vs 21%) and transition from prediabetes to normal HbA1c levels (58% vs 48%), indicating its effectiveness in preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Digital Diabetes Prevention Program: An RCT. Katula, JA., Dressler, EV., Kittel, CA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT04049500

Adapt and Incorporate dDPP Into Clinical Workflows | ... This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data ...

2. reporter.nih.gov reporter.nih.gov/search/tlwZYqN_U0yW4XGtF2RXHA/project-details/9815834

RePORT RePORTER - National Institutes of Health (NIH) | This tool pushes meaningful visualizations of key dDPP data elements (e.g. weight, activity, lesson completion) directly into the complex EHR workflows of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6896833/

Evaluation of a Digital Diabetes Prevention Program ... The modified DPP successfully engaged participants and resulted in weight loss. Low-income patients with prediabetes benefitted from a digitally ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865418300164

Evaluation of a digital diabetes prevention program ... This evaluation collects both quantitative and qualitative data on the experience of patients utilizing the digital DPP to evaluate clinical outcomes and to ...

5. researchprotocols.org researchprotocols.org/2025/1/e64405

Virtual Diabetes Prevention Program Tailored to Increase ... This study highlights the effort required to reach and engage Black and Latino men for virtually delivered diabetes prevention programs.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04773834

Study Details | NCT04773834 | Evaluation of an Automated ... This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04049500

Adapt and Incorporate dDPP Into Clinical Workflows | ... This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8714274/

Development of a computer-aided text message platform ... The DPP curriculum has been successfully adapted to a variety of digital DPP (dDPP), which offer an alternative to delivering in-person diabetes ...

9. cdc.gov cdc.gov/pcd/issues/2019/19_0156.htm

Evaluation of a Digital Diabetes Prevention Program ... Our study examined a digitally delivered DPP that removed some barriers to access and increased participation for low-income patients.