Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program

A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program

This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.

Study Overview

• Status: Completed
• Conditions: Pre Diabetes
• Intervention / Treatment: Other: Digital diabetes prevention program (dDPP); Other: Adapted dDPP-EHR tool

Detailed Description

Using a mixed-methods design, this study will be completed in three phases. For Phase 3, we aim to conduct a randomized control trial with 400 patients with pre-diabetic, all of whom will be using the dDPP application. Half of enrolled patients will be randomized to the intervention group and receive automated targeted messaging.

• Study Type: Interventional
• Enrollment (Actual): 551
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older, BMI ≥ 25 kg/m2 (> 22 kg/m2 if self-identified as Asian)
• Must be a NYU Langone patient
• A diagnosis of prediabetes (either diagnosis of prediabetes or an HbA1C level of 5.7%-6.4% in past 12 months) or diabetes risk factors (BMI ≥ 25 kg/m2 or > 22 kg/m2 if self-identified as Asian
• Safe to engage in moderate physical exercise (as determined by their PCP)
• 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

Exclusion Criteria:

• Diagnosed with diabetes
• Patients whose weight may vary considerably over the study's timeframe for reasons other than the intervention (e.g. cancer, pregnancy, ascites, severe CHF)
• Patients with severe psychiatric disease or dementia
• Active health condition that prevents them from engaging in moderate exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Other: Digital diabetes prevention program (dDPP); The digital diabetes prevention program is through the Noom app, and the three devices (Fitbit physical activity tracker, Fitbit weight scale, and self-check hemoglobin a1c kit). This is a one year diabetes prevention program where participants will be expected to participate in 5 to 7 interviews over a 18 month period.; Other: Adapted dDPP-EHR tool; This is a product of Phase 1 and 2 of this study where participants will receive detailed text messaging regarding their engagement levels in Noom app.
Other: Control group; 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	Other: Digital diabetes prevention program (dDPP); The digital diabetes prevention program is through the Noom app, and the three devices (Fitbit physical activity tracker, Fitbit weight scale, and self-check hemoglobin a1c kit). This is a one year diabetes prevention program where participants will be expected to participate in 5 to 7 interviews over a 18 month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)	Repeated measurements of participant HbA1c will be taken via HbA1C home test kit and electronic health records. Data will be collected at discrete time points: 0 month (at enrollment), 6 months, 12 months (study completion). Changes were assessed relative to baseline.	Baseline, Month 6
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)	Repeated measurements of participant HbA1c will be taken via HbA1C home test kit and electronic health records. Data will be collected at discrete time points: 0 month (at enrollment), 6 months, 12 months (study completion). Changes were assessed relative to baseline.	Baseline, Month 12
Change in Body Weight (Lbs)	Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Data will be collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.	Baseline, Month 12
Change in Body Mass Index (BMI) (Lbs/in^2)	BMI was calculated using height (in) from electronic health records and weight (lbs) from remote Bluetooth-connected weight scales. Data was collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.	Baseline, Month 6
Change in Body Mass Index (BMI) (Lbs/in^2)	BMI was calculated using height (in) from electronic health records and weight (lbs) from remote Bluetooth-connected weight scales. Data was collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.	Baseline, Month 12
Change in Body Weight (Lbs)	Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Changes were assessed relative to baseline.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement With the dDPP Platform	Engagement was defined as completion of the following Noom activities: submission of at least one weigh-in; reading one article per week; participation in socialization through either one group post per week or one message to a Noom coach; and meeting physical activity goals by achieving either 150 minutes of activity or the step target assigned by Noom. Outcome measure is assessed as as score on a scale, where 0=Fail, and 1=pass	Month 6
Engagement With the dDPP Platform	Engagement was defined as completion of the following Noom activities: submission of at least one weigh-in; reading one article per week; participation in socialization through either one group post per week or one message to a Noom coach; and meeting physical activity goals by achieving either 150 minutes of activity or the step target assigned by Noom. Outcome measure is assessed as as score on a scale, where 0=Fail, and 1=pass	Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Devin Mann, MD, NYU Langone Health

Publications and helpful links

General Publications

• Rodriguez DV, Chen J, Viswanadham RVN, Lawrence K, Mann D. Leveraging Machine Learning to Develop Digital Engagement Phenotypes of Users in a Digital Diabetes Prevention Program: Evaluation Study. JMIR AI. 2024 Mar 1;3:e47122. doi: 10.2196/47122.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance
• Other Study ID Numbers: 20-01548; 1R18DK118545-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to hibrid.lab@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No