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

NCT04773834 | Completed Results DMC

• 2 other identifiers: 20-015481R18DK118545-01A1
• Study Type: interventional
• Target: 551
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (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 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. Changes were assessed relative to baseline.

  Baseline, Month 6

• 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

Secondary Outcomes (2)

• Engagement With the dDPP Platform

  Month 6

• Engagement With the dDPP Platform

  Month 12

Study Arms (2)

Experimental group

EXPERIMENTAL

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); Other: Adapted dDPP-EHR tool

Control group

OTHER

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)

Interventions

Digital diabetes prevention program (dDPP) OTHER

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.

Control group; Experimental group

Adapted dDPP-EHR tool OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 38875579 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Devin Mann, MD
• Organization: NYU Langone Health

devin.mann@nyulangone.org

2122639026

Study Officials

• Devin Mann, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: February 26, 2021
• Study Start: February 1, 2021
• Primary Completion: January 15, 2025
• Study Completion: June 1, 2025
• Last Updated: March 3, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)