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: Recruiting
• 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 (Estimated): 490
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sumaiya Tasneem; Phone Number: 646-501-2904; Email: sumaiya.tasneem@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Devin Mann, MD; Phone Number: 212-263-8313; Email: hibrid.lab@nyulangone.org
      • Principal Investigator: Devin Mann, MD

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
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)	through completion of dDPP program (average 1 year)
Body Weight (kilograms)	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)	through completion of dDPP program (average 1 year)
Body Mass Index (BMI) (kg/m2)	BMI will be calculated using height (m) from electronic health records and weight (kg) from remote Bluetooth-connected weight scales. Data will be collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion)	through completion of dDPP program (average 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dDPP platform user log-ins	Perceptions of patient engagement will be collected via surveys from patients measured using data on number of dDPP logins, as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform lesson plans completed	Perceptions of patient engagement will be collected via surveys from patients using the number of completion of weekly lesson plans, as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform coach messages sent	Perceptions of patient engagement will be collected via surveys from patients using data on number of messages to coaches as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform group social posts sent	Perceptions of patient engagement will be collected via surveys from patients using data on number of messages to online social groups, as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform step log (steps/day)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed platform step logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform exercise log (min)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed platform exercise logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)
dDPP platform meal log (food item and calories/day)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed meal logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): September 1, 2024

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 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• 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