search
Back to results

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

Primary Purpose

Pre Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital diabetes prevention program (dDPP)
Adapted dDPP-EHR tool
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pre Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
December 29, 2020
Last Updated
April 5, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04773834
Brief Title
Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program
Official Title
A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Digital diabetes prevention program (dDPP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Adapted dDPP-EHR tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c) level (mmol/mol)
Description
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)
Time Frame
through completion of dDPP program (average 1 year)
Title
Body Weight (kilograms)
Description
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)
Time Frame
through completion of dDPP program (average 1 year)
Title
Body Mass Index (BMI) (kg/m2)
Description
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)
Time Frame
through completion of dDPP program (average 1 year)
Secondary Outcome Measure Information:
Title
dDPP platform user log-ins
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform lesson plans completed
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform coach messages sent
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform group social posts sent
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform step log (steps/day)
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform exercise log (min)
Description
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
Time Frame
through completion of dDPP program (average 1 year)
Title
dDPP platform meal log (food item and calories/day)
Description
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
Time Frame
through completion of dDPP program (average 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devin Mann, MD
Phone
212-263-8313
Email
hibrid.lab@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin Mann, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devin Mann, MD
Phone
212-263-8313
Email
hibrid.lab@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Devin Mann, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs