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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre Diabetes

Intervention / Treatment
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* Other: Digital diabetes prevention program (dDPP)
* Other: Adapted dDPP-EHR tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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)<br>* 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.<br>Other: Adapted dDPP-EHR tool<br>* 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.<br>|
| Other: Control group<br>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)<br>* 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.<br>|

What is the study measuring?
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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) |