A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 551
- Locations
- 1
- Primary Endpoint
- Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Digital diabetes prevention program (dDPP) (Other)
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.
Intervention: Adapted dDPP-EHR tool (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
Intervention: Digital diabetes prevention program (dDPP) (Other)
Outcomes
Primary Outcomes
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
Time Frame: Baseline, Month 6
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.
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
Time Frame: Baseline, Month 12
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.
Change in Body Weight (Lbs)
Time Frame: Baseline, Month 6
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.
Change in Body Weight (Lbs)
Time Frame: Baseline, Month 12
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.
Change in Body Mass Index (BMI) (Lbs/in^2)
Time Frame: Baseline, Month 6
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.
Change in Body Mass Index (BMI) (Lbs/in^2)
Time Frame: Baseline, Month 12
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.
Secondary Outcomes
- Engagement With the dDPP Platform(Month 6)
- Engagement With the dDPP Platform(Month 12)