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Completed

NCT Number: NCT04773834

Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the 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.

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Key information

Conditions

Pre Diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Engagement With the dDPP Platform

    Time frame: Month 6

    Engagement was defined as completion of the following Noom activities: submission of at least one weigh-in; reading one article per week; participation in socialization through either one group post per week or one message to a Noom coach; and meeting physical activity goals by achieving either 150 minutes of activity or the step target assigned by Noom. Outcome measure is assessed as as score on a scale, where 0=Fail, and 1=pass

  2. Engagement With the dDPP Platform

    Time frame: Month 12

    Engagement was defined as completion of the following Noom activities: submission of at least one weigh-in; reading one article per week; participation in socialization through either one group post per week or one message to a Noom coach; and meeting physical activity goals by achieving either 150 minutes of activity or the step target assigned by Noom. Outcome measure is assessed as as score on a scale, where 0=Fail, and 1=pass

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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