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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK118545-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
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| Control group | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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). Changes were assessed relative to baseline. | Baseline, Month 6 |
| Change in 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). Changes were assessed relative to baseline. | Baseline, Month 12 |
| Change in Body Weight (Lbs) | 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. | Baseline, Month 6 |
| Change in Body Weight (Lbs) | 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. | Baseline, Month 12 |
| Change in Body Mass Index (BMI) (Lbs/in^2) | 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. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement With the dDPP Platform | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devin Mann, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38875579 | Derived | Rodriguez DV, Chen J, Viswanadham RVN, Lawrence K, Mann D. Leveraging Machine Learning to Develop Digital Engagement Phenotypes of Users in a Digital Diabetes Prevention Program: Evaluation Study. JMIR AI. 2024 Mar 1;3:e47122. doi: 10.2196/47122. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 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). Changes were assessed relative to baseline. | The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations. | Posted | Mean | Standard Deviation | mmol/mol | Baseline, Month 6 |
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SAEs and AEs were assessed until the end of treatment, approximately 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devin Mann, MD | NYU Langone Health | 2122639026 | devin.mann@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2024 | Jan 14, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Sep 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| Change in Body Mass Index (BMI) (Lbs/in^2) | 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. | Baseline, Month 12 |
| Month 6 |
| Engagement With the dDPP Platform | 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 | Month 12 |
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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 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. |
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| Primary | Change in 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). Changes were assessed relative to baseline. | Posted | Mean | Standard Deviation | mmol/mol | Baseline, Month 12 |
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|
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| Primary | Change in Body Weight (Lbs) | 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. | The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations. | Posted | Mean | Standard Deviation | lbs | Baseline, Month 6 |
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| Primary | Change in Body Weight (Lbs) | 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. | Posted | Mean | Standard Deviation | lbs | Baseline, Month 12 |
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|
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| Primary | Change in Body Mass Index (BMI) (Lbs/in^2) | 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. | Only 163 participants in the experimental group and 94 participants in the control group were analyzed. The others were missing weight data at either 6 or 12 months and were excluded. This analysis was done separately from the other outcomes, which used multiple imputation to help fill in the missing data. | Posted | Mean | Standard Deviation | lbs/in^2 | Baseline, Month 6 |
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| Primary | Change in Body Mass Index (BMI) (Lbs/in^2) | 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. | Only 163 participants in the experimental group and 94 participants in the control group were analyzed. The others were missing weight data at either 6 or 12 months and were excluded. This analysis was done separately from the other outcomes, which used multiple imputation to help fill in the missing data. | Posted | Mean | Standard Deviation | lbs/in^2 | Baseline, Month 12 |
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| Secondary | Engagement With the dDPP Platform | 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 | The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Engagement With the dDPP Platform | 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 | The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 0 |
| 284 |
| 0 |
| 284 |
| 0 |
| 284 |
| EG001 | 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 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. | 0 | 151 | 0 | 151 | 0 | 151 |
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