Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT04773834
Status:
COMPLETED
Last Update Posted:
2025-10-27
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-13', 'size': 191124, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-04T11:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) level (mmol/mol)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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)'}, {'measure': 'Body Weight (kilograms)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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)'}, {'measure': 'Body Mass Index (BMI) (kg/m2)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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)'}], 'secondaryOutcomes': [{'measure': 'dDPP platform user log-ins', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform lesson plans completed', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform coach messages sent', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform group social posts sent', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform step log (steps/day)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform exercise log (min)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}, {'measure': 'dDPP platform meal log (food item and calories/day)', 'timeFrame': 'through completion of dDPP program (average 1 year)', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre Diabetes']}, 'referencesModule': {'references': [{'pmid': '38875579', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older, BMI ≥ 25 kg/m2 (\\> 22 kg/m2 if self-identified as Asian)\n* Must be a NYU Langone patient\n* 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\n* Safe to engage in moderate physical exercise (as determined by their PCP)\n* Sufficient English to be able to complete the enrollment process\n* Has app-capable device with data to use the dDPP application and receive text messages\n\nExclusion Criteria:\n\n* Diagnosed with diabetes\n* Patients whose weight may vary considerably over the study's timeframe for reasons other than the intervention (e.g. cancer, pregnancy, ascites, severe CHF)\n* Patients with severe psychiatric disease or dementia\n* Active health condition that prevents them from engaging in moderate exercise"}, 'identificationModule': {'nctId': 'NCT04773834', 'briefTitle': 'Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program', 'orgStudyIdInfo': {'id': '20-01548'}, 'secondaryIdInfos': [{'id': '1R18DK118545-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R18DK118545-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', '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.', 'interventionNames': ['Other: Digital diabetes prevention program (dDPP)', 'Other: Adapted dDPP-EHR tool']}, {'type': 'OTHER', 'label': 'Control group', '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', 'interventionNames': ['Other: Digital diabetes prevention program (dDPP)']}], 'interventions': [{'name': 'Digital diabetes prevention program (dDPP)', 'type': 'OTHER', '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.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Adapted dDPP-EHR tool', 'type': 'OTHER', '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.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Devin Mann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}