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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK125780-01 | 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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The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.
After being informed about the study and potential risk, all participants giving written informed consent will undergo screening to determine eligibility for study entry. At baseline visit (month 0). Participants who meet the eligibility requirements will be randomly assigned in 1:1 ratio to human coach-based diabetes prevention program or digital diabetes prevention program. An equal number of participants will be randomly assigned to both groups (like flipping a coin).
If participants are randomly assigned to receive the human coach-based diabetes prevention program, the participants will be referred to a local Diabetes Prevention Program close to the participants' area. The Diabetes Prevention Program consists of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.
If participants are randomly assigned to receive the digital Diabetes Prevention Program, the participants will receive the Sweetch Digital Health Kit (Sweetch Health, Ltd.) in the mail within approximately 8-12 days of the participants' first study visit. The Sweetch digital health kit consists of a smartphone app and a digital body weight scale that is connected via Bluetooth to the app. The phone app also consists of brief Centers for Disease Control and Prevention (CDC) lessons on type 2 diabetes prevention, which participants will be encouraged to complete.
There will be a total of 3 study visits (baseline, 6 months, and 12 months), each visit includes fingerstick hemoglobin A1C measurement, weight measurement, and completion of several questionnaires. Height will be measured at the first visit. Throughout the 12-month study, participants will be asked to wear a device on the participants' wrist to measure physical activity for 7 consecutive days following the first visit and once every month thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully-Automated Digital Diabetes Prevention Program | Experimental | Participants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app. |
|
| Human Coach-Based Diabetes Prevention Program | Active Comparator | Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Diabetes Prevention Program (dDPP) | Behavioral | The Sweetch app is a hyper-personalized mobile digital coach that provides users with tailored recommendations to promote healthy lifestyle behaviors (150 minutes per week of physical activity, weight reduction, and healthy eating habits) to reduce the risk of type 2 diabetes. The Sweetch app uses self-tracking and multiple evidence-based persuasive eCoaching strategies. The Sweetch artificial intelligence algorithm delivers just-in-time support and/or adapt recommendations based on the user's response. For example, push notifications will be sent when the algorithm detects that the user is potentially available and able to act upon the recommendation, based on various parameters including location, previous response, calendar availability, and weather, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) | The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Weight Change | Absolute weight change (kilograms) from baseline to 12 months | At 12 months |
| Cost-effectiveness as Assessed by the Markov Model | The investigators will compare the cost-effectiveness of the two interventions based on lifetime horizon by constructing a Markov model with model parameters populated from the trial results as well as other published literature. The model will estimate the incremental cost-effectiveness ratio between the two interventions. |
Not provided
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Laboratory evidence of prediabetes, defined as any of the following lab results, in the past year:
Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians).
Proficiency in reading English.
Smartphone user (Android Operating System (OS) 9.0 or iOS 13.3 or newer).
Plans to reside in recruitment area for the next 12 months (participant's zip code of residence is within ~45 miles of the study recruitment site.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestoras Mathioudakis, MD MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Reading Hospital - Tower Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144242 | Derived | Mathioudakis N, Lalani B, Abusamaan MS, Alderfer M, Alver D, Dobs A, Kane B, McGready J, Riekert K, Ringham B, Shehadeh A, Vandi F, Wanigatunga AA, Zade D, Maruthur NM; AI-DPP Study Group. An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial. JAMA. 2025 Dec 16;334(23):2079-2089. doi: 10.1001/jama.2025.19563. | |
| 38755706 | Derived | Abusamaan MS, Ballreich J, Dobs A, Kane B, Maruthur N, McGready J, Riekert K, Wanigatunga AA, Alderfer M, Alver D, Lalani B, Ringham B, Vandi F, Zade D, Mathioudakis NN. Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial. Trials. 2024 May 16;25(1):325. doi: 10.1186/s13063-024-08177-8. |
| Label | URL |
|---|---|
| Study Website | View source |
Not provided
The Data Coordinating Center (Johns Hopkins University) will prepare a de-identified database that is consistent with HIPAA requirements. The de-identified database will include all study research data and will be stored in a repository at Johns Hopkins University (archive.data.jhu.edu) at a time that will coincide with the online publication of the study primary endpoint paper. The repository will contain documentation designed to facilitate use of the database. The documentation prepared for the repository will include a list and timetable for secondary and exploratory papers planned by the study investigators. Access to the database will be restricted to qualified users. Qualified users will include those investigators who submit valid pre-specified hypotheses and certify that they will not use the data for commercial purposes.
The study protocol will be submitted for publication within 1 year of the start of enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Intelligence-Based Diabetes Prevention Program (AI-DPP) | Participants in the AI-DPP group were referred to Sweetch Health, Ltd, and received a digital health kit from within 8-12 days post-randomization, which included a Bluetooth scale and Sweetch app registration instructions. The app delivered personalized push notifications for weight management, physical activity (PA), and nutrition, informed by both actively collected data (e.g., weight measurements, meal logging) and passively collected data (e.g., geolocation, accelerometry). PA was tracked via smartphone or wearable devices, meals were logged through a food library or photo-based detection, and weight was recorded either automatically through the scale or manually. The AI used in the Sweetch intervention consisted of a reinforcement learning algorithm that did not employ large language models. It personalized messaging by continuously learning which prompts, timing, and content elicited greater user engagement. The app also delivered location- and goal-specific nutrition education and included gamification elements and educational resources. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 14, 2023 |
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|
| Human Coach-based Diabetes Prevention Program (hDPP) | Behavioral | The Human Coach-Based Diabetes Prevention Program will consist of a CDC recognized lifestyle change program. Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach. |
|
| 12 months |
| Change in Hemoglobin A1C | Change in HbA1C (percentage points) from baseline to 12 months (among participants with baseline HbA1C of 5.7% - 6.4% who completed the 12-month study visit). | At 12 months |
| Percentage Change in Weight | Percentage change in weight from baseline to 12 months | At 12 months |
| Mean Weekly Moderate-to-vigorous Physical Activity (MVPA) | Average minutes/week of physical activity assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period). If the participant did not wear their monitor for at least 5 of their 7 assigned days, they were considered noncompliant. In this case, the participant was assigned 0 minutes for physical activity for that week.To obtain the average MVPA minutes per week across the study period, the total MVPA minutes per week from all valid wear periods were summed and divided by the number of available wear periods (maximum of 11 post-baseline visits). Specifically, activity intensity was classified as MVPA if the vector magnitude of accelerometer counts per minute was equal to or greater than 3941 (Montoye's cut point). | At 12 months |
| Incidence of Diabetes-range A1C | Number of individuals who had an AIC in the diabetes range (A1C ≥6.5%) at the 6-month or 12-month timepoint. | At either 6 or 12 months |
| Acceptability as Assessed by the 32-item Acceptability Questionnaire | To compare the acceptability of the two interventions (satisfaction, utility, interest, motivation, user experience, etc.) using the 32-item acceptability questionnaire. Scoring: Sum up all responses to questions 1-31, divide by 155 and multiply by 100 to calculate percentage score out of 100%. The range of possible scores is 20% (lowest acceptability) to 100% (highest possible acceptability). | 12 months |
| Correlation Between Self-reported and Measured Physical Activity | To evaluate the correlation between self-reported PA data collected using different methods:
| 6 months and 12 months |
| Program Initiation Rate | Program initiators were defined as participants who attended at least one in-person session (Human-DPP) or registered and used the Sweetch app (AI-DPP). | At 12 months |
| Program Completion Rate | Program completers attended ≥8 sessions in months 1-6 and spanned ≥9 months (Human-DPP), or engaged with the app for ≥8 weeks during months 1-6 with a span of ≥9 months between initiation and last engagement (AI-DPP). | At 12 months |
| Reading |
| Pennsylvania |
| 19611 |
| United States |
| FG001 | Human Coach-Based Diabetes Prevention Program (Human-DPP) | Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences). Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Intelligence-Based Diabetes Prevention Program (AI-DPP) | Participants in the AI-DPP group were referred to Sweetch Health, Ltd, and received a digital health kit from within 8-12 days post-randomization, which included a Bluetooth scale and Sweetch app registration instructions. The app delivered personalized push notifications for weight management, physical activity (PA), and nutrition, informed by both actively collected data (e.g., weight measurements, meal logging) and passively collected data (e.g., geolocation, accelerometry). PA was tracked via smartphone or wearable devices, meals were logged through a food library or photo-based detection, and weight was recorded either automatically through the scale or manually. The AI used in the Sweetch intervention consisted of a reinforcement learning algorithm that did not employ large language models. It personalized messaging by continuously learning which prompts, timing, and content elicited greater user engagement. The app also delivered location- and goal-specific nutrition education and included gamification elements and educational resources. |
| BG001 | Human Coach-Based Diabetes Prevention Program (Human-DPP) | Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences). Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Educational Attainment | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Median | Inter-Quartile Range | Kg/m^2 |
| |||||||||||||||
| Dyslipidemia | Participants with condition are reported | Count of Participants | Participants | No |
| ||||||||||||||
| Hypertension | Participants with condition are reported | Count of Participants | Participants | No |
| ||||||||||||||
| Back Pain | Participants with condition are reported | Count of Participants | Participants | No |
| ||||||||||||||
| Mood Disorder | Count of Participants | Participants |
| ||||||||||||||||
| Osteoarthritis | Participants with condition are reported | Count of Participants | Participants | No |
| ||||||||||||||
| Asthma/COPD | Count of Participants | Participants |
| ||||||||||||||||
| BMI Classification | Overweight (BMI 25.0 - 29.9 Kg/m^2); Class I Obesity (BMI 30.0 - 34.9 Kg/m^2); Class II Obesity (BMI 35.0 - 39.9 Kg/m^2); Class III Obesity (BMI >= 40.0 Kg/m^2); | Count of Participants | Participants |
| |||||||||||||||
| A1C | Mean | Standard Deviation | % |
| |||||||||||||||
| Actigraph Measured Moderate-to-Vigorous Physical Activity (MVPA) | Actigraph-measured MVPA refers to objectively measured moderate-to-vigorous physical activity using a wrist-worn accelerometer. <150 min/week corresponds to not meeting the recommended PA guidelines for prediabetes. | Median | Inter-Quartile Range | Minutes per Week |
| ||||||||||||||
| Actigraphy-measured MVPA <150 min/week | Moderate-to-vigorous PA (MVPA) <150 min/week corresponds to not meeting the recommended PA guidelines for prediabetes. | Count of Participants | Participants |
| |||||||||||||||
| Diet Quality | Diet quality at baseline was scored using the Starting the Conversation dietary survey, with lower schools indicating healthier dietary patterns. Scores range from 0 to 16, based on responses to 8 items assessing key dietary patterns. | Count of Participants | Participants | No |
|
| 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 | Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) | The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following:
| Posted | Sep 2025 | Count of Participants | Participants | 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Weight Change | Absolute weight change (kilograms) from baseline to 12 months | Posted | Median | Inter-Quartile Range | Kg | At 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cost-effectiveness as Assessed by the Markov Model | The investigators will compare the cost-effectiveness of the two interventions based on lifetime horizon by constructing a Markov model with model parameters populated from the trial results as well as other published literature. The model will estimate the incremental cost-effectiveness ratio between the two interventions. | Not Posted | Jun 2026 | 12 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1C | Change in HbA1C (percentage points) from baseline to 12 months (among participants with baseline HbA1C of 5.7% - 6.4% who completed the 12-month study visit). | Per-protocol analysis included participants with available 12-month outcome data who did not initiate prohibited medications during the trial. Change in A1C analysis was restricted to participants whose baseline A1C at randomization was between 5.7% and 6.4%. | Posted | Median | Inter-Quartile Range | Percentage of Total Hemoglobin | At 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Weight | Percentage change in weight from baseline to 12 months | Posted | Median | Inter-Quartile Range | percentage change | At 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Weekly Moderate-to-vigorous Physical Activity (MVPA) | Average minutes/week of physical activity assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period). If the participant did not wear their monitor for at least 5 of their 7 assigned days, they were considered noncompliant. In this case, the participant was assigned 0 minutes for physical activity for that week.To obtain the average MVPA minutes per week across the study period, the total MVPA minutes per week from all valid wear periods were summed and divided by the number of available wear periods (maximum of 11 post-baseline visits). Specifically, activity intensity was classified as MVPA if the vector magnitude of accelerometer counts per minute was equal to or greater than 3941 (Montoye's cut point). | Posted | Median | Inter-Quartile Range | Minutes per Week | At 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Diabetes-range A1C | Number of individuals who had an AIC in the diabetes range (A1C ≥6.5%) at the 6-month or 12-month timepoint. | Posted | Count of Participants | Participants | At either 6 or 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acceptability as Assessed by the 32-item Acceptability Questionnaire | To compare the acceptability of the two interventions (satisfaction, utility, interest, motivation, user experience, etc.) using the 32-item acceptability questionnaire. Scoring: Sum up all responses to questions 1-31, divide by 155 and multiply by 100 to calculate percentage score out of 100%. The range of possible scores is 20% (lowest acceptability) to 100% (highest possible acceptability). | Not Posted | May 2026 | 12 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Self-reported and Measured Physical Activity | To evaluate the correlation between self-reported PA data collected using different methods:
| Not Posted | May 2026 | 6 months and 12 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Program Initiation Rate | Program initiators were defined as participants who attended at least one in-person session (Human-DPP) or registered and used the Sweetch app (AI-DPP). | Posted | Count of Participants | Participants | At 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Program Completion Rate | Program completers attended ≥8 sessions in months 1-6 and spanned ≥9 months (Human-DPP), or engaged with the app for ≥8 weeks during months 1-6 with a span of ≥9 months between initiation and last engagement (AI-DPP). | Posted | Count of Participants | Participants | At 12 months |
|
From enrollment until the end of follow-up (12-month visit)
Grade 1: mild, asymptomatic, or mild symptoms; clinical or diagnostic observations only; no intervention required;Grade 2: moderate, requiring minimal or local intervention;Grade 3: severe or medically significant but not immediately life-threatening, necessitating hospitalization or prolongation of hospitalization; disabling; limits self-care activities of daily living;Grade 4: life-threatening consequences requiring urgent intervention;Grade 5: death related to the adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Artificial Intelligence-Based Diabetes Prevention Program (AI-DPP) | Participants in the AI-DPP group were referred to Sweetch Health, Ltd, and received a digital health kit from within 8-12 days post-randomization, which included a Bluetooth scale and Sweetch app registration instructions. The app delivered personalized push notifications for weight management, physical activity (PA), and nutrition, informed by both actively collected data (e.g., weight measurements, meal logging) and passively collected data (e.g., geolocation, accelerometry). PA was tracked via smartphone or wearable devices, meals were logged through a food library or photo-based detection, and weight was recorded either automatically through the scale or manually. The AI used in the Sweetch intervention consisted of a reinforcement learning algorithm that did not employ large language models. It personalized messaging by continuously learning which prompts, timing, and content elicited greater user engagement. The app also delivered location- and goal-specific nutrition education and included gamification elements and educational resources. | 0 | 183 | 36 | 183 | 10 | 183 |
| EG001 | Human Coach-Based Diabetes Prevention Program (Human-DPP) | Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences). Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial. | 0 | 185 | 6 | 185 | 3 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block | Cardiac disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Fracture of ankle | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Appendicitis | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 4, not related |
|
| Breast malignant tumors | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Terms | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Phacoemulsification | Eye disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Chest Pain | Cardiac disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Diabetes mellitus | Endocrine disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Otalgia | Ear and labyrinth disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Flank pain | Renal and urinary disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Foot drop | Nervous system disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Foot surgery | Surgical and medical procedures | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Hammer toe surgery | Surgical and medical procedures | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Headache | Nervous system disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Diverticulum intestinal hemorrhagic | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Hip pain | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Meniscus injury | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Parkinson's disease | Nervous system disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Gallbladder perforation | Hepatobiliary disorders | MedDRA Terms | Non-systematic Assessment | Grade 4, not related |
|
| Prostate cancer stage 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 4, not related |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Retinal detachment | Eye disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Rotator cuff tear | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Stem cell transplant | Surgical and medical procedures | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Syncope | Nervous system disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Giant cell arteritis | Vascular disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Vertigo | Nervous system disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Wrist operation NOS | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment | Grade 3, not related |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA Terms | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Terms | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Terms | Non-systematic Assessment |
| |
| Foreign body in ear | Injury, poisoning and procedural complications | MedDRA Terms | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Terms | Non-systematic Assessment |
| |
| Generalized anxiety disorder | Psychiatric disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Terms | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Kidney stone | Renal and urinary disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Terms | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA Terms | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Terms | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Terms | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA Terms | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Terms | Non-systematic Assessment |
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This study has limitations. It was unmasked, relied on surrogate outcomes, and DPP delivery may have varied by site. App updates and study visits outside standard DPP exposures may have influenced outcomes. Referrals were not from primary care, and missing data or assumptions about physical activity had minimal sensitivity impacts. COVID-19 altered DPP delivery, and results may not generalize to broader prediabetes populations due to the sample's high activity levels and education.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nestoras Mathioudakis, MD MHS | Johns Hopkins University, School of Medicine | 667-306-8085 | nmathio1@jhmi.edu |
| Nov 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D040242 | Risk Reduction Behavior |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
Not provided
Not provided
| Male |
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| Asian |
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| Black or African American |
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| White or Caucasian |
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| More than One Race |
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| Other |
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| Declined to Answer |
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| Hispanic or Latino |
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| Declined to Answer |
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| Unknown |
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| Previously Married |
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| Single/Other |
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| Some College/Associate's Degree |
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| Bachelor's Degree |
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| Graduate/Professional Degree |
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| Declined to Answer |
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| Class I Obesity |
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| Class II Obesity |
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| Class III Obesity |
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| Moderately Healthy Diet (6-10) |
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| Least Healthy Diet (11-16) |
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| OG001 | Human Coach-Based Diabetes Prevention Program (Human-DPP) | Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences). Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial. |
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| OG001 | Human Coach-Based Diabetes Prevention Program (Human-DPP) | Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences). Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial. |
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Participants in the Human-DPP group were referred to one of four 12-month accredited lifestyle change programs: Brancati Center and University of Maryland Medical Center (Baltimore, MD), Pottstown Medical Specialists and Montgomery County DPP (Reading, PA). All four participating DPPs had full plus recognition status from the CDC. Due to COVID-19, all sessions transitioned to synchronous distance learning (i.e., group video conferences).
Trained lifestyle coaches led sessions based on the CDC's PreventT2 curriculum, covering healthy eating, food tracking, PA, behavior modification, and long-term weight management, with an initial core phase (16 weekly sessions) and a remaining core maintenance phase (bi-weekly to monthly sessions) to complete the 12-month intervention. Of note, our study participants joined DPP cohorts that were comprised of standard enrollees who were not participants in our trial.
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