Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
NCT ID: NCT05056376
Last Updated: 2025-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2021-10-01
2024-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Fully-Automated Digital Diabetes Prevention Program
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.
Digital Diabetes Prevention Program (dDPP)
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.
Human Coach-Based Diabetes Prevention 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.
Human Coach-based Diabetes Prevention Program (hDPP)
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.
Interventions
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Digital Diabetes Prevention Program (dDPP)
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.
Human Coach-based Diabetes Prevention Program (hDPP)
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.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Hemoglobin A1C 5.7% to 6.4%
2. Fasting glucose 100-125 mg/dL
3. Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load
* 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
* Aortic stenosis.
* Unstable cardiac disease (myocardial infarction, heart failure, or stroke in previous 6 months, currently participating in cardiac rehabilitation).
* Has a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device.
* Use of any glucose-lowering medications, weight loss medications, or any systemic glucocorticoids within the previous 3 months.
* Active malignancy of any type or diagnosed with or treated for cancer within the past 2 years. Individuals with basal and squamous cell carcinoma of the skin that has been successfully treated will be allowed to participate.
* Diagnosis of diabetes mellitus.
* Pregnancy or planned pregnancy in the next 12 months.
* Anemia.
* Receiving treatment for iron-deficiency anemia, vitamin B12 deficiency, or folate d efficiency.
* Hemoglobinopathy (HbS or HbC disease).
* Blood transfusion in previous 4 months.
* On dialysis or active organ transplant list.
* Treated with erythropoietin.
* Major psychiatric disorder (schizophrenia) or use of antipsychotic medications within the past 1 year.
* Dementia or Alzheimer's disease.
* Diagnosed with an eating disorder (anorexia nervosa, avoidant/restrictive food intake disorder, binge eating disorder, bulimia nervosa, Pica, rumination disorder, other specified or unspecified feeding or eating disorder)
* Diagnosed or self-reported alcohol or substance abuse.
* Known allergy to steel.
* Participation in another clinical trial related to lifestyle management or diabetes prevention.
* Currently attending or attended a diabetes prevention program in the previous 2 years.
* Unwilling to accept random assignments.
* Had bariatric surgery within the 12 months prior randomization or is planning to undergo bariatric surgery during the study.
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Nestoras Mathioudakis, MD MHS
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Reading Hospital - Tower Health
Reading, Pennsylvania, United States
Countries
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References
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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 Oct 27:e2519563. doi: 10.1001/jama.2025.19563. Online ahead of print.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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IRB00265873
Identifier Type: -
Identifier Source: org_study_id