- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05056376
Efficacité et rentabilité des programmes de prévention du diabète entièrement automatisés, numériques ou humains
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins Hospital
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Pennsylvania
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Reading, Pennsylvania, États-Unis, 19611
- Reading Hospital - Tower Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Provision of signed and dated informed consent form.
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Stated willingness to comply with all study procedures and availability for the duration of the study.
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Laboratory evidence of prediabetes, defined as any of the following lab results, in the past year:
- Hemoglobin A1C 5.7% to 6.4%
- Fasting glucose 100-125 mg/dL
- Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load
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Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians).
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Proficiency in reading English.
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Smartphone user (Android Operating System (OS) 9.0 or iOS 13.3 or newer).
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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:
- Medical conditions that prevent adoption of moderate physical activity (per primary care clinician).
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
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. |
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Comparateur actif: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)
Délai: 12 months
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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:
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Absolute Weight Change
Délai: At 12 months
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Absolute weight change (kilograms) from baseline to 12 months |
At 12 months
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Cost-effectiveness as Assessed by the Markov Model
Délai: 12 months
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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. |
12 months
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Change in Hemoglobin A1C
Délai: At 12 months
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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
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Percentage Change in Weight
Délai: At 12 months
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Percentage change in weight from baseline to 12 months |
At 12 months
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Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)
Délai: At 12 months
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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
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Incidence of Diabetes-range A1C
Délai: At either 6 or 12 months
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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
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Acceptability as Assessed by the Diabetes Prevention Program Acceptability Scale (DPPAS)
Délai: 12 months
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Acceptability of the assigned intervention was assessed at 12 months using the Diabetes Prevention Program Acceptability Scale (DPPAS), Score range from 1 to 5; higher scores indicate greater acceptability (better outcome). |
12 months
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Correlation Between Self-reported and Measured Physical Activity
Délai: 6 months and 12 months
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To evaluate the correlation between self-reported PA data collected using different methods:
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6 months and 12 months
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Program Initiation Rate
Délai: At 12 months
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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
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Program Completion Rate
Délai: At 12 months
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nestoras Mathioudakis, MD MHS, Johns Hopkins University
Publications et liens utiles
Publications générales
- 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.
- Lalani B, Siew G, Valdez Y, Shehadeh A, Zade D, Riekert K, Mathioudakis N; AI-DPP Study Group. User Engagement and Feature Preferences in an AI-Powered mHealth Intervention for Diabetes Prevention: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Sep 2;14:e92981. doi: 10.2196/92981.
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Changements de poids corporel
- Troubles du métabolisme du glucose
- Diabète sucré
- Conditions pathologiques, signes et symptômes
- Comportement
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Obésité
- Perte de poids
- Poids
- Hyperglycémie
- État prédiabétique
- Intolérance au glucose
- Activité motrice
- Comportement sédentaire
- Comportement de réduction des risques
Autres numéros d'identification d'étude
- IRB00265873
- 1R01DK125780-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
The study protocol will be submitted for publication within 1 year of the start of enrollment.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .