Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05056376
Status
Completed

Conditions

  • Glucose, High Blood
  • Hyperglycemia
  • Impaired Glucose Tolerance
  • Lifestyle Risk Reduction
  • Lifestyle, Healthy
  • Lifestyle, Sedentary
  • Obesity
  • Overweight
  • PreDiabetes
  • Prediabetic State
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Dec 2025
Primary completion
Dec 16, 2024
Completion
Dec 16, 2024

Study Design

Enrollment
368 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-
Reading Hospital - Tower HealthReadingPennsylvania19611-

Find similar trials in Baltimore, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins Hospital· Baltimore, MDReading Hospital - Tower Health· Reading, PA

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