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Completed

NCT Number: NCT05056376

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

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.

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Key information

Conditions

PreDiabetes Behavior Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Glucose, High Blood Hyperglycemia Impaired Glucose Tolerance Lifestyle Risk Reduction Lifestyle, Healthy Lifestyle, Sedentary Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Risk Reduction Behavior Sedentary Behavior Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)

    Time frame: 12 months

    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:

    • Weight loss of ≥5%.
    • Weight loss of ≥4% combined with at least 150 weekly minutes of moderate-to-vigorous PA
    • An absolute decrease of ≥0.2 points in A1C (measured in %). The A1C endpoint was applicable only to participants with baseline A1C of 5.7% to 6.4%. Maintaining an A1C <6.5% throughout the study was also a criterion for the primary outcome.

Secondary outcomes

  1. Absolute Weight Change

    Time frame: At 12 months

    Absolute weight change (kilograms) from baseline to 12 months

  2. Cost-effectiveness as Assessed by the Markov Model

    Time frame: 12 months

    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.

  3. Change in Hemoglobin A1C

    Time frame: At 12 months

    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).

  4. Percentage Change in Weight

    Time frame: At 12 months

    Percentage change in weight from baseline to 12 months

  5. Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)

    Time frame: At 12 months

    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).

  6. Incidence of Diabetes-range A1C

    Time frame: At either 6 or 12 months

    Number of individuals who had an AIC in the diabetes range (A1C ≥6.5%) at the 6-month or 12-month timepoint.

  7. Acceptability as Assessed by the 32-item Acceptability Questionnaire

    Time frame: 12 months

    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).

  8. Correlation Between Self-reported and Measured Physical Activity

    Time frame: 6 months and 12 months

    To evaluate the correlation between self-reported PA data collected using different methods:

    • Data collected and reported by hDPPs
    • Self-reported PA data collected by study team obtained at 1-month intervals
    • Objectively measured PA data (Actigraphy) obtained at 1-month intervals

  9. Program Initiation Rate

    Time frame: At 12 months

    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).

  10. Program Completion Rate

    Time frame: At 12 months

    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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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