Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05056376
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PreDiabetes Hyperglycemia Glucose, High Blood Overweight Prediabetic State Impaired Glucose Tolerance Obesity Weight Loss Lifestyle, Healthy Lifestyle Risk Reduction Lifestyle, Sedentary Behavioral: Digital Diabetes Prevention Program (dDPP) Behavioral: Human Coach-based Diabetes Prevention Program (hDPP) Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Arm Intervention/treatment
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.
Behavioral: 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, p revious response, calendar availability, and weather, etc.


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.
Behavioral: 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.




Primary Outcome Measures :
  1. Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no) [ Time Frame: 12 months ]

    The achievement is defined as attainment of one or more of the following:

    1. At least 5% weight loss at 12 months.
    2. At least 4% weight loss at 12 months and at least 150 minutes/week of physical activity (measured using monthly serial Actigraphy and averaged over months 1-11)
    3. At least 0.2% reduction in A1C at 12 months (for participants whose A1C result obtained at baseline study visit is between 5.7% and 6.4%).


Secondary Outcome Measures :
  1. 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.

  2. Change in hemoglobin A1C [ Time Frame: Baseline, 6 months and 12 months ]
    Change in HbA1C (percentage) from baseline to 6 months and 12 months

  3. Percentage weight change [ Time Frame: Baseline, 6 months and 12 months ]
    Percentage weight (percent) change from baseline to 6 and 12 months

  4. Absolute weight change [ Time Frame: Baseline, 6 months and 12 months ]
    Absolute weight change (kilograms) from baseline to 6 and 12 months

  5. Change in physical activity - average minutes/week of physical activity [ Time Frame: Baseline, 6 months and 12 months ]
    Change in physical activity measure (average minutes/week of physical activity) assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period) from baseline to 6 months and 12 months.

  6. Change in physical activity - hours per week of physical activity [ Time Frame: Baseline, 6 months and 12 months ]
    Change in physical activity measure (metabolic equivalent task (MET)-hours per week of physical activity) assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period) from baseline to 6 months and 12 months.

  7. Change in physical activity - average number of steps per day [ Time Frame: Baseline, 6 months and 12 months ]
    Change in physical activity measures (average number of steps per day) assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period) from baseline to 6 months and 12 months.

  8. Engagement with programs as assessed by a score out of 100% [ Time Frame: 6 months ]
    To compare engagement with digital vs. human coach-based DPPs and evaluate whether between-group differences in clinical outcomes are mediated by engagement, the investigators will define an engagement score (out of 100%) for the hDPP based on the percentage of total number of sessions attended, using the most current CDC engagement definitions at the time of completion of the study. Percentage engagement will be defined out of a total of 8 sessions in month 1-6. An engagement score (out of 100%) for the dDPPs will based on percentage of full weeks during which the app is installed and a) both push notifications and motion sensors are enabled or b) the participant accesses any component within the app for months 1-6.

  9. Engagement with programs as assessed by a score out of 100% [ Time Frame: 12 months ]
    To compare engagement with digital vs. human coach-based DPPs and evaluate whether between-group differences in clinical outcomes are mediated by engagement, the investigators will define an engagement score (out of 100%) for the hDPP based on the percentage of total number of sessions attended, using the most current CDC engagement definitions at the time of completion of the study. Percentage engagement will be defined out of a total of 3 sessions in month 7-12. An engagement score (out of 100%) for the dDPPs will based on percentage of full weeks during which the app is installed and a) both push notifications and motion sensors are enabled or b) the participant accesses any component within the app for months 7-12

  10. Incidence of type 2 diabetes [ Time Frame: 6 months ]
    Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).

  11. Incidence of type 2 diabetes [ Time Frame: 12 months ]
    Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).

  12. Acceptability as assessed by the 32-item acceptability questionnaire [ Time Frame: 6 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).


  13. 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).


  14. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    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 ~25 miles of both recruitment site and at least one participating local DPP).

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 rubber or 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 assignment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056376


Contacts
Layout table for location contacts
Contact: Nestoras Mathioudakis, MD MHS 6673068085 nmathio1@jhmi.edu
Contact: Mohammed Abusamaan, MD MPH 4439271309 mabusamaan@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nestoras N Mathioudakis, MD    667-306-8085    nmathio1@jh.edu   
Contact: Mohammed S Abusamaan, MD    443-927-1309    mabusamaan@jhmi.edu   
Principal Investigator: Nestoras N Mathioudakis, MD         
Sub-Investigator: Mohammed S Abusamaan, MD         
Sub-Investigator: Adrian Dobs, MD         
Sub-Investigator: Amal Wanigatunga, PhD         
Sub-Investigator: Kristen Riekert, PhD         
Sub-Investigator: John McGready, PhD         
Sub-Investigator: Nisa Maruthur, MD         
United States, Pennsylvania
Reading Hospital - Tower Health Recruiting
Reading, Pennsylvania, United States, 19611
Contact: Pamela Marrero    484-628-8355    Pamela.marrero@towerhealth.org   
Contact: Mary Elderfer    484-628-8360    mary.elderfer@towerhealth.org   
Principal Investigator: Brian Kane, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Nestoras Mathioudakis, MD MHS Johns Hopkins University
Additional Information:
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05056376    
Other Study ID Numbers: IRB00265873
1R01DK125780-01 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: The study protocol will be submitted for publication within 1 year of the start of enrollment.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Prediabetes
Diabetes Prevention Program
DPP
Obesity
Overweight
Physical Activity
Digital
Artificial Intelligence
Weight
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperglycemia
Prediabetic State
Glucose Intolerance
Overweight
Weight Loss
Body Weight
Body Weight Changes
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases