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

Primary Purpose

PreDiabetes, Hyperglycemia, Glucose, High Blood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Diabetes Prevention Program (dDPP)
Human Coach-based Diabetes Prevention Program (hDPP)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Prediabetes, Diabetes Prevention Program, DPP, Obesity, Overweight, Physical Activity, Digital, Artificial Intelligence, Weight

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Johns Hopkins HospitalRecruiting
  • Reading Hospital - Tower HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fully-Automated Digital Diabetes Prevention Program

Human Coach-Based Diabetes Prevention Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)
The achievement is defined as attainment of one or more of the following: At least 5% weight loss at 12 months. 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) 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

Cost-effectiveness as assessed by the Markov model
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.
Change in hemoglobin A1C
Change in HbA1C (percentage) from baseline to 6 months and 12 months
Percentage weight change
Percentage weight (percent) change from baseline to 6 and 12 months
Absolute weight change
Absolute weight change (kilograms) from baseline to 6 and 12 months
Change in physical activity - average minutes/week of physical activity
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.
Change in physical activity - hours per week of physical activity
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.
Change in physical activity - average number of steps per day
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.
Engagement with programs as assessed by a score out of 100%
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.
Engagement with programs as assessed by a score out of 100%
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
Incidence of type 2 diabetes
Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).
Incidence of type 2 diabetes
Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).
Acceptability as assessed by the 32-item acceptability questionnaire
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).
Acceptability as assessed by the 32-item acceptability questionnaire
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).
Correlation between self-reported and measured physical activity
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

Full Information

First Posted
September 14, 2021
Last Updated
May 24, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05056376
Brief Title
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Official Title
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Hyperglycemia, Glucose, High Blood, Overweight, Prediabetic State, Impaired Glucose Tolerance, Obesity, Weight Loss, Lifestyle, Healthy, Lifestyle Risk Reduction, Lifestyle, Sedentary
Keywords
Prediabetes, Diabetes Prevention Program, DPP, Obesity, Overweight, Physical Activity, Digital, Artificial Intelligence, Weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fully-Automated Digital Diabetes Prevention Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Human Coach-Based Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital Diabetes Prevention Program (dDPP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Human Coach-based Diabetes Prevention Program (hDPP)
Intervention Description
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 Measure Information:
Title
Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)
Description
The achievement is defined as attainment of one or more of the following: At least 5% weight loss at 12 months. 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) 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%).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness as assessed by the Markov model
Description
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.
Time Frame
12 months
Title
Change in hemoglobin A1C
Description
Change in HbA1C (percentage) from baseline to 6 months and 12 months
Time Frame
Baseline, 6 months and 12 months
Title
Percentage weight change
Description
Percentage weight (percent) change from baseline to 6 and 12 months
Time Frame
Baseline, 6 months and 12 months
Title
Absolute weight change
Description
Absolute weight change (kilograms) from baseline to 6 and 12 months
Time Frame
Baseline, 6 months and 12 months
Title
Change in physical activity - average minutes/week of physical activity
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in physical activity - hours per week of physical activity
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in physical activity - average number of steps per day
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Engagement with programs as assessed by a score out of 100%
Description
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.
Time Frame
6 months
Title
Engagement with programs as assessed by a score out of 100%
Description
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
Time Frame
12 months
Title
Incidence of type 2 diabetes
Description
Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).
Time Frame
6 months
Title
Incidence of type 2 diabetes
Description
Percentage of individuals who develop type 2 diabetes (A1C ≥6.5%).
Time Frame
12 months
Title
Acceptability as assessed by the 32-item acceptability questionnaire
Description
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).
Time Frame
6 months
Title
Acceptability as assessed by the 32-item acceptability questionnaire
Description
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).
Time Frame
12 months
Title
Correlation between self-reported and measured physical activity
Description
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
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nestoras Mathioudakis, MD MHS
Phone
6673068085
Email
nmathio1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Abusamaan, MD MPH
Phone
4439271309
Email
mabusamaan@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestoras Mathioudakis, MD MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nestoras N Mathioudakis, MD
Phone
667-306-8085
Email
nmathio1@jh.edu
First Name & Middle Initial & Last Name & Degree
Mohammed S Abusamaan, MD
Phone
443-927-1309
Email
mabusamaan@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Nestoras N Mathioudakis, MD
First Name & Middle Initial & Last Name & Degree
Mohammed S Abusamaan, MD
First Name & Middle Initial & Last Name & Degree
Adrian Dobs, MD
First Name & Middle Initial & Last Name & Degree
Amal Wanigatunga, PhD
First Name & Middle Initial & Last Name & Degree
Kristen Riekert, PhD
First Name & Middle Initial & Last Name & Degree
John McGready, PhD
First Name & Middle Initial & Last Name & Degree
Nisa Maruthur, MD
Facility Name
Reading Hospital - Tower Health
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Marrero
Phone
484-628-8355
Email
Pamela.marrero@towerhealth.org
First Name & Middle Initial & Last Name & Degree
Mary Elderfer
Phone
484-628-8360
Email
mary.elderfer@towerhealth.org
First Name & Middle Initial & Last Name & Degree
Brian Kane, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
The study protocol will be submitted for publication within 1 year of the start of enrollment.
Links:
URL
https://www.nestorasmathioudakislab.com/prediabetesresearchstudy
Description
Study Website

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

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