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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    368
  • sponsor
    Johns Hopkins University
Updated on 22 April 2022
diabetes
body mass index
fasting
hemoglobin a1c
plasma glucose
diabetes prevention

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.

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.

Details
Condition PreDiabetes, Hyperglycemia, Glucose, High Blood, Overweight, Prediabetic State, Impaired Glucose Tolerance, Obesity, Weight Loss, Lifestyle, Healthy, Lifestyle Risk Reduction, Lifestyle, Sedentary
Treatment Digital diabetes prevention program (dDPP), Human Coach-based Diabetes Prevention Program (hDPP)
Clinical Study IdentifierNCT05056376
SponsorJohns Hopkins University
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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%
Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians)
Proficiency in reading English
Fasting glucose 100-125 mg/dL
Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load
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
Unwilling to accept random assignment
Currently attending or attended a diabetes prevention program in the previous 2 years
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note