Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Trial ID: NCT05056376
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-10-01
Completion date: 2024-12-16
Sponsor: Johns Hopkins University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: PreDiabetes; Hyperglycemia; Glucose, High Blood; Overweight; Prediabetic State; Impaired Glucose Tolerance; Obesity; Weight Loss; Lifestyle, Healthy; Lifestyle Risk Reduction; Lifestyle, Sedentary
Interventions: Digital Diabetes Prevention Program (dDPP); Human Coach-based Diabetes Prevention Program (hDPP)
Locations: Johns Hopkins Hospital; Reading Hospital - Tower Health
Countries: United States; United States
Enrollment: 368
Age range: 18 Years - 75 Years
Sex: ALL

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.

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:

  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 \~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.

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