Clinical trial NCT05056376: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-09-24
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)
timeFrame: 12 months
Secondary outcomes:
measure: Cost-effectiveness as assessed by the Markov model
timeFrame: 12 months
measure: Change in hemoglobin A1C
timeFrame: Baseline, 6 months and 12 months
measure: Percentage weight change
timeFrame: Baseline, 6 months and 12 months
measure: Absolute weight change
timeFrame: Baseline, 6 months and 12 months
measure: Change in physical activity - average minutes/week of physical activity
timeFrame: Baseline, 6 months and 12 months
measure: Change in physical activity - hours per week of physical activity
timeFrame: Baseline, 6 months and 12 months
measure: Change in physical activity - average number of steps per day
timeFrame: Baseline, 6 months and 12 months
measure: Engagement with programs as assessed by a score out of 100%
timeFrame: 6 months
measure: Engagement with programs as assessed by a score out of 100%
timeFrame: 12 months
measure: Incidence of type 2 diabetes
timeFrame: 6 months
measure: Incidence of type 2 diabetes
timeFrame: 12 months
measure: Acceptability as assessed by the 32-item acceptability questionnaire
timeFrame: 6 months
measure: Acceptability as assessed by the 32-item acceptability questionnaire
timeFrame: 12 months
measure: Correlation between self-reported and measured physical activity
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Reading
country: United States
facility: Reading Hospital - Tower Health
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Nestoras Mathioudakis, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: