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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05056376
• Other study ID #: IRB00265873
• Secondary ID: 1R01DK125780-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose, High Blood
• Hyperglycemia
• Impaired Glucose Tolerance
• Lifestyle Risk Reduction
• Lifestyle, Healthy
• Lifestyle, Sedentary
• Obesity
• Overweight
• PreDiabetes
• Prediabetic State
• Weight Loss

Intervention

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, previous response, calendar availability, and weather, etc.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Reading Hospital - Tower Health	Reading	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).	12 months
Secondary	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.	12 months
Secondary	Change in hemoglobin A1C	Change in HbA1C (percentage) from baseline to 6 months and 12 months	Baseline, 6 months and 12 months
Secondary	Percentage weight change	Percentage weight (percent) change from baseline to 6 and 12 months	Baseline, 6 months and 12 months
Secondary	Absolute weight change	Absolute weight change (kilograms) from baseline to 6 and 12 months	Baseline, 6 months and 12 months
Secondary	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.	Baseline, 6 months and 12 months
Secondary	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.	Baseline, 6 months and 12 months
Secondary	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.	Baseline, 6 months and 12 months
Secondary	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.	6 months
Secondary	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	12 months
Secondary	Incidence of type 2 diabetes	Percentage of individuals who develop type 2 diabetes (A1C =6.5%).	6 months
Secondary	Incidence of type 2 diabetes	Percentage of individuals who develop type 2 diabetes (A1C =6.5%).	12 months
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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	6 months and 12 months

External Links

•   Study Website