Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 4
- 主要终点
- Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)
时间窗: 12 months
The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following: 1. Weight loss of ≥5%. 2. Weight loss of ≥4% combined with at least 150 weekly minutes of moderate-to-vigorous PA 3. An absolute decrease of ≥0.2 points in A1C (measured in %). The A1C endpoint was applicable only to participants with baseline A1C of 5.7% to 6.4%. Maintaining an A1C \<6.5% throughout the study was also a criterion for the primary outcome.
次要结局
- Absolute Weight Change(At 12 months)
- Cost-effectiveness as Assessed by the Markov Model(12 months)
- Change in Hemoglobin A1C(At 12 months)
- Percentage Change in Weight(At 12 months)
- Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)(At 12 months)
- Incidence of Diabetes-range A1C(At either 6 or 12 months)
- Acceptability as Assessed by the 32-item Acceptability Questionnaire(12 months)
- Program Initiation Rate(At 12 months)
- Correlation Between Self-reported and Measured Physical Activity(6 months and 12 months)
- Program Completion Rate(At 12 months)