Effectiveness and Safety of a Smartphone-Assisted Personalized Intervention Program to Reduce Diabetes Risk in Adults With Prediabetes: a Multi-Center, Open-Label Randomized Controlled Trial - Main Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Effectiveness of Sweetch's PIP compared to usual care to lower A1C
研究概览
简要总结
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
详细描述
The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and Global Positioning System (GPS) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Open Label
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
- •Adults aged 18 -75 years with prediabetes (fasting Blood Glucose (BG) 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
- •Body mass index 24 - 40 kg/m2
- •English speaker
- •Smartphone user (Android or Apple 5s and above)
排除标准
- •Currently doing more than 150 minutes/week of moderate/vigorous physical activity
- •Presence of medical conditions that prevent adoption of moderate physical activity
- •Use of any glucose-lowering or weight loss medications within the previous 3 months
- •Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
- •Presence of any condition that can result in spurious A1C readings (e.g. anemia [hemoglobin level below lower limit of normal] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
- •Use of systemic glucocorticoids
- •Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
- •Severe mental illness or learning disability
- •Current participation in another clinical trial
- •Liver enzymes >3 x upper limit of normal
- •Poor literacy (REALM-R score of 6 or less)
研究组 & 干预措施
Sweetch App + DBWS
Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app plus weight monitoring via digital body weight scale (DBWS).
干预措施: Sweetch App & DBWS (Other)
Sweetch App Alone
Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone.
干预措施: Sweetch App Alone (Other)
结局指标
主要结局
Effectiveness of Sweetch's PIP compared to usual care to lower A1C
时间窗: 2 years
A1C is a continuous measure expressed in units of % and mmol/mol. Change in A1C will be calculated by subtracting the 6-month result from the baseline result. The primary effectiveness endpoint will be analyzed using linear regression models, where change in A1C at 6 months will be the dependent variable and treatment group will be the primary predictor variable. The baseline value of the outcome measure will be included as a covariate.
Safety of Sweetch's PIP compared to usual care to lower A1C
时间窗: 2 years
Administration of study intervention will be halted when 3 grade 3 Adverse Events (AEs) determined to be "probably related" are reported to the Data Coordinating Center (DCC). The DCC will notify study sponsor \& investigators immediately when the third grade 3 event is reported \& enrollment screens will stop accepting new study participants. Study sponsor will inform the Data Safety and Monitoring Board (DSMB) members within 24 hours of this occurrence \& will provide DSMB with AE listing reports. The DSMB will convene an ad hoc meeting by teleconference or in writing as soon as possible. The DSMB will provide recommendations for proceeding with the study to study sponsor. If Sweetch Health determines that an unanticipated adverse device effect presents an unreasonable risk to subjects, investigations or parts of investigations presenting that risk will be terminated as soon as possible.
次要结局
- Evaluation of whether intervention reduces weight.(12 months)
- Evaluation of whether intervention reduces waist circumference.(12 months)
- Evaluation of whether intervention reduces blood pressure.(12 months)
- Evaluation of whether intervention increases physical activity.(12 months)
