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临床试验/NCT02896010
NCT02896010已完成不适用

Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes: Rationale and Study Protocol - Pilot Study

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
4
主要终点
Yield of Recruitment

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 GPS (Global Positioning System) 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
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Adults aged 18 -75 years with prediabetes (fasting 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

Active Comparator

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

Active Comparator

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

Yield of Recruitment

时间窗: 3 months

Proportion of recruited participants who enroll and complete the 3 month study

次要结局

  • Engagement(3 months)
  • Usability and Satisfaction(3 months)
  • Adherence to physical activity goal(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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