Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- The University of Michigan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
- Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
- Ability to participate in physical activity
Exclusion Criteria:
- Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
- History of decompensated cirrhosis
- Plans for invasive procedures or other regimented lifestyle programs for weight reduction
- Cardiovascular event in the previous 3 months
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Usual Care then FitBit
This is the waitlist control arm.
|
Usual care is a visit (15-20 mins) every 6-12 months.
Usual care includes a Fibroscan (FDA 510(k) device).
Intervention is tailored physical activity and nutritional counseling.
Step counts are monitored by a FitBit Zip.
A Fibroscan (FDA 510(k) device) is done.
|
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实验性的：FitBit then Usual Care
Intervention includes education, physical activity, and a nutrition assessment.
|
Usual care is a visit (15-20 mins) every 6-12 months.
Usual care includes a Fibroscan (FDA 510(k) device).
Intervention is tailored physical activity and nutritional counseling.
Step counts are monitored by a FitBit Zip.
A Fibroscan (FDA 510(k) device) is done.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
大体时间：Baseline, 6 months,
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CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat). Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP 12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation. |
Baseline, 6 months,
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Body Weight
大体时间：Baseline, 6 months
|
Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline
|
Baseline, 6 months
|
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Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
大体时间：Baseline, 6 months
|
The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500. Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active. Insufficient paired results existed to provide percent change measurements. Medians overall are provided. |
Baseline, 6 months
|
合作者和调查者
调查人员
- 首席研究员：Monica Konerman、University of Michigan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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