NCT05200585已完成不适用
Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of participants recruited
研究概览
简要总结
The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported Hispanic/Latino
- •Have been diagnosed with NAFLD
- •Able to speak English or Spanish
- •Have access to internet, either on their phone, at home or at some other location convenient to the participant
排除标准
- •Does not have a working telephone number
结局指标
主要结局
Number of participants recruited
时间窗: end of study(6 months after enrollment)
Number of participants that adhere to the intervention
时间窗: end of study(6 months after enrollment)
Number of participants that complete the study
时间窗: end of study(6 months after enrollment)
Intervention group participants Satisfaction of program as assessed by the Client Satisfaction Questionnaire (CSQ-8)
时间窗: end of study(6 months after enrollment)
The Client Satisfaction Questionnaire (CSQ) has 8 items.Each one is scored from 1-4, with a total possible score of 32, a higher score indicating greater satisfaction
次要结局
- Height of participants(Baseline, 6 months after enrollment)
- Change in liver function as assessed by alanine aminotransferase (ALT) levels(Baseline, 6 months after enrollment)
- Change in perceived severity(Baseline, 6 months after enrollment)
- Change in weight of participants(Baseline, 6 months after enrollment)
- Change in physical activity as assessed by the Actigraph GT9X accelerometers(Baseline, 6 months after enrollment)
- Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Unhealthy foods index(Baseline, 6 months after enrollment)
- Change in alcohol use as assessed by the alcohol use disorders identification test (AUDITC)(Baseline, 6 months after enrollment)
- Change in social support for physical activity as assessed by the Social Support for Exercise scales(Baseline, 6 months after enrollment)
- Change in liver function as assessed by the Fibrosis-4 (FIB-4) index(Baseline, 6 months after enrollment)
- Change in physical activity as assessed by the International Physical Activity Questionnaire(Baseline, 6 months after enrollment)
- Change in social support for diet as assessed by the Social Support for Diet scales(Baseline, 6 months after enrollment)
- Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Healthy foods index(Baseline, 6 months after enrollment)
- Change in participant illness perception as assessed by the brief Illness Perception Questionnaire(Baseline, 6 months after enrollment)
- Change in Perceived treatment efficacy(Baseline, 6 months after enrollment)
- Change in Stress as assessed by the 4 items Perceived Stress Scale(Baseline, 6 months after enrollment)
- Change in Depression as assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)(Baseline, 6 months after enrollment)
- Change in Anxiety as assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire.(Baseline, 6 months after enrollment)
研究者
Natalia Heredia
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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