Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic Dysfunction-Associated Steatotic Liver DiseaseTesting a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic-dysfunction Associated Steatotic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
The purpose of this study is to understand if a behavioral lifestyle intervention called the Healthy Liver/Hígado Sano program can help Hispanic/Latino patients with metabolic dysfunction associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease (NAFLD), lose weight and improve their liver health
详细描述
This feasibility study will use a quasi-experimental design to test an adapted multilevel intervention with Hispanic/Latino adults with metabolic dysfunction-associated steatotic liver disease at an intervention clinic, compared to similar participants at an observational clinic receiving usual care. The investigators will collect and analyze quantitative and qualitative data, specifically, clinical/biometric, anthropometric, behavioral, and psychosocial assessments at baseline, 6, and 12 months at the individual level, and additionally collect data from family members, providers/staff, and community health workers/social workers. At the end of the study, the investigators will also conduct in-depth interviews to contextualize quantitative results and gain deeper insights into intervention experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 MASLD
- •Be an adult >= 18 years of age
- •Able to speak English or Spanish
- •Have a working telephone number
- •Have access to internet, either on their phone, at home or at some other location convenient to the participant
- •Have a family member willing to attend all sessions
排除标准
- •Taking a GLP-1 receptor agonist or dual agonist at the time of enrollment, or plans to being taking one in the next 6 months
研究组 & 干预措施
Healthy Liver/Hígado Sano program
干预措施: Healthy Liver/Hígado Sano program (Behavioral)
Usual Care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Recruitment Feasibility
时间窗: Baseline
Recruitment will be assessed to be feasible if ≥65% of eligible participants enroll in the study
Retention
时间窗: 6 months, 12 months
Percent of participants who complete follow-up data collection
Adherence
时间窗: 6 months
Intervention participants who attend education sessions
Participant satisfaction
时间窗: 6 months
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument assessing satisfaction with services received. Each item is rated on a 4-point Likert scale (1 = least satisfied, 4 = most satisfied). Item scores are summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction.
次要结局
- Fasting glucose levels(Baseline, 6 months, 12 months)
- Self-reported Physical Activity(Baseline, 6 months, 12 months)
- Accelerometer-assessed physical activity(Baseline, 6 months, 12 months)
- Diet(Baseline, 6 months, 12 months)
- Weight(Baseline, 6 months, 12 months)
- Liver steatosis and/or stiffness(Baseline, 6 months, 12 months)
研究者
Natalia Heredia
Assistant Professor
The University of Texas Health Science Center, Houston