A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Intervention delivery time at 12-months
研究概览
简要总结
Using a small Randomized Controlled Trial (RCT) study design, PNPLA3 risk allele carriers (CG/GG genotype) with NAFLD, will be assigned 2:1 to a tailored NAFLD-specific weight loss intervention compared to a wait-list control group.
详细描述
The Mexican-American population accounts for 64.3% of the U.S. Hispanic population and is the fastest growing Hispanic subgroup. Non-alcoholic fatty liver disease (NAFLD) is a chronic disease associated with obesity that is highest in the nation for Mexican-American men. NAFLD consists of a spectrum of conditions, ranging from fatty liver to cirrhosis and liver cancer. Lack of physical activity and sugar-sweetened beverage consumption are risk factors for NAFLD and are highly evident in the Mexican-American male population. Additionally, Mexican-American men are at increased risk of NAFLD and liver cancer if they are carriers of a version of a gene (PNPLA3) found to increase risk and severity of NAFLD. In the absence of prescription medications, weight loss due to changes in diet and physical activity is recommended for the prevention and treatment of NAFLD. Changes in lifestyle that result in >5% body weight loss have been shown to improve levels of liver fat and even reverse the condition. Despite the clear need to develop effective intervention strategies for Mexican-American men, no studies to date have explored the use of health risk assessment strategies, including genetic risk, to motivate behavior change to reduce the risk of NAFLD in Mexican-American men. Consequently, this will be the first weight loss intervention for Mexican-American men to incorporate genetic predisposition and lifestyle risk factors of NAFLD (e.g., dietary sugar consumption), as a strategy to improve engagement in weight loss and weight maintenance behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessments will be performed at 0, 6, and 12-months post-intervention. To minimize the potential for bias, outcome assessors will be blinded to treatment condition.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identify as a Mexican or Mexican-American man
- •18-64 years of age
- •BMI between 30 to 50.0 kg/m²
- •Have a CAP score ≥248 at screening
- •Be identified as PNPLA3 risk allele carriers (CG/GG genotype) at screening
- •Be able to provide informed consent
- •Speak, read, and write either English and/or Spanish.
排除标准
- •Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis, Chron's disease, celiac disease)
- •Been previously diagnosed with viral hepatitis, liver disease or liver cancer
- •Have a history of bariatric surgery
- •Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
- •Have current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
- •Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100 mmHg
- •Have an eating disorders that would contraindicate weight loss or physical activity
- •Report significant alcohol consumption (e.g., drinking ≥ 21 standard drinks/week, binge drinkers, or those with previous heavy alcohol consumption) identified by the Alcohol Use Disorders Identification Test
- •Currently treated for psychological issues (e.g., depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
- •Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
- •Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
- •Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs
- •Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments.
结局指标
主要结局
Intervention delivery time at 12-months
时间窗: 12-months
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.
Study Recruitment: Interest in Participation at Baseline
时间窗: Baseline
The number of Mexican-American men who express interest in participation.
Study Recruitment: Enrollment at Baseline
时间窗: Baseline
The number of Mexican-American men enrolled in the study.
Retention at 12-months
时间窗: 12-months
Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.
Self-monitoring of dietary intake at 6-months
时间窗: 6-months
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.
Self-monitoring of physical activity at 12-months
时间窗: 12-months
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.
Study Recruitment: Screened for Eligibility at Baseline
时间窗: Baseline
The number of Mexican-American men screened for eligibility.
Study Recruitment: Eligibility at Baseline
时间窗: Baseline
The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.
Retention at 6-months
时间窗: 6-months
Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled.
Attendance at weekly counseling sessions at 12-months
时间窗: 12-months
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.
Self-monitoring of dietary intake at 12-months
时间窗: 12-months
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.
Attendance at weekly counseling sessions at 6-months
时间窗: 6-months
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.
Self-weighing behaviors at 6-months
时间窗: 6-months
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.
Intervention delivery time at 6-months
时间窗: 6-months
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.
Self-monitoring of physical activity at 6-months
时间窗: 6-months
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.
Self-weighing behaviors at 12-months
时间窗: 12-months
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.
Treatment Satisfaction at 6-months: rating
时间窗: 6-months
Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 6-months.
Treatment Satisfaction at 12-months: rating
时间窗: 12-months
Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 12-months.
次要结局
- Change in waist circumference at 12-months(12-months)
- Change in liver steatosis at 6-months(6-months)
- Change in liver steatosis at 12-months(12-months)
- Change in aspartate aminotransferase (AST) at 6-months(6-months)
- Change in physical activity at 12-months(12-months)
- Change in alanine aminotransferase (ALT) at 6-months(6-months)
- Change in physical activity at 6-months(6-months)
- Change in dietary intake at 6-months(6-months)
- Change in body weight at 12-months(12-months)
- Change in body weight at 6-months(6-months)
- Change in waist circumference at 6-months(6-months)
- Change in liver fibrosis at 12-months(12-months)
- Change in alanine aminotransferase (ALT) at 12-months(12-months)
- Change in weight loss self-efficacy at 6-months: questionnaire(6-months)
- Change in liver fibrosis at 6-months(6-months)
- Change in aspartate aminotransferase (AST) at 12-months(12-months)
- Change in weight loss self-efficacy at 12-months: questionnaire(12-months)
- Change in dietary intake at 12-months(12-months)