A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: NAFLD-specific weight loss intervention
* Other: Wait-list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The pilot study uses a small randomized-controlled trial (RCT) design that will be conducted in two phases. The first phase includes recruitment, screening, and baseline assessment procedures. The second phase will include PNPLA3 risk allele carriers (CG/GG genotype) with NAFLD, who will be assigned 2:1 to a NAFLD-specific weight loss intervention tailored for Mexican-American men, including informing them of their lifestyle and genetic risk, for 12-months compared to a wait-list control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAFLD-specific weight loss intervention<br>Participants will attend 12 weekly 30-45-minute individual counseling sessions and receive tailored lesson materials focused on behavioral strategies for adopting and maintaining healthy eating and physical activity (PA) behaviors. Participants will self-monitor their body weight, eating, and PA behaviors in a weekly journal. Dietary recommendations will follow nutritional guidelines for the treatment of NAFLD. To facilitate the adoption of the dietary recommendation, participants will be provided culturally-tailored meal plans and grocery lists that allow them to make small, practical dietary changes of  100 calories. Participants will be prescribed weekly exercise goals with the duration increasing from 15-45 minutes, 5 days/week, over the 12-month program. After the completion of 12 weekly individual counseling sessions, participants will complete a 12-week follow-up including bi-weekly phone calls, followed by a 6-month follow-up period in which no intervention contact is made. | Behavioral: NAFLD-specific weight loss intervention<br>* This is a 12-month NAFLD-specific weight loss intervention that is explicitly tailored for Mexican-American men. It will include recommendations for diet, physical activity, and will utilize risk for NAFLD as a mechanism to engage men in lifestyle modification.<br>|
| Other: Wait-list control<br>The wait-list control group will receive the same intervention strategies described for the NAFLD-specific weight loss intervention after study comparisons have been made. | Other: Wait-list control<br>* Participants in this condition will not receive treatment for 12-months until study comparisons have been made. After 12-months, participants will receive the 12-month NAFLD-specific weight loss intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Recruitment: Interest in Participation at Baseline | The number of Mexican-American men who express interest in participation. | Baseline | 
| Study Recruitment: Screened for Eligibility at Baseline | The number of Mexican-American men screened for eligibility. | Baseline | 
| Study Recruitment: Eligibility at Baseline | The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility. | Baseline | 
| Study Recruitment: Enrollment at Baseline | The number of Mexican-American men enrolled in the study. | Baseline | 
| Retention at 6-months | Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled. | 6-months | 
| Retention at 12-months | Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled. | 12-months | 
| Attendance at weekly counseling sessions at 6-months | The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months. | 6-months | 
| Attendance at weekly counseling sessions at 12-months | The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months. | 12-months | 
| Self-monitoring of dietary intake at 6-months | The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months. | 6-months | 
| Self-monitoring of dietary intake at 12-months | The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months. | 12-months | 
| Self-monitoring of physical activity at 6-months | The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months. | 6-months | 
| Self-monitoring of physical activity at 12-months | The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months. | 12-months | 
| Self-weighing behaviors at 6-months | The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months. | 6-months | 
| Self-weighing behaviors at 12-months | The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months. | 12-months | 
| Intervention delivery time at 6-months | The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months. | 6-months | 
| Intervention delivery time at 12-months | The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months. | 12-months | 
| Treatment Satisfaction at 6-months: rating | 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. | 6-months | 
| Treatment Satisfaction at 12-months: rating | 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. | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight at 6-months | Body weight (kg) will be measured on a digital scale to assess change in body weight at 6-months over the intervention period. | 6-months | 
| Change in body weight at 12-months | Body weight (kg) will be measured on a digital scale to assess change in body weight at 12-months over the intervention period. | 12-months | 
| Change in waist circumference at 6-months | Waist circumference (cm) will be assessed using a standardized protocol at 6-months. | 6-months | 
| Change in waist circumference at 12-months | Waist circumference (cm) will be assessed using a standardized protocol at 12-months. | 12-months | 
| Change in liver steatosis at 6-months | A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 6-months based on controlled attenuation parameters (CAP). | 6-months | 
| Change in liver steatosis at 12-months | A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 12-months based on controlled attenuation parameters (CAP). | 12-months | 
| Change in liver fibrosis at 6-months | A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 6-months based on kilopascals (kPa). | 6-months | 
| Change in liver fibrosis at 12-months | A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 12-months based on kilopascals (kPa). | 12-months | 
| Change in alanine aminotransferase (ALT) at 6-months | Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 6-months. | 6-months | 
| Change in alanine aminotransferase (ALT) at 12-months | Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 12-months. | 12-months | 
| Change in aspartate aminotransferase (AST) at 6-months | Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 6-months. | 6-months | 
| Change in aspartate aminotransferase (AST) at 12-months | Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 12-months. | 12-months | 
| Change in physical activity at 6-months | An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 6-months. | 6-months | 
| Change in physical activity at 12-months | An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 12-months. | 12-months | 
| Change in dietary intake at 6-months | 24-hr recalls will be used to assess self reported food intake (kcal/day) at 6-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | 6-months | 
| Change in dietary intake at 12-months | 24-hr recalls will be used to assess self reported food intake (kcal/day) at 12-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | 12-months | 
| Change in weight loss self-efficacy at 6-months: questionnaire | Change in weight loss self-efficacy at 6-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)). | 6-months | 
| Change in weight loss self-efficacy at 12-months: questionnaire | Change in weight loss self-efficacy at 12-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)). | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, Mexican, Mexican-American, men, weight loss