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Completed

NCT Number: NCT04186260

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

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.

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Key information

Conditions

NAFLD Body Weight Body Weight Changes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fatty Liver Genetic Diseases, Inborn Liver Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Tucson, Arizona, 85714, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAFLD-specific weight loss intervention

Behavioral

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.

Wait-list control

Other

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.

Primary outcomes

  1. Study Recruitment: Interest in Participation at Baseline

    Time frame: Baseline

    The number of Mexican-American men who express interest in participation.

  2. Study Recruitment: Screened for Eligibility at Baseline

    Time frame: Baseline

    The number of Mexican-American men screened for eligibility.

  3. Study Recruitment: Eligibility at Baseline

    Time frame: Baseline

    The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.

  4. Study Recruitment: Enrollment at Baseline

    Time frame: Baseline

    The number of Mexican-American men enrolled in the study.

  5. Retention at 6-months

    Time frame: 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. Retention at 12-months

    Time frame: 12-months

    Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.

  7. Attendance at weekly counseling sessions at 6-months

    Time frame: 6-months

    The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.

  8. Attendance at weekly counseling sessions at 12-months

    Time frame: 12-months

    The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.

  9. Self-monitoring of dietary intake at 6-months

    Time frame: 6-months

    The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.

  10. Self-monitoring of dietary intake at 12-months

    Time frame: 12-months

    The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.

  11. Self-monitoring of physical activity at 6-months

    Time frame: 6-months

    The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.

  12. Self-monitoring of physical activity at 12-months

    Time frame: 12-months

    The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.

  13. Self-weighing behaviors at 6-months

    Time frame: 6-months

    The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.

  14. Self-weighing behaviors at 12-months

    Time frame: 12-months

    The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.

  15. Intervention delivery time at 6-months

    Time frame: 6-months

    The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.

  16. Intervention delivery time at 12-months

    Time frame: 12-months

    The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.

  17. Treatment Satisfaction at 6-months: rating

    Time frame: 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.

  18. Treatment Satisfaction at 12-months: rating

    Time frame: 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.

Secondary outcomes

  1. Change in body weight at 6-months

    Time frame: 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.

  2. Change in body weight at 12-months

    Time frame: 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.

  3. Change in waist circumference at 6-months

    Time frame: 6-months

    Waist circumference (cm) will be assessed using a standardized protocol at 6-months.

  4. Change in waist circumference at 12-months

    Time frame: 12-months

    Waist circumference (cm) will be assessed using a standardized protocol at 12-months.

  5. Change in liver steatosis at 6-months

    Time frame: 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. Change in liver steatosis at 12-months

    Time frame: 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).

  7. Change in liver fibrosis at 6-months

    Time frame: 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).

  8. Change in liver fibrosis at 12-months

    Time frame: 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).

  9. Change in alanine aminotransferase (ALT) at 6-months

    Time frame: 6-months

    Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 6-months.

  10. Change in alanine aminotransferase (ALT) at 12-months

    Time frame: 12-months

    Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 12-months.

  11. Change in aspartate aminotransferase (AST) at 6-months

    Time frame: 6-months

    Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 6-months.

  12. Change in aspartate aminotransferase (AST) at 12-months

    Time frame: 12-months

    Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 12-months.

  13. Change in physical activity at 6-months

    Time frame: 6-months

    An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 6-months.

  14. Change in physical activity at 12-months

    Time frame: 12-months

    An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 12-months.

  15. Change in dietary intake at 6-months

    Time frame: 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.

  16. Change in dietary intake at 12-months

    Time frame: 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.

  17. Change in weight loss self-efficacy at 6-months: questionnaire

    Time frame: 6-months

    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)).

  18. Change in weight loss self-efficacy at 12-months: questionnaire

    Time frame: 12-months

    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)).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2019
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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