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

Description

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.

Conditions

NAFLD

Study Overview

Study Details

Study overview

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.

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

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

Condition
NAFLD
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment, Tucson, Arizona, United States, 85714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

18 Years to 64 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Arizona,

David O Garcia, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona, Mel & Enid Zuckerman College of Public Health

Study Record Dates

2025-12-29