A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
NAFLD
About this trial
This is an interventional treatment trial for NAFLD focused on measuring obesity, overweight, Mexican, Mexican-American, men, weight loss
Eligibility Criteria
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.
Sites / Locations
- University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
Arms of the Study
Arm 1
Arm 2
Experimental
Other
NAFLD-specific weight loss intervention
Wait-list control
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.
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.