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

NCT04186260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-24

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

NAFLD-specific weight loss intervention

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.

OTHER

Wait-list control

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04186260 on ClinicalTrials.gov