NCT04186260

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• NAFLD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2019-12-04
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States