A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NAFLD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The pilot study uses a small randomized-controlled trial (RCT) design that will be conducted in two phases. The first phase includes recruitment, screening, and baseline assessment procedures. The second phase will include PNPLA3 risk allele carriers (CG/GG genotype) with NAFLD, who will be assigned 2:1 to a NAFLD-specific weight loss intervention tailored for Mexican-American men, including informing them of their lifestyle and genetic risk, for 12-months compared to a wait-list control group.Masking: Single (Outcomes Assessor)Masking Description: Assessments will be performed at 0, 6, and 12-months post-intervention. To minimize the potential for bias, outcome assessors will be blinded to treatment condition.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04186260
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Investigators
- Principal Investigator: David O Garcia, PhD University of Arizona, Mel & Enid Zuckerman College of Public Health
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