Weight Loss Intervention for Non-alcoholic Fatty Liver Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants not take any medication or supplement known to affect body composition or have a history of exposure to drugs that can harm the liver. If your current medications fall into these categories, you may need to stop taking them.
What data supports the effectiveness of the treatment for weight loss intervention in non-alcoholic fatty liver disease?
Is the weight loss intervention for NAFLD safe for humans?
How is the NAFLD-specific weight loss intervention different from other treatments for non-alcoholic fatty liver disease?
The NAFLD-specific weight loss intervention is unique because it focuses on a combined lifestyle approach, involving dietary changes and physical activity, tailored specifically for NAFLD patients. Unlike other treatments, this intervention is guided by a multidisciplinary team to optimize weight loss and improve liver health.1391011
What is the purpose of this trial?
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.
Research Team
David O Garcia, PhD
Principal Investigator
University of Arizona, Mel & Enid Zuckerman College of Public Health
Eligibility Criteria
Mexican or Mexican-American men aged 18-64 with Non-alcoholic Fatty Liver Disease (NAFLD) and a specific genetic risk (PNPLA3 CG/GG genotype). Participants must have a BMI of 30 to 50, speak English or Spanish, and be able to consent. Excluded are those who exercise regularly, recently lost weight or plan significant travel; also excluded are individuals with certain medical conditions like viral hepatitis, heavy alcohol use, psychological issues under recent treatment, cardiovascular risks, uncontrolled high blood pressure, gastrointestinal disorders or eating disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a tailored NAFLD-specific weight loss intervention, including 12 weekly individual counseling sessions and self-monitoring of body weight, eating, and physical activity behaviors.
Follow-up
Participants complete a 12-week follow-up including bi-weekly phone calls, followed by a 6-month follow-up period with no intervention contact.
Treatment Details
Interventions
- NAFLD-specific weight loss intervention
- Wait-list control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator