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Weight Loss Intervention for Non-alcoholic Fatty Liver Disease

N/A

Recruiting

Led By David O Garcia, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-64 years of age

Self-identify as a Mexican or Mexican-American man

Must not have

Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs

Have a history of bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a weight loss intervention specifically for people with NAFLD and the PNPLA3 risk allele will be more effective than no intervention.

Who is the study for?

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.

What is being tested?

The trial is testing a NAFLD-specific weight loss intervention tailored for the participants' cultural background against a wait-list control group. Using an RCT design where two-thirds receive the intervention and one-third waits for later treatment allows comparison of outcomes between active and delayed interventions.

What are the potential side effects?

Since this is a lifestyle intervention focusing on weight loss rather than medication or surgery, side effects may include typical responses to diet changes such as digestive discomfort. However detailed side effects aren't provided here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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I am a Mexican or Mexican-American man.

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I carry the PNPLA3 gene variant linked to liver disease.

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My BMI is between 30 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medication that affects my body composition or have taken liver-damaging drugs.

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I have had weight loss surgery in the past.

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I have heart problems like failure, chest pain, or irregular heartbeat.

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I have been diagnosed with viral hepatitis, liver disease, or liver cancer.

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I have a long-term gut condition like Crohn's or celiac disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attendance at weekly counseling sessions at 12-months

Attendance at weekly counseling sessions at 6-months

Intervention delivery time at 12-months

+15 more

Secondary study objectives

Change in alanine aminotransferase (ALT) at 12-months

Change in alanine aminotransferase (ALT) at 6-months

Change in aspartate aminotransferase (AST) at 12-months

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Wait-list controlExperimental Treatment1 Intervention

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.

Group II: NAFLD-specific weight loss interventionExperimental Treatment1 Intervention

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.

0 / 9Eligibility criteria met