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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Attendance at weekly counseling sessions at 12-months
Attendance at weekly counseling sessions at 6-months
Intervention delivery time at 12-months
+15 moreSecondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,555 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,320 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
260 Patients Enrolled for Non-alcoholic Fatty Liver Disease
David O Garcia, PhDPrincipal InvestigatorUniversity of Arizona, Mel & Enid Zuckerman College of Public Health
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medication that affects my body composition or have taken liver-damaging drugs.I have had weight loss surgery in the past.I have heart problems like failure, chest pain, or irregular heartbeat.Your blood pressure is too high even when you're at rest.I am between 18 and 64 years old.I have been diagnosed with viral hepatitis, liver disease, or liver cancer.I have no health issues that prevent me from following a weight or exercise plan.I have been treated for mental health issues or taken related medications in the past year.I am a Mexican or Mexican-American man.I can speak, read, and write in English or Spanish.I carry the PNPLA3 gene variant linked to liver disease.My BMI is between 30 and 50.I have a long-term gut condition like Crohn's or celiac disease.You have an eating disorder that would make it unsafe to lose weight or engage in physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Wait-list control
- Group 2: NAFLD-specific weight loss intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over the age of seventy eligible to participate in this experiment?
"In accordance with this clinical trial's prerequisites, the approved age range for participation is 18 to 64 years of age."
Answered by AI
Who is the ideal patient population for this clinical experiment?
"Potential participants must have nonalcoholic steatohepatitis and be between 18-64 years old to qualify for this study. Currently, 39 patients are being enrolled."
Answered by AI
Is enrollment in this research endeavor still open?
"As per the information on clinicaltrials.gov, recruitment for this particular trial has closed. It was originally posted in February of 2023 and last edited October 7th 2022, however there are still 227 other studies that are presently open to new participants."
Answered by AI
What is the primary aim of this clinical experiment?
"The primary metric of this trial, monitored over a 6 month period, is patient eligibility at the beginning. Secondary objectives include tracking participants' body weight (measured via digital scale) and their confidence in managing their own weight loss (assessed through a 10-point Likert Scale questionnaire). These markers will be observed both after half a year and a full year from commencement of the study."
Answered by AI
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