39 Participants Needed

Weight Loss Intervention for Non-alcoholic Fatty Liver Disease

PS
Overseen ByPaul Sandoval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research shows that lifestyle changes, including weight loss, are effective in treating non-alcoholic fatty liver disease (NAFLD). Studies indicate that Mediterranean diets and behavioral interventions can help achieve significant weight loss, which is crucial for managing NAFLD.12345

Is the weight loss intervention for NAFLD safe for humans?

The studies reviewed focus on the effectiveness of weight loss interventions for NAFLD, but they do not provide specific safety data for these interventions. Generally, lifestyle changes like diet and exercise are considered safe for most people.12678

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

DO

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

I am a Mexican or Mexican-American man.
I can speak, read, and write in English or Spanish.
Have a CAP score ≥248 at screening
See 3 more

Exclusion 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.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks
12 visits (in-person)

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.

9 months
Bi-weekly phone calls for 12 weeks

Treatment Details

Interventions

  • NAFLD-specific weight loss intervention
  • Wait-list control
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Findings from Research

A 12-month multidisciplinary lifestyle intervention for patients with nonalcoholic fatty liver disease (NAFLD) resulted in significant weight loss, with 92.2% of participants maintaining a lower weight compared to baseline, compared to only 50% in the conventional treatment group.
Patients in the multidisciplinary treatment group experienced an average weight reduction of 4.2 kg and significant improvements in liver enzymes, highlighting the efficacy of a structured dietary plan over standard recommendations.
NAFLD Nutritional Management: Results from a Multidisciplinary Approach.Policarpo, SRO., Machado, MV., Barreira, D., et al.[2022]
A scoping review of 28 studies on behavioral weight-loss interventions for patients with NAFLD found that successful programs typically resulted in an average weight loss of at least 5% and included features like biweekly counseling and specific activity targets.
Retention rates were highest for telephone-based interventions, while face-to-face programs had lower retention, particularly among younger women and those with multiple metabolic conditions, indicating a need for tailored approaches to improve adherence.
Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review.Balakrishnan, M., Liu, K., Schmitt, S., et al.[2023]
A 12-week study involving 88 Chinese females with nonalcoholic fatty liver disease (NAFLD) showed that a Mediterranean-like diet led to significant weight loss and reductions in liver fat content, with the diet group losing an average of 4.0 kg compared to only 1.5 kg in the control group.
Supplementation with pentadecanoic acid (C15:0) further improved health outcomes by lowering LDL-cholesterol and positively affecting gut microbiome composition, indicating that this dietary approach can enhance metabolic health in individuals with NAFLD.
Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial.Chooi, YC., Zhang, QA., Magkos, F., et al.[2023]

References

NAFLD Nutritional Management: Results from a Multidisciplinary Approach. [2022]
Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review. [2023]
Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial. [2023]
Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. [2022]
Effect of intensive weight-loss intervention on metabolic, ultrasound and anthropometric parameters among patients with obesity and non-alcoholic fatty liver disease: an RCT. [2022]
Weight loss, dietary advice and statin therapy in non-alcoholic fatty liver disease: a retrospective study. [2014]
Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. [2022]
The Effect of a Lifestyle Modification Education on Adiposity Measures in Overweight and Obese Nonalcoholic Fatty Liver Disease Patients. [2022]
Evaluation of Dietary Approaches for the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review. [2020]
Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. [2022]
Lifestyle interventions for the treatment of non-alcoholic fatty liver disease. [2021]
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