NAFLD-specific weight loss intervention for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nonalcoholic Steatohepatitis+1 More
NAFLD-specific weight loss intervention - Behavioral
Eligibility
18 - 65
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Nonalcoholic Steatohepatitis
  • (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

18 Primary · 18 Secondary · Reporting Duration: 12-months

12-months
Attendance at weekly counseling sessions at 12-months
Change in alanine aminotransferase (ALT) at 12-months
Change in aspartate aminotransferase (AST) at 12-months
Change in body weight at 12-months
Change in dietary intake at 12-months
Change in liver fibrosis at 12-months
Change in liver steatosis at 12-months
Change in physical activity at 12-months
Change in waist circumference at 12-months
Change in weight loss self-efficacy at 12-months: questionnaire
Intervention delivery time at 12-months
Retention at 12-months
Self-monitoring of dietary intake at 12-months
Self-monitoring of physical activity at 12-months
Self-weighing behaviors at 12-months
Treatment Satisfaction at 12-months: rating
6-months
Attendance at weekly counseling sessions at 6-months
Change in alanine aminotransferase (ALT) at 6-months
Change in aspartate aminotransferase (AST) at 6-months
Change in body weight at 6-months
Change in dietary intake at 6-months
Change in liver fibrosis at 6-months
Change in liver steatosis at 6-months
Change in physical activity at 6-months
Change in waist circumference at 6-months
Change in weight loss self-efficacy at 6-months: questionnaire
Intervention delivery time at 6-months
Retention at 6-months
Self-monitoring of dietary intake at 6-months
Self-monitoring of physical activity at 6-months
Self-weighing behaviors at 6-months
Treatment Satisfaction at 6-months: rating
Baseline
Study Recruitment: Eligibility at Baseline
Study Recruitment: Enrollment at Baseline
Study Recruitment: Interest in Participation at Baseline
Study Recruitment: Screened for Eligibility at Baseline

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

NAFLD-specific weight loss intervention
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: NAFLD-specific weight loss intervention · No Placebo Group · N/A

NAFLD-specific weight loss intervention
Behavioral
Experimental Group · 1 Intervention: NAFLD-specific weight loss intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-months

Who is running the clinical trial?

University of ArizonaLead Sponsor
456 Previous Clinical Trials
156,115 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
280 Previous Clinical Trials
702,245 Total Patients Enrolled
David O Garcia, PhDPrincipal InvestigatorUniversity of Arizona, Mel & Enid Zuckerman College of Public Health
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You self-identify as a Mexican or Mexican-American man.
You are a carrier of the PNPLA3 risk allele.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References