COMPLETED

A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

Conditions

NAFLD obesity overweight Mexican Mexican-American men weight loss

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

Quick Facts

Study Start:2024-02-05

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04186260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Self-identify as a Mexican or Mexican-American man * 18-64 years of age * BMI between 30 to 50.0 kg/m² * Have a CAP score ≥248 at screening * Be identified as PNPLA3 risk allele carriers (CG/GG genotype) at screening * Be able to provide informed consent * Speak, read, and write either English and/or Spanish.	* Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis, Chron's disease, celiac disease) * Been previously diagnosed with viral hepatitis, liver disease or liver cancer * Have a history of bariatric surgery * Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study * Have current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event * Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100 mmHg * Have an eating disorders that would contraindicate weight loss or physical activity * Report significant alcohol consumption (e.g., drinking ≥ 21 standard drinks/week, binge drinkers, or those with previous heavy alcohol consumption) identified by the Alcohol Use Disorders Identification Test * Currently treated for psychological issues (e.g., depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years * Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months * Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months * Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs * Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments.

Inclusion Criteria

Exclusion Criteria

* Self-identify as a Mexican or Mexican-American man
* 18-64 years of age
* BMI between 30 to 50.0 kg/m²
* Have a CAP score ≥248 at screening
* Be identified as PNPLA3 risk allele carriers (CG/GG genotype) at screening
* Be able to provide informed consent
* Speak, read, and write either English and/or Spanish.

* Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis, Chron's disease, celiac disease)
* Been previously diagnosed with viral hepatitis, liver disease or liver cancer
* Have a history of bariatric surgery
* Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
* Have current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
* Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100 mmHg
* Have an eating disorders that would contraindicate weight loss or physical activity
* Report significant alcohol consumption (e.g., drinking ≥ 21 standard drinks/week, binge drinkers, or those with previous heavy alcohol consumption) identified by the Alcohol Use Disorders Identification Test
* Currently treated for psychological issues (e.g., depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
* Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
* Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
* Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs
* Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments.

Contacts and Locations

Principal Investigator

David O Garcia, PhD

PRINCIPAL_INVESTIGATOR

University of Arizona, Mel & Enid Zuckerman College of Public Health

Study Locations (Sites)

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Tucson, Arizona, 85714

United States

Collaborators and Investigators

Sponsor: University of Arizona

David O Garcia, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona, Mel & Enid Zuckerman College of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

obesity
overweight
Mexican
Mexican-American
men
weight loss

Additional Relevant MeSH Terms

NAFLD