Clinical trial NCT04186260: A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
Official title: A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Keywords: obesity
overweight
Mexican
Mexican-American
men
weight loss
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-12-04
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pilot study uses a small randomized-controlled trial (RCT) design that will be conducted in two phases. The first phase includes recruitment, screening, and baseline assessment procedures. The second phase will include PNPLA3 risk allele carriers (CG/GG genotype) with NAFLD, who will be assigned 2:1 to a NAFLD-specific weight loss intervention tailored for Mexican-American men, including informing them of their lifestyle and genetic risk, for 12-months compared to a wait-list control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The Mexican-American population accounts for 64.3% of the U.S. Hispanic population and is the fastest growing Hispanic subgroup. Non-alcoholic fatty liver disease (NAFLD) is a chronic disease associated with obesity that is highest in the nation for Mexican-American men. NAFLD consists of a spectrum of conditions, ranging from fatty liver to cirrhosis and liver cancer. Lack of physical activity and sugar-sweetened beverage consumption are risk factors for NAFLD and are highly evident in the Mexican-American male population. Additionally, Mexican-American men are at increased risk of NAFLD and liver cancer if they are carriers of a version of a gene (PNPLA3) found to increase risk and severity of NAFLD. In the absence of prescription medications, weight loss due to changes in diet and physical activity is recommended for the prevention and treatment of NAFLD. Changes in lifestyle that result in \>5% body weight loss have been shown to improve levels of liver fat and even reverse the condition. Despite the clear need to develop effective intervention strategies for Mexican-American men, no studies to date have explored the use of health risk assessment strategies, including genetic risk, to motivate behavior change to reduce the risk of NAFLD in Mexican-American men. Consequently, this will be the first weight loss intervention for Mexican-American men to incorporate genetic predisposition and lifestyle risk factors of NAFLD (e.g., dietary sugar consumption), as a strategy to improve engagement in weight loss and weight maintenance behaviors.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Study Recruitment: Interest in Participation at Baseline
timeFrame: Baseline
measure: Study Recruitment: Screened for Eligibility at Baseline
timeFrame: Baseline
measure: Study Recruitment: Eligibility at Baseline
timeFrame: Baseline
measure: Study Recruitment: Enrollment at Baseline
timeFrame: Baseline
measure: Retention at 6-months
timeFrame: 6-months
measure: Retention at 12-months
timeFrame: 12-months
measure: Attendance at weekly counseling sessions at 6-months
timeFrame: 6-months
measure: Attendance at weekly counseling sessions at 12-months
timeFrame: 12-months
measure: Self-monitoring of dietary intake at 6-months
timeFrame: 6-months
measure: Self-monitoring of dietary intake at 12-months
timeFrame: 12-months
measure: Self-monitoring of physical activity at 6-months
timeFrame: 6-months
measure: Self-monitoring of physical activity at 12-months
timeFrame: 12-months
measure: Self-weighing behaviors at 6-months
timeFrame: 6-months
measure: Self-weighing behaviors at 12-months
timeFrame: 12-months
measure: Intervention delivery time at 6-months
timeFrame: 6-months
measure: Intervention delivery time at 12-months
timeFrame: 12-months
measure: Treatment Satisfaction at 6-months: rating
timeFrame: 6-months
measure: Treatment Satisfaction at 12-months: rating
timeFrame: 12-months
Secondary outcomes:
measure: Change in body weight at 6-months
timeFrame: 6-months
measure: Change in body weight at 12-months
timeFrame: 12-months
measure: Change in waist circumference at 6-months
timeFrame: 6-months
measure: Change in waist circumference at 12-months
timeFrame: 12-months
measure: Change in liver steatosis at 6-months
timeFrame: 6-months
measure: Change in liver steatosis at 12-months
timeFrame: 12-months
measure: Change in liver fibrosis at 6-months
timeFrame: 6-months
measure: Change in liver fibrosis at 12-months
timeFrame: 12-months
measure: Change in alanine aminotransferase (ALT) at 6-months
timeFrame: 6-months
measure: Change in alanine aminotransferase (ALT) at 12-months
timeFrame: 12-months
measure: Change in aspartate aminotransferase (AST) at 6-months
timeFrame: 6-months
measure: Change in aspartate aminotransferase (AST) at 12-months
timeFrame: 12-months
measure: Change in physical activity at 6-months
timeFrame: 6-months
measure: Change in physical activity at 12-months
timeFrame: 12-months
measure: Change in dietary intake at 6-months
timeFrame: 6-months
measure: Change in dietary intake at 12-months
timeFrame: 12-months
measure: Change in weight loss self-efficacy at 6-months: questionnaire
timeFrame: 6-months
measure: Change in weight loss self-efficacy at 12-months: questionnaire
timeFrame: 12-months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
state: Arizona
Study officials:
affiliation: University of Arizona, Mel & Enid Zuckerman College of Public Health
name: David O Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
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