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

NCT04186260 | Completed

• 2 other identifiers: 1911187047KMD014761A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Keywords

obesity; overweight; Mexican; Mexican-American; men; weight loss

Outcome Measures

Primary Outcomes (18)

• Study Recruitment: Interest in Participation at Baseline

  The number of Mexican-American men who express interest in participation.

  Baseline

• Study Recruitment: Screened for Eligibility at Baseline

  The number of Mexican-American men screened for eligibility.

  Baseline

• Study Recruitment: Eligibility at Baseline

  The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.

  Baseline

• Study Recruitment: Enrollment at Baseline

  The number of Mexican-American men enrolled in the study.

  Baseline

• Retention at 6-months

  Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled.

  6-months

• Retention at 12-months

  Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.

  12-months

• Attendance at weekly counseling sessions at 6-months

  The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.

  6-months

• Attendance at weekly counseling sessions at 12-months

  The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.

  12-months

• Self-monitoring of dietary intake at 6-months

  The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.

  6-months

• Self-monitoring of dietary intake at 12-months

  The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.

  12-months

• Self-monitoring of physical activity at 6-months

  The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.

  6-months

• Self-monitoring of physical activity at 12-months

  The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.

  12-months

• Self-weighing behaviors at 6-months

  The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.

  6-months

• Self-weighing behaviors at 12-months

  The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.

  12-months

• Intervention delivery time at 6-months

  The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.

  6-months

• Intervention delivery time at 12-months

  The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.

  12-months

• Treatment Satisfaction at 6-months: rating

  Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 6-months.

  6-months

• Treatment Satisfaction at 12-months: rating

  Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 12-months.

  12-months

Secondary Outcomes (18)

• Change in body weight at 6-months

  6-months

• Change in body weight at 12-months

  12-months

• Change in waist circumference at 6-months

  6-months

• Change in waist circumference at 12-months

  12-months

• Change in liver steatosis at 6-months

  6-months

Study Arms (2)

NAFLD-specific weight loss intervention

EXPERIMENTAL

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.

Behavioral: NAFLD-specific weight loss intervention

Wait-list control

OTHER

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.

Other: Wait-list control

Interventions

NAFLD-specific weight loss intervention BEHAVIORAL

This is a 12-month NAFLD-specific weight loss intervention that is explicitly tailored for Mexican-American men. It will include recommendations for diet, physical activity, and will utilize risk for NAFLD as a mechanism to engage men in lifestyle modification.

NAFLD-specific weight loss intervention

Wait-list control OTHER

Participants in this condition will not receive treatment for 12-months until study comparisons have been made. After 12-months, participants will receive the 12-month NAFLD-specific weight loss intervention.

Wait-list control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-identify as a Mexican or Mexican-American man
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Tucson, Arizona, 85714, United States

Location

Related Publications (10)

• Kallwitz ER, Daviglus ML, Allison MA, Emory KT, Zhao L, Kuniholm MH, Chen J, Gouskova N, Pirzada A, Talavera GA, Youngblood ME, Cotler SJ. Prevalence of suspected nonalcoholic fatty liver disease in Hispanic/Latino individuals differs by heritage. Clin Gastroenterol Hepatol. 2015 Mar;13(3):569-76. doi: 10.1016/j.cgh.2014.08.037. Epub 2014 Sep 15.

  PMID: 25218670 BACKGROUND

• Lazo M, Bilal U, Perez-Escamilla R. Epidemiology of NAFLD and Type 2 Diabetes: Health Disparities Among Persons of Hispanic Origin. Curr Diab Rep. 2015 Dec;15(12):116. doi: 10.1007/s11892-015-0674-6.

  PMID: 26468154 BACKGROUND

• Saab S, Manne V, Nieto J, Schwimmer JB, Chalasani NP. Nonalcoholic Fatty Liver Disease in Latinos. Clin Gastroenterol Hepatol. 2016 Jan;14(1):5-12; quiz e9-10. doi: 10.1016/j.cgh.2015.05.001. Epub 2015 May 11.

  PMID: 25976180 BACKGROUND

• Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.

  PMID: 18820647 BACKGROUND

• Severson TJ, Besur S, Bonkovsky HL. Genetic factors that affect nonalcoholic fatty liver disease: A systematic clinical review. World J Gastroenterol. 2016 Aug 7;22(29):6742-56. doi: 10.3748/wjg.v22.i29.6742.

  PMID: 27547017 BACKGROUND

• Tilg H, Moschen A. Weight loss: cornerstone in the treatment of non-alcoholic fatty liver disease. Minerva Gastroenterol Dietol. 2010 Jun;56(2):159-67.

  PMID: 20485253 BACKGROUND

• Martinez LA, Larrieta E, Kershenobich D, Torre A. The Expression of PNPLA3 Polymorphism could be the Key for Severe Liver Disease in NAFLD in Hispanic Population. Ann Hepatol. 2017 November-December,;16(6):909-915. doi: 10.5604/01.3001.0010.5282.

  PMID: 29055919 BACKGROUND

• Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

  PMID: 28714183 BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.

  PMID: 24239920 BACKGROUND

• Musso G, Cassader M, Rosina F, Gambino R. Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials. Diabetologia. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-011-2446-4. Epub 2012 Jan 27.

  PMID: 22278337 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Overweight; Multiple Endocrine Neoplasia Type 1; Weight Loss

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Body Weight Changes

Study Officials

• David O Garcia, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be performed at 0, 6, and 12-months post-intervention. To minimize the potential for bias, outcome assessors will be blinded to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 4, 2019
• Study Start: February 5, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The final dataset will be cleaned and organized during the final study year and will be available only to the study PI or designees (Co-Investigators, Collaborators) for 36-months post-study completion. At that time the dataset then will be made more widely available through data use agreements with the PI/University of Arizona. Access will require registration including investigator name, credentials, and academic affiliation.
• Access Criteria: Dr. Garcia will make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All study data collection forms will be made available as pdf files; data collection time-points and dictionary of data definitions also will be made available.

Locations

US (1)