NAFLDNCT04186260
A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
A study testing NAFLD-specific weight loss intervention in people with NAFLD, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- NAFLD-specific weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
Tucson, Arizona, 85714
About this study
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.
Read the 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.
- Conditions
- NAFLD
- Being tested
- NAFLD-specific weight loss intervention, Wait-list control
- Keywords
- obesity, overweight, Mexican, Mexican-American, men, weight loss
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Overweight, Multiple Endocrine Neoplasia Type 1, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFLD-specific weight loss interventionBehavioural
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.
Wait-list controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment: Interest in Participation at Baseline
The number of Mexican-American men who express interest in participation.
Measured: Baseline
Study Recruitment: Screened for Eligibility at Baseline
The number of Mexican-American men screened for eligibility.
Measured: Baseline
Study Recruitment: Eligibility at Baseline
The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.
Measured: Baseline
Study Recruitment: Enrollment at Baseline
The number of Mexican-American men enrolled in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months
Secondary outcomes (18)
Change in body weight at 6-months
Body weight (kg) will be measured on a digital scale to assess change in body weight at 6-months over the intervention period.
Measured: 6-months
Change in body weight at 12-months
Body weight (kg) will be measured on a digital scale to assess change in body weight at 12-months over the intervention period.
Measured: 12-months
Change in waist circumference at 6-months
Waist circumference (cm) will be assessed using a standardized protocol at 6-months.
Measured: 6-months
Change in waist circumference at 12-months
Waist circumference (cm) will be assessed using a standardized protocol at 12-months.
Measured: 12-months
Change in liver steatosis at 6-months
A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 6-months based on controlled attenuation parameters (CAP).
Measured: 6-months
Change in liver steatosis at 12-months
A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 12-months based on controlled attenuation parameters (CAP).
Measured: 12-months
Change in liver fibrosis at 6-months
A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 6-months based on kilopascals (kPa).
Measured: 6-months
Change in liver fibrosis at 12-months
A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 12-months based on kilopascals (kPa).
Measured: 12-months
Change in alanine aminotransferase (ALT) at 6-months
Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 6-months.
Measured: 6-months
Change in alanine aminotransferase (ALT) at 12-months
Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 12-months.
Measured: 12-months
Change in aspartate aminotransferase (AST) at 6-months
Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 6-months.
Measured: 6-months
Change in aspartate aminotransferase (AST) at 12-months
Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 12-months.
Measured: 12-months
Change in physical activity at 6-months
An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 6-months.
Measured: 6-months
Change in physical activity at 12-months
An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 12-months.
Measured: 12-months
Change in dietary intake at 6-months
24-hr recalls will be used to assess self reported food intake (kcal/day) at 6-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Measured: 6-months
Change in dietary intake at 12-months
24-hr recalls will be used to assess self reported food intake (kcal/day) at 12-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Measured: 12-months
Change in weight loss self-efficacy at 6-months: questionnaire
Change in weight loss self-efficacy at 6-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)).
Measured: 6-months
Change in weight loss self-efficacy at 12-months: questionnaire
Change in weight loss self-efficacy at 12-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)).
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Feb 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- David O Garcia, PhD, Principal investigator, University of Arizona, Mel & Enid Zuckerman College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186260
- Sponsor's protocol ID
- 1911187047
- Other IDs
- KMD014761A
- Status last verified
- Aug 2025
- First submitted
- 27 Nov 2019
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be stripped of identifiers prior to release for sharing. 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. The final dataset, including all study variables, will be developed for import into standard statistical software programs including SPSS, SASS and STATA.
Publications
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.
PubMed 25218670Lazo 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.
PubMed 26468154Saab 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.
PubMed 25976180Romeo 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.
PubMed 18820647Severson 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.
PubMed 27547017Tilg H, Moschen A. Weight loss: cornerstone in the treatment of non-alcoholic fatty liver disease. Minerva Gastroenterol Dietol. 2010 Jun;56(2):159-67.
PubMed 20485253Martinez 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.
PubMed 29055919Chalasani 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.
PubMed 28714183Jensen 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.
PubMed 24239920Musso 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.
PubMed 22278337
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
- ClinicalTrials.gov ID
- NCT04186260
- Acronym / sponsor ID
- 1911187047
- Conditions
- NAFLD
- Keywords
- obesity, overweight, Mexican, Mexican-American, men, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NAFLD-specific weight loss intervention | Experimental | Behavioral: NAFLD-specific weight loss interventionParticipants 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. |
| Wait-list control | Other | Other: Wait-list controlThe wait-list control group will receive the same intervention strategies described for the NAFLD-specific weight loss intervention after study comparisons have been made. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAFLD-specific weight loss interventionThis 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. | Behavioural | NAFLD-specific weight loss intervention |
| Wait-list controlParticipants 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. | Other | Wait-list control |
Primary outcome
Study Recruitment: Interest in Participation at Baseline
Time frame: Baseline
The number of Mexican-American men who express interest in participation.
Study Recruitment: Screened for Eligibility at Baseline
Time frame: Baseline
The number of Mexican-American men screened for eligibility.
Study Recruitment: Eligibility at Baseline
Time frame: Baseline
The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.
Study Recruitment: Enrollment at Baseline
Time frame: Baseline
The number of Mexican-American men enrolled in the study.
Retention at 6-months
Time frame: 6-months
Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled.
Retention at 12-months
Time frame: 12-months
Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.
Attendance at weekly counseling sessions at 6-months
Time frame: 6-months
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.
Attendance at weekly counseling sessions at 12-months
Time frame: 12-months
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.
Self-monitoring of dietary intake at 6-months
Time frame: 6-months
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.
Self-monitoring of dietary intake at 12-months
Time frame: 12-months
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.
Self-monitoring of physical activity at 6-months
Time frame: 6-months
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.
Self-monitoring of physical activity at 12-months
Time frame: 12-months
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.
Self-weighing behaviors at 6-months
Time frame: 6-months
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.
Self-weighing behaviors at 12-months
Time frame: 12-months
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.
Intervention delivery time at 6-months
Time frame: 6-months
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.
Intervention delivery time at 12-months
Time frame: 12-months
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.
Treatment Satisfaction at 6-months: rating
Time frame: 6-months
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.
Treatment Satisfaction at 12-months: rating
Time frame: 12-months
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.
18 secondary outcomes
Change in body weight at 6-months
Time frame: 6-months
Change in body weight at 12-months
Time frame: 12-months
Change in waist circumference at 6-months
Time frame: 6-months
Change in waist circumference at 12-months
Time frame: 12-months
Change in liver steatosis at 6-months
Time frame: 6-months
Change in liver steatosis at 12-months
Time frame: 12-months
Change in liver fibrosis at 6-months
Time frame: 6-months
Change in liver fibrosis at 12-months
Time frame: 12-months
Change in alanine aminotransferase (ALT) at 6-months
Time frame: 6-months
Change in alanine aminotransferase (ALT) at 12-months
Time frame: 12-months
Change in aspartate aminotransferase (AST) at 6-months
Time frame: 6-months
Change in aspartate aminotransferase (AST) at 12-months
Time frame: 12-months
Change in physical activity at 6-months
Time frame: 6-months
Change in physical activity at 12-months
Time frame: 12-months
Change in dietary intake at 6-months
Time frame: 6-months
Change in dietary intake at 12-months
Time frame: 12-months
Change in weight loss self-efficacy at 6-months: questionnaire
Time frame: 6-months
Change in weight loss self-efficacy at 12-months: questionnaire
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 25218670Kallwitz 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.
- Background: PubMed 26468154Lazo 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.
- Background: PubMed 25976180Saab 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.
- Background: PubMed 18820647Romeo 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.
- Background: PubMed 27547017Severson 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.
- Background: PubMed 20485253Tilg H, Moschen A. Weight loss: cornerstone in the treatment of non-alcoholic fatty liver disease. Minerva Gastroenterol Dietol. 2010 Jun;56(2):159-67.
- Background: PubMed 29055919Martinez 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.
- Background: PubMed 28714183Chalasani 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.
- Background: PubMed 24239920Jensen 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.
- Background: PubMed 22278337Musso 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.
- Individual participant dataSharing planned: Yes. The final dataset will be stripped of identifiers prior to release for sharing. 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. The final dataset, including all study variables, will be developed for import into standard statistical software programs including SPSS, SASS and STATA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David O Garcia, PhD principal investigator
University of Arizona, Mel & Enid Zuckerman College of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAFLD-specific weight loss intervention in people with NAFLD, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Recruitment: Interest in Participation at Baseline (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186260, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.