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

Primary Purpose

NAFLD

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NAFLD-specific weight loss intervention
Wait-list control
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring obesity, overweight, Mexican, Mexican-American, men, weight loss

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NAFLD-specific weight loss intervention

Wait-list control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Study Recruitment: Interest in Participation at Baseline
The number of Mexican-American men who express interest in participation.
Study Recruitment: Screened for Eligibility at Baseline
The number of Mexican-American men screened for eligibility.
Study Recruitment: Eligibility at Baseline
The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.
Study Recruitment: Enrollment at Baseline
The number of Mexican-American men enrolled in the study.
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.
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.
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.
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.
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.
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.
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.
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.
Self-weighing behaviors at 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
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 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.
Intervention delivery time at 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
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
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.

Secondary Outcome Measures

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.
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.
Change in waist circumference at 6-months
Waist circumference (cm) will be assessed using a standardized protocol at 6-months.
Change in waist circumference at 12-months
Waist circumference (cm) will be assessed using a standardized protocol at 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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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)).
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)).

Full Information

First Posted
November 27, 2019
Last Updated
October 5, 2023
Sponsor
University of Arizona
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04186260
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 6, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
Keywords
obesity, overweight, Mexican, Mexican-American, men, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAFLD-specific weight loss intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NAFLD-specific weight loss intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait-list control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study Recruitment: Interest in Participation at Baseline
Description
The number of Mexican-American men who express interest in participation.
Time Frame
Baseline
Title
Study Recruitment: Screened for Eligibility at Baseline
Description
The number of Mexican-American men screened for eligibility.
Time Frame
Baseline
Title
Study Recruitment: Eligibility at Baseline
Description
The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.
Time Frame
Baseline
Title
Study Recruitment: Enrollment at Baseline
Description
The number of Mexican-American men enrolled in the study.
Time Frame
Baseline
Title
Retention at 6-months
Description
Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled.
Time Frame
6-months
Title
Retention at 12-months
Description
Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.
Time Frame
12-months
Title
Attendance at weekly counseling sessions at 6-months
Description
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.
Time Frame
6-months
Title
Attendance at weekly counseling sessions at 12-months
Description
The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.
Time Frame
12-months
Title
Self-monitoring of dietary intake at 6-months
Description
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.
Time Frame
6-months
Title
Self-monitoring of dietary intake at 12-months
Description
The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.
Time Frame
12-months
Title
Self-monitoring of physical activity at 6-months
Description
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.
Time Frame
6-months
Title
Self-monitoring of physical activity at 12-months
Description
The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.
Time Frame
12-months
Title
Self-weighing behaviors at 6-months
Description
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.
Time Frame
6-months
Title
Self-weighing behaviors at 12-months
Description
The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.
Time Frame
12-months
Title
Intervention delivery time at 6-months
Description
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.
Time Frame
6-months
Title
Intervention delivery time at 12-months
Description
The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.
Time Frame
12-months
Title
Treatment Satisfaction at 6-months: rating
Description
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.
Time Frame
6-months
Title
Treatment Satisfaction at 12-months: rating
Description
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.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Change in body weight at 6-months
Description
Body weight (kg) will be measured on a digital scale to assess change in body weight at 6-months over the intervention period.
Time Frame
6-months
Title
Change in body weight at 12-months
Description
Body weight (kg) will be measured on a digital scale to assess change in body weight at 12-months over the intervention period.
Time Frame
12-months
Title
Change in waist circumference at 6-months
Description
Waist circumference (cm) will be assessed using a standardized protocol at 6-months.
Time Frame
6-months
Title
Change in waist circumference at 12-months
Description
Waist circumference (cm) will be assessed using a standardized protocol at 12-months.
Time Frame
12-months
Title
Change in liver steatosis at 6-months
Description
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).
Time Frame
6-months
Title
Change in liver steatosis at 12-months
Description
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).
Time Frame
12-months
Title
Change in liver fibrosis at 6-months
Description
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).
Time Frame
6-months
Title
Change in liver fibrosis at 12-months
Description
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).
Time Frame
12-months
Title
Change in alanine aminotransferase (ALT) at 6-months
Description
Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 6-months.
Time Frame
6-months
Title
Change in alanine aminotransferase (ALT) at 12-months
Description
Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 12-months.
Time Frame
12-months
Title
Change in aspartate aminotransferase (AST) at 6-months
Description
Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 6-months.
Time Frame
6-months
Title
Change in aspartate aminotransferase (AST) at 12-months
Description
Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 12-months.
Time Frame
12-months
Title
Change in physical activity at 6-months
Description
An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 6-months.
Time Frame
6-months
Title
Change in physical activity at 12-months
Description
An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 12-months.
Time Frame
12-months
Title
Change in dietary intake at 6-months
Description
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.
Time Frame
6-months
Title
Change in dietary intake at 12-months
Description
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.
Time Frame
12-months
Title
Change in weight loss self-efficacy at 6-months: questionnaire
Description
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)).
Time Frame
6-months
Title
Change in weight loss self-efficacy at 12-months: questionnaire
Description
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)).
Time Frame
12-months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Sandoval
Phone
520-626-6000
Email
sponsor@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Garcia, PhD
Organizational Affiliation
University of Arizona, Mel & Enid Zuckerman College of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosi Vogel
Phone
520-626-7279
Email
rosimvogel@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Edgar Villavicencio
Phone
520-626-7279
Email
evillavicencio@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
David O. Garcia, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
25218670
Citation
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Results Reference
background
PubMed Identifier
26468154
Citation
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.
Results Reference
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PubMed Identifier
25976180
Citation
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.
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Citation
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.
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Citation
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Citation
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Results Reference
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PubMed Identifier
22278337
Citation
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.
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A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

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