An interventional study of YMCA class in Weight Loss, NAFLD and Liver Diseases, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research
This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.
This study is for men and women who participate in the YMCA's Diabetes Prevention Program (YMCA's DPP) and have been diagnosed with non-alcoholic fatty liver disease (NAFLD). There will be no administration of study drug. The purpose of this study is to see if participation in the YMCA's DPP will result in weight loss and improvement in the liver in patients with fatty liver disease.
Eligible participants will visit Weill Cornell Medical College's Gastroenterology and Hepatology clinic to review their medical history, physical examination, complete a survey, and conduct imaging tests (FibroScan, ultrasound, DEXA scan) for their baseline visit. Blood will be collected as part of standard practice. An additional blood sample will be collected for storage. Subjects will complete 9 out of 16 weekly sessions. The YMCA's program will be conducted at Weill Cornell Medical College Gastroenterology and Hepatology Division.
Participants will be in the YMCA program for about 1 year and an additional 1 year in the long-term follow-up for data collection.
Participants will be compensated for their time.
Key eligibility criteria:
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
This Arm's objective is to determine the effect of the YMCA's Diabetes Prevention Program on NAFLD as determined by comparison of liver enzymes pre- and post- program.
Behavioral: YMCA class
The Gastroenterologists of Weill Cornell Medical College that are associated with this trial want to implement the YMCA's DPP in the NAFLD population as a structured lifestyle modification/educational intervention. The hypothesis is that the NAFLD patients who complete the YMCA's DPP will also have weight loss and improvement in hepatic steatosis. Importantly, positive results in this New York City-based pilot study would provide a strong rationale for determining whether such a program could be useful to treat NAFLD at established YMCA DPP sites across the country.
Effect of the YMCA's Diabetes Prevention Program on NAFLD
Determine the effect of the YMCA's Diabetes Prevention Program on NAFLD as determined by comparison of liver enzymes pre- and post- program - we'll look at the changes of ALT levels to determine the aforementioned. We will perform these diagnostic tests in order to determine the effectiveness of the 16 weeks of sessions.
Time frame: 104 weeks from the start of the study
Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program
Evaluate the amount of liver fat as determined by Fibroscan Controlled Attenuation Pattern (CAP) score in patients with NAFLD pre- and post- participation in the diabetes prevention program with the YMCA. The CAP range should be 100-400, without any sub-scales reported. Lower values in the range represent less 'fat', making it a better score.
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires
Determine the effect of YMCA's DPP on quality of life in patients with NAFLD as per SF-36 questionnaire.
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per each patient's BMI
Determine the effect of YMCA's DPP on BMI in patients with NAFLD. We are reporting this as an aggregate of Body Mass Index.
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per the DEXA scan
Determine the effect of YMCA's DPP on body composition (aggregated via body fat percentage and lean and fat body mass) using dual-energy X-ray absorptiometry (DEXA).
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed
Determine the effect of YMCA's DPP on levels of systemic factors linked to the metabolic syndrome. The metabolites that will be studied are all research-related blood work.
Time frame: 104 weeks from the start of the study
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University