Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Reducing Barriers to Lifestyle Modification for Pediatric Patients of Hispanic Ethnicity and Newly Diagnosed MASLD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metabolic dysfunction-associated steatotic liver disease MASLD is the most common cause of liver disease in the world It is estimated that 38 of American children with obesity have steatotic liver disease Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD This study intends to provide insight to barriers of recommended care for pediatric patients with Hispanic ethnicity and a new diagnosis of MASLD The investigators propose to augment existing structural barriers related to health literacy food accessibility and dietary knowledge and access to safe physical activity through a healthy lifestyle toolkit and individualized nutritional counseling
Detailed Description:
The Hispanic population represents the largest and fastest growing ethnic group in the United States Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD An adult meta-analysis found a prevalence rate of 229 among individuals of Hispanic ethnicity A pediatric retrospective study found that children who are Hispanic are 5 times more likely to have MASLD than their agegender matched peers who identify as black The etiology of why individuals of Hispanic ethnicity are at higher risk of developing MASLD and subsequently associated co-morbidities such as insulin resistance diabetes and cardiovascular disease is thought to be multifactorial There is evidence to suggest that individuals of Hispanic ethnicity have a genetic predisposition for hepatic fat infiltration11 Additionally it has been postulated that social determinants of health such as economic stability and health care access and quality contribute to an increased risk
The American Association for the Study of Liver Diseases AASLD recommends lifestyle modification as the foundation of treatment for MASLD Implementing dietary changes and increasing physical activity contribute to weight loss which has been found to reduce hepatic steatosis A 7-10 weight loss can improve histopathological features of MASLD including fibrosisApplication of dietary modification such as adherence to the Mediterranean dietary pattern can decrease hepatic fat content even in the absence of weight lossThough lifestyle intervention has been found to be effective barriers to implementation exist In a study of adult patients of Hispanic ethnicity with a diagnosis of MASLD access to nutritious food and a safe exercising environment limited the ability to follow through with recommended lifestyle changesA survey study of pediatric patients with MASLD found that many lacked the opportunity for physical activity though the majority expressed an interest in participation16 Health literacy or the ability to obtain and comprehend medical information has also been found to be a barrier to effective care In a qualitative interview study of adults with MASLD health literacy was hindered by the availability of liver disease resources in the patients preferred language There is limited pediatric data regarding perceived barriers to implementing lifestyle changes With this study the investigators hope to minimize some of the social determinants of health that can impact Hispanic pediatric MASLD patients and help them participate in the recommended standard of care
The American Association for the Study of Liver Diseases AASLD recommends lifestyle modification as the foundation of treatment for MASLD Implementing dietary changes and increasing physical activity contribute to weight loss which has been found to reduce hepatic steatosis A 7-10 weight loss can improve histopathological features of MASLD including fibrosisApplication of dietary modification such as adherence to the Mediterranean dietary pattern can decrease hepatic fat content even in the absence of weight lossThough lifestyle intervention has been found to be effective barriers to implementation exist In a study of adult patients of Hispanic ethnicity with a diagnosis of MASLD access to nutritious food and a safe exercising environment limited the ability to follow through with recommended lifestyle changesA survey study of pediatric patients with MASLD found that many lacked the opportunity for physical activity though the majority expressed an interest in participation16 Health literacy or the ability to obtain and comprehend medical information has also been found to be a barrier to effective care In a qualitative interview study of adults with MASLD health literacy was hindered by the availability of liver disease resources in the patients preferred language There is limited pediatric data regarding perceived barriers to implementing lifestyle changes With this study the investigators hope to minimize some of the social determinants of health that can impact Hispanic pediatric MASLD patients and help them participate in the recommended standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None