NAFLD and NASH Clinical Trial
Official title:
Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease
Verified date | March 2017 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized study aims at examining the impact of text messaging in the management of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a disease frequently associated with obesity and varying components of metabolic syndrome including diabetes mellitus, hypertension, and dyslipidemia. With rising incidence of obesity in the US, NAFLD and NASH are rapidly increasing with currently the second etiology for liver transplantation in the US. The objectives of this protocol are to a) prospectively enroll patients with NAFLD and NASH; b) randomize them to receiving text messaging to help manage obesity and other components od metabolic syndrome in addition to standard clinical care or receiving only standard clinical care; and c) follow up these patients at the end of 3 months period for weight loss, blood pressure control, HBA1c, and liver enzymes. The immediate aim of this protocol is to develop the pilot data on the usefulness of text messaging in the management of NAFLD and NASH. The long-term goals of this research are to establish text messaging as a beneficial intervention in the management of weight loss and control of risk factors of NAFLD and improve outcomes of these patients with NAFLD and NASH.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 1, 2017 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with a diagnosis of NAFLD or NASH as determined with presence of steatosis and/or elevated liver enzymes, exclusion of other causes of liver disease, and history of alcohol use less than 10 g/d. 2. Age >18 years 3. Established patient at the UAB Kirklin clinic for at least 3-6 months 4. Ownership of cell phone with text messaging service 5. Ability to read and send text message Exclusion Criteria: 1. Failure to meet the inclusion criteria. 2. Any medical, psychiatric, or social conditions that, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject 3. Refusal to consent for the study 4. Pregnant females |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ashwani Singal,MD |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Change in weight | 6 months |