NAFLD and NASH Clinical Trial
Official title:
Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease
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.
Patients will be recruited primarily from the outpatient Liver Kirklin Clinic setting.
1. Informed consent will be obtained by one of the investigators named in the protocol or
by research coordinators involved with the study
2. Eligibility will be confirmed by interview and review of medical records using the
inclusion and exclusion criteria as listed above.
3. Complete history and physical examination will be recorded especially for weight and
body mass index, associated components of metabolic syndrome (diabetes, hypertension,
and dyslipidemia), liver enzymes, and current medications list.
4. All procedures such as imaging, endoscopy, and liver biopsy will be done as part of
standard routine care of these patients and no procedure will be done as part of this
research study.
5. Patients would be randomized to standard clinical care or to text messaging in addition
to standard clinical care. Standard clinical care includes obtaining data on history
and physical examination, routine blood work as part of liver disease care, ultrasound
and appropriate any other liver imaging as needed for patient care, counseling for at
least 7-10% weight loss with discussion on strategies to achieve this, management of
other risk factors including diabetes, hypertension, and dyslipidemia, and counseling
for compliance to taking medications and following up on future clinic visits. The
study investigator would be blinded to the randomization and which group the patient is
randomized to.
6. Patients would be followed at the end of 6 months period for assessing the study
outcomes as detailed earlier. Follow up for patients with stable liver disease is
usually done every 3-6 months. No additional clinic visits would be needed for this
study.
7. During these 6 months, patients would receive standard text messages as detailed later.
Patients will use their own cell phone to receive the text messages and reply to these
messages. There will be no additional intervention or device needed for this study
;