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.

Study Overview

• Status: Completed
• Conditions: NAFLD and NASH
• Intervention / Treatment: Behavioral: Text Messaging

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Text Messaging	Behavioral: Text Messaging; Subjects contacted 3 times weekly via text messaging for the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight	6 months

Collaborators and Investigators

• Sponsor: Ashwani Singal,MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: X150420005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No