Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease

NCT03082703 | Completed

• 1 other identifier: X150420005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NAFLD and NASH

Outcome Measures

Primary Outcomes (1)

• Change in weight

  6 months

Study Arms (2)

Text Messaging

EXPERIMENTAL

Behavioral: Text Messaging

Control

NO INTERVENTION

Interventions

Text Messaging BEHAVIORAL

Subjects contacted 3 times weekly via text messaging for the study period.

Text Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Established patient at the UAB Kirklin clinic for at least 3-6 months
• Ownership of cell phone with text messaging service
• Ability to read and send text message

You may not qualify if:

• 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
• Refusal to consent for the study
• Pregnant females

Sponsors & Collaborators

• Ashwani Singal,MD: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: March 24, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share