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CompletedNCT03082703Updated Mar 17, 2017

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

An interventional study of Text Messaging in NAFLD and NASH, sponsored by Ashwani Singal,MD. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-17.

Sponsored by Ashwani Singal,MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • NAFLD and NASH
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

This is the only study on the registry with Ashwani Singal,MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Text Messaging

    Behavioral: Text Messaging

  • No intervention
    Control

Interventions

  • BehavioralText Messaging

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

06

What researchers measure

Primary outcomes

  1. Change in weight

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03082703
Lead sponsor
Ashwani Singal,MD
Responsible party
Ashwani Singal,MD (PI, University of Alabama at Birmingham) — Sponsor-investigator
First posted
Mar 17, 2017
Start date
Mar 24, 2016
Primary completion
Dec 1, 2016
Completion
Mar 1, 2017
Last update
Mar 17, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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