NAFLD and NASHNCT03082703
Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease
A study testing Text Messaging in people with NAFLD and NASH, run by Ashwani Singal,MD.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD and NASH
- What is being tested?
- Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- Failure to meet the inclusion criteria.
- 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
About this study
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.
- Informed consent will be obtained by one of the investigators named in the protocol or by research coordinators involved with the study
- Eligibility will be confirmed by interview and review of medical records using the inclusion and exclusion criteria as listed above.
- 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.
- 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.
- 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.
- 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.
- 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
- Conditions
- NAFLD and NASH
- Being tested
- Text Messaging
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
Subjects contacted 3 times weekly via text messaging for the study period.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging | Experimental | Not described Receives: Behavioral: Text Messaging |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start24 Mar 2016
- Primary completion1 Dec 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD and NASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashwani Singal,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ashwani Singal,MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082703
- Sponsor's protocol ID
- X150420005
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03082703
- Acronym / sponsor ID
- X150420005
- Conditions
- NAFLD and NASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ashwani Singal,MDUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be recruited primarily from the outpatient Liver Kirklin Clinic setting.
- Informed consent will be obtained by one of the investigators named in the protocol or by research coordinators involved with the study
- Eligibility will be confirmed by interview and review of medical records using the inclusion and exclusion criteria as listed above.
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging | Experimental | Behavioral: Text Messaging |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- Failure to meet the inclusion criteria.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessagingSubjects contacted 3 times weekly via text messaging for the study period. | Behavioural | Text Messaging |
Primary outcome
Change in weight
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging in people with NAFLD and NASH, run by Ashwani Singal,MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.