NASH - Nonalcoholic SteatohepatitisNCT06195943
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
A study testing Exercise Intervention with use of El-Fit App in people with NASH - Nonalcoholic Steatohepatitis and NASH, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, NASH, Exercise
- What is being tested?
- Exercise Intervention with use of El-Fit App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Mar 2026
- 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
- Adults age >18 years
- Evidence of NASH indicated by at least one of the following
- Liver biopsy with evidence of steatohepatitis (NAS >=4) within 6 months of the screening interval or;
- Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 >= 1.3 or; ii. NFS >= -1.44 or; iii. ELF >= 7.7 or; iv. VCTE kPa >=8 or; v. ARFI >=1.3 or; vi. FAST >= 0.35 or; vii. MRE kPa >=2.55 or; viii. MAST > 0.165 or;
- Possession of a smartphone
Who cannot join
- Active cardiac symptoms precluding participation in vigorous exercise
- Active or recent participation in exercise training program within the last 90 days
- Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use)
- Active illicit substance use
- Cancer that is active
- Cirrhosis
Show all 11Show fewer
- Exercise identified to be unsafe by study PI or EL-FIT mHealth program
- Inability to provide informed consent
- Inability to walk > 2 blocks
- Institutionalized/prisoner
- Other chronic liver disease (e.g., viral hepatitis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NASH, Exercise, Liver
- Being tested
- Exercise Intervention with use of El-Fit App
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention with use of El-Fit AppBehavioural
Along with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Application Useage Arm | Other | Along with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study. Receives: Behavioral: Exercise Intervention with use of El-Fit App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that complete at least 50% of the exercise sessions
The primary study endpoint is feasibility of the use of the application, which is defined as >50% of subjects adhering to the exercise prescribed, defined as completing >50% of the sessions.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Tondt, Milton S. Hershey Medical Center
- Investigators
- Justin G Tondt, MD, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195943
- Sponsor's protocol ID
- 22771
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2023
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT06195943
- Acronym / sponsor ID
- 22771
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NASH, Exercise, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 8 Jan 2024 (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 study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application Useage Arm | Other | Behavioral: Exercise Intervention with use of El-Fit AppAlong with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age >18 years
- Evidence of NASH indicated by at least one of the following
- Possession of a smartphone
Key exclusion criteria (11 listed)
- Active cardiac symptoms precluding participation in vigorous exercise
- Active or recent participation in exercise training program within the last 90 days
- Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use)
- Active illicit substance use
- Cancer that is active
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 |
|---|---|---|
| Exercise Intervention with use of El-Fit AppAlong with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study. | Behavioural | Application Useage Arm |
Primary outcome
Number of subjects that complete at least 50% of the exercise sessions
Time frame: 8 weeks
The primary study endpoint is feasibility of the use of the application, which is defined as >50% of subjects adhering to the exercise prescribed, defined as completing >50% of the sessions.
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 8 Apr 2026.
- 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.
Justin G Tondt, MD principal investigator
Penn State Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention with use of El-Fit App in people with NASH - Nonalcoholic Steatohepatitis and NASH, run by Milton S. Hershey Medical Center at 1 site in United States.
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 11 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of subjects that complete at least 50% of the exercise sessions (time frame: 8 weeks). 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 8 Apr 2026.