Non-Alcoholic Fatty Liver DiseaseNCT03839082

Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

A study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will look at physical activity and nutrition in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as an addition to their usual clinical care… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2019to 26 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
Ability to participate in physical activity

Who cannot join

Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
History of decompensated cirrhosis
Plans for invasive procedures or other regimented lifestyle programs for weight reduction
Cardiovascular event in the previous 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

Conditions: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Being tested: Usual Care then FitBit, FitBit then Usual Care
Keywords: Mobile Technology, Weight, Nutrition
Medical subject headings: Non-alcoholic Fatty Liver Disease, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual Care then FitBitOther
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
FitBit then Usual CareOther
Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.

Study groups in NCT03839082
Study group	Role	What they receive
Usual Care then FitBit	Active comparator	This is the waitlist control arm. Receives: Other: Usual Care then FitBit; Other: FitBit then Usual Care
FitBit then Usual Care	Experimental	Intervention includes education, physical activity, and a nutrition assessment. Receives: Other: Usual Care then FitBit; Other: FitBit then Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat).
Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP
12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.
Measured: Baseline, 6 months,

Secondary outcomes (2)

Percent Change in Body Weight
Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline
Measured: Baseline, 6 months
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500.
Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active.
Insufficient paired results existed to provide percent change measurements. Medians overall are provided.
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201926 Feb 2021

First posted15 Feb 2019
Study start20 Mar 2019
Primary completion26 Feb 2021
Study completion26 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03839082
Sponsor's protocol ID: HUM00153750
Status last verified: Apr 2022
First submitted: 11 Feb 2019
Last updated: 3 May 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-Alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
ClinicalTrials.gov ID: NCT03839082
Acronym / sponsor ID: HUM00153750
Conditions: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Keywords: Mobile Technology, Weight, Nutrition
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: American Association for the Study of Liver Diseases
Study start: 20 Mar 2019 (actual)
Primary completion: 26 Feb 2021 (actual)
Study completion: 26 Feb 2021 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 3 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care then FitBit	Active comparator	Other: Usual Care then FitBit, Other: FitBit then Usual CareThis is the waitlist control arm.
FitBit then Usual Care	Experimental	Other: Usual Care then FitBit, Other: FitBit then Usual CareIntervention includes education, physical activity, and a nutrition assessment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
Ability to participate in physical activity

Key exclusion criteria (4 listed)

Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
History of decompensated cirrhosis
Plans for invasive procedures or other regimented lifestyle programs for weight reduction
Cardiovascular event in the previous 3 months

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
Usual Care then FitBitUsual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).	Other	FitBit then Usual Care, Usual Care then FitBit
FitBit then Usual CareIntervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Other	FitBit then Usual Care, Usual Care then FitBit

Primary outcome

Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
Time frame: Baseline, 6 months,
CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat). Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP 12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.

2 secondary outcomes

Percent Change in Body Weight
Time frame: Baseline, 6 months
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 6 months

Results and safety

Results posted to the registry on 3 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FitBit Then Usual Care	33	7
Usual Care Then FitBit	37	12

Primary outcome: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score

Time frame: Baseline, 6 months,. Median (Inter-Quartile Range). Unit: percent change

Measure	FitBit n = 1	Usual Care n = 5
Value	-13.0	8.7 (-3.3 to 16.2)

Population analysed: Due to the disruption caused by the COVID epidemic, follow up was dramatically lower than planned, and values were missing for some individuals in both arms.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: While in study - up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FitBit	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Usual Care	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Non-Alcoholic Fatty Liver Disease

Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
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Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
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RecruitingPhase 2
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Overweight and/or Obesity, Metabolic Syndrome

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.

Monica Konerman principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by University of Michigan 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 3 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 3 May 2022. 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?

Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score (time frame: Baseline, 6 months,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03839082.

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 3 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.