AzTrials
AzTrials

Non-alcoholic SteatohepatitisNCT04872777

Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

A study testing Noom Healthy Weight in people with Non-alcoholic Steatohepatitis, run by Milton S. Hershey Medical Center 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
Search all trials

Trial summary

There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-alcoholic Steatohepatitis
What is being tested?
Noom Healthy Weight
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
8 Jun 2021to 10 Feb 2022
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
  • NASH defined as:
  • Liver biopsy with evidence of steatohepatitis (NAS >=4) or;
  • Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
  • Fibroscan kPa >8.2 or;
  • FAST > 0.35 or;
  • FIB-4 >= 1.45 or;
  • Possession of a smartphone

Who cannot join

  • Active or recent (<90 days) participation in lifestyle intervention program, including weight-loss program
  • Active weight-loss supplement use
  • Cirrhosis
  • Inability to provide informed consent
  • Institutionalized/prisoner
  • Other chronic liver disease (e.g., viral hepatitis)
Show all 9Show fewer
  • Recent Noom use (<180 days)
  • Secondary cause of hepatic steatosis, including significant alcohol consumption (men >30g/d, women >20g/d)
  • Severe medical comorbidities/psychiatric illness at the discretion of the study PI

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Hershey Medical Center

    Marietta, Pennsylvania, 17547

Other trials in United States

About this study

Official title: Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study

There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform.

This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH.

Being tested
Noom Healthy Weight
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.

  • Noom Healthy WeightBehavioural

    Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention:

    1. Noom application set-up and troubleshooting on smartphone (license provided)
    2. Digital scale provision (subjects may keep the scale)
    3. Capture of available clinical information over preceding 28-days.
Study groups in NCT04872777
Study groupRoleWhat they receive
Standard of careNo interventionStandard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control: 1. Digital scale provision (subjects may keep the scale) 2. Reinforcement of need to comply with SOC treatment as directed by their NASH clinician 3. Capture of available clinical information over preceding 28-days.
Noom Healthy WeightExperimentalFollowing study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention: 1. Noom application set-up and troubleshooting on smartphone (license provided) 2. Digital scale provision (subjects may keep the scale) 3. Capture of available clinical information over preceding 28-days.
Receives: Behavioral: Noom Healthy Weight

What is being measured

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

  1. Weight

    Change in self-measured body weight

    Measured: 16 weeks

Secondary outcomes (9)

  1. liver enzymes

    Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))

    Measured: 16 weeks

  2. Noom healthy weight engagement

    Feasibility will be assessed according to user engagement. Engaged users are defined as those who complete at least one meaningful in-application action per week (e.g., weight log, food log, exercise log, article read).

    Measured: 16 weeks

  3. Glucose

    Change in blood glucose mg/dL

    Measured: 16 weeks

  4. hemoglobin A1c

    Change hemoglobin A1c (%)

    Measured: 16 weeks

  5. Cholesterol level

    Change in cholesterol mg/dL

    Measured: 16 weeks

  6. NAFLD Fibrosis Score

    change in NAFLD Fibrosis Score

    Measured: 16 weeks

  7. IgA level

    Change in IgA level mg/dL

    Measured: 16 weeks

  8. Ferritin

    Change in Ferritin ng/mL

    Measured: 16 weeks

  9. histology

    Change in transient elastography or liver histology

    Measured: 16 weeks

Timeline

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

  1. First posted5 May 2021
  2. Study start8 Jun 2021
  3. Primary completion10 Feb 2022
  4. Study completion10 Feb 2022

Resources

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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04872777
Sponsor's protocol ID
STUDY00017544
Status last verified
Mar 2022
First submitted
28 Apr 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stine JG, Rivas G, Hummer B, Duarte-Rojo A, May CN, Geyer N, Chinchilli VM, Conroy DE, Mitchell ES, McCallum M, Michealides A, Schmitz KH. Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH. Hepatol Commun. 2023 Mar 17;7(4):e0052. doi: 10.1097/HC9.0000000000000052. eCollection 2023 Apr 1.

    PubMed 36930864

Questions about this trial

What is this clinical trial studying?

A study testing Noom Healthy Weight in people with Non-alcoholic Steatohepatitis, 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 8 inclusion and 9 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 2 Mar 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?

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?

Weight (time frame: 16 weeks). 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 NCT04872777, which also lists 1 linked publication.

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 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in