NCT04872777

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

April 28, 2021

Last Update Submit

March 1, 2022

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Weight

    Change in self-measured body weight

    16 weeks

Secondary Outcomes (9)

  • liver enzymes

    16 weeks

  • Noom healthy weight engagement

    16 weeks

  • Glucose

    16 weeks

  • hemoglobin A1c

    16 weeks

  • Cholesterol level

    16 weeks

  • +4 more secondary outcomes

Study Arms (2)

Standard of care

NO INTERVENTION

Standard 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 Weight

EXPERIMENTAL

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.

Behavioral: Noom Healthy Weight

Interventions

Noom Healthy WeightBEHAVIORAL

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.

Noom Healthy Weight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Marietta, Pennsylvania, 17547, United States

Location

Related Publications (1)

  • 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.

    PMID: 36930864DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Jonathan G Stine, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Forty-subjects with NASH will be randomized 1:1 to either receive Noom HW mHealth lifestyle intervention or standard clinical care.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Penn State Liver Center, Assistant Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 5, 2021

Study Start

June 8, 2021

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)