Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

NCT ID: NCT04872777

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2022-02-10

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.

Conditions

Non-alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Noom Healthy Weight

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.

Group Type: EXPERIMENTAL

Noom Healthy Weight

Intervention Type: BEHAVIORAL

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.

Interventions

Noom Healthy Weight

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noom Inc.

INDUSTRY

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Stine

Director of Research, Penn State Liver Center, Assistant Professor of Medicine and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan G Stine, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Marietta, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36930864 (View on PubMed)

Other Identifiers

STUDY00017544

Identifier Type: -

Identifier Source: org_study_id