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| Name | Class |
|---|---|
| Noom Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Standard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control:
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| Noom Healthy Weight | Experimental | Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noom Healthy Weight | Behavioral | Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention:
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in self-measured body weight | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| liver enzymes | Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP)) | 16 weeks |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan G Stine, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Marietta | Pennsylvania | 17547 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36930864 | Derived | 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. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Forty-subjects with NASH will be randomized 1:1 to either receive Noom HW mHealth lifestyle intervention or standard clinical care.
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| 16 weeks |
| Glucose | Change in blood glucose mg/dL | 16 weeks |
| hemoglobin A1c | Change hemoglobin A1c (%) | 16 weeks |
| Cholesterol level | Change in cholesterol mg/dL | 16 weeks |
| NAFLD Fibrosis Score | change in NAFLD Fibrosis Score | 16 weeks |
| IgA level | Change in IgA level mg/dL | 16 weeks |
| Ferritin | Change in Ferritin ng/mL | 16 weeks |
| histology | Change in transient elastography or liver histology | 16 weeks |