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Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

Primary Purpose

NASH, Fatty Liver, NAFLD

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight Program
Sponsored by
Noom Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female, >18 years of age, inclusive, at Day -7.
  • BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -7.
  • Has no plan to change smoking habits during the study period.
  • Has ability to access study related online programs and apps.
  • Willing to follow study instructions, as well as complete online questionnaires.
  • Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.

Exclusion Criteria:

  • Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
  • Self-reported type 1 diabetes.
  • History of gastrointestinal surgery for weight reducing purposes.
  • Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -7.
  • Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
  • Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
  • Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
  • Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -7.
  • Exposure to any non-registered drug product within 30 d of Day -7.

  • Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or

    1½ oz distilled spirits).

  • ALT or AST > 5 x ULN at baseline.

Sites / Locations

  • Arizona Liver Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Noom Healthy Weight Program

Arm Description

The Noom platform uses a cognitive behavioral approach to weight loss that integrates set content with interaction with live coaches to support client efforts at behavior change. The Healthy Weight program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults". It has 52 weeks of curriculum with 1-3 articles to read per day (Reading level: Grade 6-8).

Outcomes

Primary Outcome Measures

Change in BMI
BMI

Secondary Outcome Measures

Fibroscan
Change in Controlled Attenuation Parameter (CAP) score CAP score is a measurement of fatty change in the liver. A CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m.
Fibroscan - from baseline to day 112
Change in Liver Stiffness Measurement (LSM)
Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score
This scale specifically evaluates self-efficacy judgments specific to eating behaviors in five situational factors: negative emotions, food availability, social pressure, physical discomfort, and positive activities. This measure has evidenced adequate psychometric properties, including internal consistency coefficients ranging from 0.76 to 0.90
Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).
The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved.

Full Information

First Posted
August 16, 2021
Last Updated
March 29, 2023
Sponsor
Noom Inc.
Collaborators
Arizona Liver Health
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1. Study Identification

Unique Protocol Identification Number
NCT05015491
Brief Title
Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
Official Title
A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.
Collaborators
Arizona Liver Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH, Fatty Liver, NAFLD, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noom Healthy Weight Program
Arm Type
Experimental
Arm Description
The Noom platform uses a cognitive behavioral approach to weight loss that integrates set content with interaction with live coaches to support client efforts at behavior change. The Healthy Weight program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults". It has 52 weeks of curriculum with 1-3 articles to read per day (Reading level: Grade 6-8).
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight Program
Intervention Description
The Healthy Weight program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults". Users are encouraged to log their weight (Weight Logging) at least 1x/week and log their food and beverages (Food Logging) daily. Exercise logging (steps via automatic collection or manually added) is done daily. The Noom Food color grading system is founded on calorie-density (Volumetrics diet, Barbara Rolls) and is a simple and effective method for creating long lasting changes in diet and food choice. Coaches are contacted via In-app messaging or phone communication.
Primary Outcome Measure Information:
Title
Change in BMI
Description
BMI
Time Frame
baseline to day 112
Secondary Outcome Measure Information:
Title
Fibroscan
Description
Change in Controlled Attenuation Parameter (CAP) score CAP score is a measurement of fatty change in the liver. A CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m.
Time Frame
Baseline to day 112
Title
Fibroscan - from baseline to day 112
Description
Change in Liver Stiffness Measurement (LSM)
Time Frame
Baseline to day 112
Title
Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score
Description
This scale specifically evaluates self-efficacy judgments specific to eating behaviors in five situational factors: negative emotions, food availability, social pressure, physical discomfort, and positive activities. This measure has evidenced adequate psychometric properties, including internal consistency coefficients ranging from 0.76 to 0.90
Time Frame
Baseline to day 168
Title
Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).
Description
The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time Frame
Baseline to day 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, >18 years of age, inclusive, at Day -7. BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -7. Has no plan to change smoking habits during the study period. Has ability to access study related online programs and apps. Willing to follow study instructions, as well as complete online questionnaires. Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator. Exclusion Criteria: Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI. Self-reported type 1 diabetes. History of gastrointestinal surgery for weight reducing purposes. Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -7. Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded. Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder. Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -7. Exposure to any non-registered drug product within 30 d of Day -7. Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits). ALT or AST > 5 x ULN at baseline.
Facility Information:
Facility Name
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

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