- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05015491
Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
November 9, 2023 updated by: Noom Inc.
A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Chandler, Arizona, United States, 85224
- Arizona Liver Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Noom Healthy Weight Program
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).
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BMI
Time Frame: baseline to day 112
|
BMI
|
baseline to day 112
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibroscan
Time Frame: Baseline to day 112
|
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.
|
Baseline to day 112
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Fibroscan - from baseline to day 112
Time Frame: Baseline to day 112
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Change in Liver Stiffness Measurement (LSM)
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Baseline to day 112
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Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score
Time Frame: Baseline to day 168
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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
|
Baseline to day 168
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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).
Time Frame: Baseline to day 168
|
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.
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Baseline to day 168
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2021
Primary Completion (Actual)
September 12, 2022
Study Completion (Actual)
September 12, 2022
Study Registration Dates
First Submitted
August 16, 2021
First Submitted That Met QC Criteria
August 16, 2021
First Posted (Actual)
August 20, 2021
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Noom 2021-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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