NASHNCT05015491
Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
A study testing Noom Healthy Weight Program in people with NASH and Fatty Liver, run by Noom Inc. at 1 site in United States.
Trial summary
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NASH, Fatty Liver, NAFLD
- What is being tested?
- Noom Healthy Weight Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- NASH, Fatty Liver, NAFLD, Weight Loss
- Being tested
- Noom Healthy Weight Program
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom Healthy Weight ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Noom Healthy Weight Program | Experimental | 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). Receives: Behavioral: Noom Healthy Weight Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
BMI
Measured: baseline to day 112
Secondary outcomes (4)
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.
Measured: Baseline to day 112
Fibroscan - from baseline to day 112
Change in Liver Stiffness Measurement (LSM)
Measured: Baseline to day 112
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
Measured: Baseline to day 168
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.
Measured: Baseline to day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start9 Aug 2021
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arizona Liver Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015491
- Sponsor's protocol ID
- Noom 2021-01
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
- ClinicalTrials.gov ID
- NCT05015491
- Acronym / sponsor ID
- Noom 2021-01
- Conditions
- NASH, Fatty Liver, NAFLD, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Collaborators
- Arizona Liver Health
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noom Healthy Weight Program | Experimental | Behavioral: Noom Healthy Weight ProgramThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noom Healthy Weight ProgramThe 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. | Behavioural | Noom Healthy Weight Program |
Primary outcome
Change in BMI
Time frame: baseline to day 112
BMI
4 secondary outcomes
Fibroscan
Time frame: Baseline to day 112
Fibroscan - from baseline to day 112
Time frame: Baseline to day 112
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noom Healthy Weight Program in people with NASH and Fatty Liver, run by Noom Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: baseline to day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.