Weight LossNCT04797169
Noom Health for Weight Management
A study testing Noom Health and Noom Digital Health in people with Weight Loss and Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Noom Health and Noom Digital Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 4 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be interested in the Noom app
- BMI > 27 kg/m2
- Ages of 18 and 60 at entry to the study
- Speak English
Who cannot join
- Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)
- Acute suicide risk
- Pregnant or planning to become pregnant during the study
- Current Noom use
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10028
About this study
The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.
Read the detailed description
A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.
Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).
In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.
During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).
- Conditions
- Weight Loss, Obesity
- Being tested
- Noom Health, Noom Digital Health
- Keywords
- Weight Loss, Mobile App, Digital Health, Weight Loss Maintenance, Weight Loss Suppression, Obesity
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom HealthBehavioural
In Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.
Noom Digital HealthBehavioural
In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.
| Study group | Role | What they receive |
|---|---|---|
| Noom Health | Experimental | Not described Receives: Behavioral: Noom Health |
| Noom Digital Health | Active comparator | Not described Receives: Behavioral: Noom Digital Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight From Baseline
Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.
Measured: Baseline, 6 months and 30 Months
Secondary outcomes (14)
Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months
Caloric intake at 30 months as compared to baseline. Caloric intake will be measured using the ASA24 dietary recall system.
Measured: Baseline and 30 Months
Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months
EDE-Q global score at 30 months as compared to baseline. Dietary restraint, eating, shape, and weight concerns are measured with the EDE-Q. These subscales are summed and then divided by the total number of subscales (4) to create a global score. Scores range from 0 to 52 with higher scores indicating higher severity.
Measured: Baseline and 30 Months
Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months
Physical activity at 30 months as compared to baseline. The IPAQ includes 27 items and determines a MET value for time spent in an average week completing different levels of activity including vigorous or moderate physical activity, walking, and sitting. One MET is the energy spent sitting at rest.
Measured: Baseline and 30 Months
Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Depression subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.
Measured: Baseline and 30 Months
Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Anxiety subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.
Measured: Baseline and 30 Months
Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Stress subscale score at 30 months as compared to baseline. DASS a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.
Measured: Baseline and 30 Months
Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months
Sleep impairment at 30 months as compared to baseline. The PROMIS Sleep Related Impairment v.1.0 is a 16-item self-report measure of perceived functioning during waking hours in relation to tiredness and trouble sleeping. A raw score is calculated by summing all individual items and is translated into a T-score with standard error (SE). A T-score of 50 indicates normal impairment compared to the general population, scores above 50 indicate more impairment.
Measured: Baseline and 30 Months
Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months
PCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 17.2- 66.7 with lower scores indicating worse quality of life related to physical health.
Measured: Baseline and 30 Months
Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months
MCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 12.7-64.2 with lower scores indicating worse quality of life related to mental health.
Measured: Baseline and 30 Months
Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months
Self-efficacy at 30 months as compared to baseline. The DIET-SE is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy.
Measured: Baseline and 30 Months
Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months
The percent of available features on the app, expected verses completed at 6 months
Measured: 6 Months
Number of Participants With 12-Month Completion Status
Attrition at 12 months as compared to number randomized at baseline documented using completion status
Measured: 12 Months
Percent of Successful Technological Fixes
App compatibility will be examined by calculating the percent of successful technological fixes at 12 months as compared to baseline. The type of technological problems encountered by participants while using the app and any fixes needed will be categorized.
Measured: Baseline and 12 Months
Change in CDC NCHS National Health Interview Survey
Changes in health status from baseline to 30-months as measured by questions from the CDC NCHS National Health Interview Survey. Using an adapted version of the CDC NCHS National Health Interview Survey, the survey includes 4 questions about healthcare utilization. Items identify type of healthcare sought and frequency. The frequency of provider visits will be calculated to determine healthcare utilization. A frequency score of zero indicates no healthcare utilized. There is no upper limit for the frequency.
Measured: Baseline and 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start22 Mar 2021
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two conditions in a parallel design including a 12-month intervention. Participants will be openly-enrolled over the course of 12-months until the recruitment goal of 600, 300 in each group, is reached.
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Noom Inc.
- Responsible party
- Principal investigator, Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Hildebrandt, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797169
- Sponsor's protocol ID
- GCO 20-2224
- Status last verified
- Jul 2025
- First submitted
- 10 Mar 2021
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sysko R, Bibeau J, Boyar A, Costello K, Michaelides A, Mitchell ES, Susanin A, Hildebrandt T. A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.
PubMed 35969439
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noom Health for Weight Management
- ClinicalTrials.gov ID
- NCT04797169
- Acronym / sponsor ID
- GCO 20-2224
- Conditions
- Weight Loss, Obesity
- Keywords
- Weight Loss, Mobile App, Digital Health, Weight Loss Maintenance, Weight Loss Suppression, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Noom Inc.
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.
Detailed description
A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.
Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).
In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.
During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions in a parallel design including a 12-month intervention. Participants will be openly-enrolled over the course of 12-months until the recruitment goal of 600, 300 in each group, is reached.
| Arm | Type | Receives |
|---|---|---|
| Noom Health | Experimental | Behavioral: Noom Health |
| Noom Digital Health | Active comparator | Behavioral: Noom Digital Health |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be interested in the Noom app
- BMI > 27 kg/m2
- Ages of 18 and 60 at entry to the study
- Speak English
Key exclusion criteria (4 listed)
- Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)
- Acute suicide risk
- Pregnant or planning to become pregnant during the study
- Current Noom use
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 HealthIn Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss. | Behavioural | Noom Health |
| Noom Digital HealthIn Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content. | Behavioural | Noom Digital Health |
Primary outcome
Change in Weight From Baseline
Time frame: Baseline, 6 months and 30 Months
Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.
14 secondary outcomes
Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months
Time frame: Baseline and 30 Months
Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months
Time frame: 6 Months
Number of Participants With 12-Month Completion Status
Time frame: 12 Months
Percent of Successful Technological Fixes
Time frame: Baseline and 12 Months
Change in CDC NCHS National Health Interview Survey
Time frame: Baseline and 30 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35969439Sysko R, Bibeau J, Boyar A, Costello K, Michaelides A, Mitchell ES, Susanin A, Hildebrandt T. A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.
- 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.
Thomas Hildebrandt, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
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 Health and Noom Digital Health in people with Weight Loss and Obesity, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 4 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 11 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Weight From Baseline (time frame: Baseline, 6 months and 30 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797169, which also lists 1 linked publication.
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 11 Aug 2025.