An observational study in Obesity & Overweight, Weight Loss and Preventative Health, sponsored by Noom Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Noom Inc. · Observational
This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement.
FLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Plus Microdose).
THRIVE is a nested 2-arm prospective study comparing a Proactive Health program to a Noom Free Tier control.
Participants complete monthly surveys, remote biomarker collection (Tasso device), connected-scale weigh-ins, and in-app biometric assessments (FaceScan, BodyScan). Microdose and Free Tier arms also use wearable fitness trackers. Primary outcomes are changes in cardiometabolic biomarkers, weight, body composition, and GLP-1 side effect profile. Total N = 2,310; 24-month duration.
FLOURISH (Functional Longitudinal Outcomes Under Repeated Intentional Small Habits) and THRIVE (Trajectories of Health, Resilience \& Integrated Vitality Evaluation) are designed to evaluate whether GLP-1 medications paired with a behavioral health digital companion delivered via the Noom application produce clinically meaningful improvements in weight, cardiometabolic biomarkers, physiological indicators, and patient-reported outcomes.
All programs are commercially available Noom offerings. Research activities supplement but do not alter standard program care. Participants are recruited from active program users after program enrollment (GLP-1 programs, Noom Weight, Free Tier arms) or via an electronic recruitment platform (Education-only control).
Measurement occurs at baseline and monthly through month 12, with additional follow-ups at months 18 and 24 for GLP-1 arms. Biomarker collection uses the FDA-cleared Tasso+ capillary blood device at baseline and months 2, 4, 8, and 12. Connected scales provide monthly weight data. Wearable fitness trackers (arm-specific) provide continuous physiological data including resting heart rate, HRV, SpO2, and sleep. In-app BodyScan and FaceScan capture body composition and HRV estimates monthly.
Self-report measures assess depression (PHQ-8), anxiety (GAD-7), sleep (PROMIS Sleep Disturbance), vitality (Subjective Vitality Scale), health-related quality of life (PROMIS PROPr), flourishing (PERMA), appetite and food cravings (Mind-Eat, Food Noise Questionnaire, PACS), and GLP-1 side effects and medication adherence.
Conflict of interest: Noom, Inc. is both sponsor and developer of the interventions under study. This is disclosed to all participants and will be reported in publications.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 2,310 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Noom Inc. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes individuals enrolled in Noom commercially available programs and individuals interested in weight loss not enrolled in a weight management program (education-only control group).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All medicated arms and Noom Weight arms (only):
- Purchased more than the base Noom program offered for participant's specific arm
GLP-1 Medication Arms Only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1 of FLOURISH: This is an active control condition in which participants will receive weekly informational newsletters for 12 months. This group will not have access to the Noom app (except for research purposes) and will not receive GLP-1 medications.
Behavioral: Education-only control
Arm 2 of FLOURISH: Noom Weight users will have access to all in-app features. This group will not receive GLP-1 medications. Followed for 12 months.
Behavioral: Noom Weight
Arm 3 of FLOURISH: Standard GLP-1 users will follow a protocol for Noom's standard dose of compounded semaglutide and will have access to all in-app features. Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
Drug: Semaglutide
Arm 4 of FLOURISH: Microdose GLP-1 users will follow a microdose protocol of compounded semaglutide and will have access to all in-app features. Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
Drug: Microdose semaglutide
Arm 5 of FLOURISH: Participants will follow a protocol for Noom's standard dose of compounded tirzepatide and will have access to all in-app features. Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
Drug: Tirzepatide
Arm 6 of FLOURISH: Noom Plus Microdose users will follow a microdose protocol for compounded tirzepatide and will have access to all in-app features. Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
Drug: Microdose tirzepatide
Arm 1 of THRIVE: This is an active control condition in which users enrolled in Noom's Free Tier program will have access to app features available to Free Tier. This group will not receive GLP-1 medications. Followed for 12 months.
Behavioral: Free Tier
Arm 2 of THRIVE: Proactive health users will follow the microdose protocol for compounded semaglutide indicated for preventive health/longevity. They will have access to all in-app features. Followed for 12 months.
Drug: Microdose semaglutide
App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
Also known as: Noom
Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
Standard clinical dosing of compounded semaglutide as part of Noom Med GLP-1Rx program per clinical standard of care, combined with behavioral coaching via the Noom app.
Also known as: Noom standard dose semaglutide
Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
Also known as: Noom standard dose tirzepatide
Below-standard clinical dosing (microdose) of compounded semaglutide as part of Noom Med GLP-1Rx Microdose program, combined with behavioral coaching via the Noom app.
Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
Change in Body Weight
Change from baseline in body weight (kg/lbs) measured via connected scale.
Time frame: Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
Change in fasting glucose
Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in HbA1c
Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in LDL cholesterol
Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in HDL cholesterol
Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in total cholesterol
Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in triglycerides
Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Time frame: Baseline, Month 2, Month 4, Month 8, Month 12
Change in Body Composition
Change from baseline in estimated body composition metrics (lean mass, fat mass percentage) as measured via in-app BodyScan feature.
Time frame: Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)
GLP-1 Side Effect Profile
Number, severity, and tolerance of GLP-1 medication-related side effects (nausea, vomiting, diarrhea, constipation, headache, fatigue, injection site reactions) assessed via monthly self-report. Applicable to GLP-1 arms only.
Time frame: Baseline (pre-treatment), Monthly through Month 12
Change in heart rate variability (HRV)
Change in heart rate variability (HRV) from baseline measured via in-app FaceScan feature (all arms) and wearables (select arms).
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in resting heart rate (RHR)
Change in resting heart rate (RHR) from baseline measured via wearables (select arms).
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in Peripheral Capillary Oxygen Saturation (SpO2)
Change in Peripheral Capillary Oxygen Saturation (SpO2) from baseline measured via wearables (select arms).
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in sleep duration
Change in sleep duration (hours and minutes) from baseline measured via wearables (select arms).
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in time spent in sleep stages
Change in time spent in sleep stages (hours and minutes spent in each sleep stage) from baseline measured via wearables (select arms).
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in sleep continuity
Change from baseline in wearable-derived sleep continuity, assessed as sleep onset latency (SOL) and wake after sleep onset (WASO), measured in minutes.
Time frame: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Depression symptoms
Change from baseline in Patient Health Questionnaire-8 (PHQ-8) score. Minimum score = 0; maximum score = 24. Lower score indicate none/mild depression; higher scores indicate severe depression.
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Anxiety symptoms
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score. Minimum score = 0; maximum score = 21. Lower scores = minimal or no anxiety; higher scores = severe anxiety.
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Sleep disturbance
Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8-item scale. Minimum score = 8; maximum score = 40. Lower scores = minimal or no sleep disturbance; higher scores = severe sleep disturbance.
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Energy and Vitality
Change from baseline on Subjective Vitality Scale. Minimum score = 6; maximum score = 42. Lower scores = worse outcome (lower energy and vitality); higher scores = better outcome (more energy and vitality)
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Health-related quality of life (HRQoL)
Change from baseline on PROMIS PROPr composite score. Minimum score = -.022; maximum score = 1. Lower scores = worse outcome/health status ; higher scores = optimal health-related quality of life.
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Flourishing & Wellbeing
Change from baseline on PERMA questionnaire total and subscale scores. Scores on each of the 5 subscales range from 0-10, with lower scores indicating significant challenges in that domain and higher scores indicating that domain is a strong source of wellbeing.
Time frame: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Change in appetite
Change from baseline on Mind-Eat Scale. Minimum score = 24 maximum score = 120. Lower scores = low mindful eating; higher scores = highly mindful eating.
Time frame: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
Change in food noise
Change from baseline on Food Noise Questionnaire. Minimum score = 0 maximum score = 20. Lower scores = low food noise higher scores = high food noise/preoccupation
Time frame: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
Change in cravings
Change from baseline on Penn Alcohol Cravings Scale. Minimum score = 0 maximum score = 30. Lower scores = no craving; high scores = severe craving.
Time frame: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
Change in health conditions
Changes in health conditions will be assessed via self-report items related to presence of new health condition(s) and changes in pre-existing health conditions.
Time frame: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
Change in medications
Change in medications will be assessed via self-report items related to users starting new medications, stopping previous medications, and/or dose changes in medications.
Time frame: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
Adverse event reporting
Adverse events will be assessed by self-reported hospitalizations and urgent care visits, type of care received during visits, complications/functional impairment related to adverse event(s), and resolution of adverse event(s).
Time frame: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
GLP-1 discontinuation measure
GLP-1 Treatment Continuation and Discontinuation Self-Efficacy surveys will assess participants' weight goals, confidence in meeting goals and self-efficacy related to skills and behaviors important to weight management after GLP-1 discontinuation.
Time frame: Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)
Program Engagement
Number of participant in-app actions (e.g., what type of app clicks occur within the application user interface), rolled up by count per day within each action type: medication adherence, nutrition, physical activity, shaping knowledge, accountability, health assessment, social, and mood-boosting.
Time frame: Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
Plan to share: No
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