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Obesity & OverweightFLOURISHNCT07588984

GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study

An observational study of Obesity & Overweight and Weight Loss, run by Noom Inc. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Noom Weight, Free Tier and Semaglutide
How many people
2,310 participants
Where
1 siteUnited States
Study dates
30 Apr 2026to May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 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).

Who may be able to join

  • Speaks English
  • Community-dwelling, community-living status
  • Able to ambulate independently, with or without aids or devices
  • Unless medically indicated, willingness to stay on current program for 12 months and participate in all study activities
  • Provides informed consent for study participation
  • Commitment and willingness to participate, as assessed by completion of decisional balance exercise
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  • Program-specific eligibility:
  • Medication arms only: Meets standard of care program enrollment criteria for GLP-1 medication. Did not add other products or programs to Noom subscription.
  • Noom Weight only: Individual who is not interested in medication
  • Education-only Control Group: Individual who is interested in weight loss who is not currently enrolled in a structured weight loss program or medication program and does not intend to for the duration of the study Free Tier only: Willingness to use Free Tier

Who cannot join

  • Study screener completed more than 11 days after Noom program enrollment if participating in a Noom program (GLP-1 programs, Noom Weight, and Free Tier)
  • GLP-1 use in the last 24 weeks (prior to Noom program enrollment if in GLP-1 arm)
  • Female who is pregnant, breast-feeding, or intends to become pregnant during the 12-month program
  • Previous or planned (during the 12-month study) bariatric surgery
  • Active eating disorder
  • Active cancer
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  • Type 1 diabetes or current Insulin use
  • Currently taking a medication known to cause weight gain (e.g., antipsychotics, antidepressants, diabetes medication, or corticosteroids)
  • Depression screen results in a PHQ-8 score of 20 or greater.
  • 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:
  • GLP-1 agonist use is contraindicated (per program criteria) in members with:
  • Personal or family history of medullary thyroid cancer
  • Personal or family history of Multiple Endocrine Neoplasia Type 2 (MEN2)
  • Personal history of Pancreatitis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin C Owen, PhD, MPH contact

(929)-644-7193

erin.owen@noom.com

Marielle Darwin, PhD contact

(929)-644-7193

marielle.darwin@noom.com

United States1 site
  • Noom, Inc.

    Princeton, New Jersey, 08542

    Marielle Darwin, PhD, (929)-644-7193, marielle.darwin@noom.com

Other trials in United States

About this study

Official title: GLP-1 Medication & Behavioral Health on Weight and Metabolic Outcomes: FLOURISH (Functional Longitudinal Outcomes Under Intentional Small Habits) & THRIVE (Trajectories of Health, Resilience & Integrated Vitality Evaluation) Cohort Study

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).

Read more

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.

Read the detailed description

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.

Being tested
Noom Weight, Free Tier, Education-only control, Semaglutide, Tirzepatide
Keywords
GLP-1, Microdose, weight, body composition, metabolic, biomarkers, longevity, glucagon-like peptide-1, semaglutide, tirzepatide, microdosing, digital health, weight loss, behavioral health, real world evidence
Medical subject headings
Obesity, Overweight, Weight Loss, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noom WeightBehavioural

    Also called Noom

    App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.

  • Free TierBehavioural

    Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.

  • Education-only controlBehavioural

    Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.

  • SemaglutideDrug

    Also called Noom standard dose semaglutide

    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.

  • TirzepatideDrug

    Also called Noom standard dose tirzepatide

    Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.

  • Microdose semaglutideDrug

    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.

  • Microdose tirzepatideDrug

    Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.

Study groups in NCT07588984
Study groupRoleWhat they receive
Education only (control)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.
Receives: Behavioral: Education-only control
Noom WeightArm 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.
Receives: Behavioral: Noom Weight
Standard GLP-1RxArm 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.
Receives: Drug: Semaglutide
Microdose GLP-1RxArm 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.
Receives: Drug: Microdose semaglutide
Noom PlusArm 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.
Receives: Drug: Tirzepatide
Noom Plus MicrodoseArm 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.
Receives: Drug: Microdose tirzepatide
Noom Free Tier (control)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.
Receives: Behavioral: Free Tier
Proactive HealthArm 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.
Receives: Drug: Microdose semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight

    Change from baseline in body weight (kg/lbs) measured via connected scale.

    Measured: Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)

  2. Change in fasting glucose

    Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  3. Change in HbA1c

    Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  4. Change in LDL cholesterol

    Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  5. Change in HDL cholesterol

    Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  6. Change in total cholesterol

    Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  7. Change in triglycerides

    Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

    Measured: Baseline, Month 2, Month 4, Month 8, Month 12

  8. Change in Body Composition

    Change from baseline in estimated body composition metrics (lean mass, fat mass percentage) as measured via in-app BodyScan feature.

    Measured: Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)

  9. 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.

    Measured: Baseline (pre-treatment), Monthly through Month 12

Secondary outcomes (6)
  1. 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).

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

  2. Change in resting heart rate (RHR)

    Change in resting heart rate (RHR) from baseline measured via wearables (select arms).

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

  3. Change in Peripheral Capillary Oxygen Saturation (SpO2)

    Change in Peripheral Capillary Oxygen Saturation (SpO2) from baseline measured via wearables (select arms).

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

  4. Change in sleep duration

    Change in sleep duration (hours and minutes) from baseline measured via wearables (select arms).

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

  5. 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).

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

  6. 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.

    Measured: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588984
Sponsor's protocol ID
RX6014: FLOURISH and THRIVE
Acronym
FLOURISH
Status last verified
May 2026
First submitted
30 Apr 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity & Overweight and Weight Loss, 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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 15 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin C Owen, PhD, MPH ((929)-644-7193, erin.owen@noom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)). The study lists 9 primary outcomes in all. 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 15 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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