FLOURISH

Not yet recruiting

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

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

Lead sponsor

Noom Inc.

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

2,310

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Body weight, absolute change (kg)•Fasting glucose, change•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07588984

Org study IDRX6014: FLOURISH and THRIVE

Timeline

Milestones

Study start2026-04-30estimated

Study first posted2026-05-15actual

Last update posted2026-05-15actual

Primary completion2029-05estimated (month precision)

Study completion2029-05estimated (month precision)

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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).

Inclusion criteria

•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

•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

Exclusion criteria

•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

•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

Endpoints (29)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

Change in Body Weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

Change in Body Composition

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

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in fasting glucose

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change in HbA1c

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

6 endpoints

Primary/protocol endpoint

Change in LDL cholesterol

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Primary/protocol endpoint

Change in HDL cholesterol

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Primary/protocol endpoint

Change in total cholesterol

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Primary/protocol endpoint

Change in triglycerides

Time frame:Baseline, Month 2, Month 4, Month 8, Month 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in heart rate variability (HRV)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in resting heart rate (RHR)

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

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

9 endpoints

Other/protocol endpoint

Depression symptoms

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Anxiety symptoms

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Sleep disturbance

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Energy and Vitality

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Health-related quality of life (HRQoL)

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Flourishing & Wellbeing

Time frame:Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Change in appetite

Time frame:Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

Change in food noise

Time frame:Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)

change from baseline, improvement

Other/protocol endpoint

GLP-1 discontinuation measure

Time frame:Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

GLP-1 Side Effect Profile

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

descriptive

Other/protocol endpoint

Adverse event reporting

Time frame:Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

Change in Peripheral Capillary Oxygen Saturation (SpO2)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in sleep duration

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

change from baseline, improvement

Secondary/protocol endpoint

Change in time spent in sleep stages

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

change from baseline, descriptive

Secondary/protocol endpoint

Change in sleep continuity

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

change from baseline, improvement

Other/protocol endpoint

Change in cravings

Time frame:Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)

AUDIT score

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in health conditions

Time frame:Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)

descriptive

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Change in medications

Time frame:Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)

descriptive

Other/protocol endpoint/low confidence

Program Engagement

Time frame:Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)

event count, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.