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NCT07588984

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

Sponsor: Noom Inc.

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

OBSERVATIONAL

Enrollment

2310

Start Date

2026-04-30

Completion Date

2029-05

Last Updated

2026-05-15

Healthy Volunteers

Conditions

Obesity & Overweight Weight Loss Preventative Health Body Weight Cardiovascular Disease Risk Factor

Interventions

BEHAVIORAL

Noom Weight

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

BEHAVIORAL

Free Tier

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

BEHAVIORAL

Education-only control

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

DRUG

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.

DRUG

Tirzepatide

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

DRUG

Microdose semaglutide

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.

DRUG

Microdose tirzepatide

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

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

Locations (1)

Noom, Inc.

Princeton, New Jersey, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)