GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study
NCT07588984 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2310
Last updated 2026-05-15
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.
Conditions
- Obesity & Overweight
- Weight Loss
- Preventative Health
- Body Weight
- Cardiovascular Disease Risk Factor
Interventions
- DRUG
-
Microdose tirzepatide
Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
- BEHAVIORAL
-
Education-only control
Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
- DRUG
-
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
-
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.
- 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.
Sponsors & Collaborators
-
Noom Inc.
lead INDUSTRY
Principal Investigators
-
Erin C Owen, PhD, MPH · Noom Inc.
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2029-05-31
- Completion
- 2029-05-31
Countries
- United States
Study Locations
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