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

No results posted yet for this study

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

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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07588984 on ClinicalTrials.gov