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

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
Noom Inc.
Study ID
NCT07588984
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Noom Weight — BEHAVIORAL
    App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
  • Free Tier — BEHAVIORAL
    Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
  • Education-only control — BEHAVIORAL
    Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
  • Semaglutide — 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.
  • Tirzepatide — DRUG
    Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
  • Microdose semaglutide — DRUG
    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 tirzepatide — DRUG
    Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
2,310 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Noom Weight
    Arm 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.
  • Arm: Standard GLP-1Rx
    Arm 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.
  • Arm: Microdose GLP-1Rx
    Arm 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.
  • Arm: Noom Plus
    Arm 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.
  • Arm: Noom Plus Microdose
    Arm 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.
  • Arm: 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.
  • Arm: Proactive Health
    Arm 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.

Primary Outcome Measure

Change in Body Weight [ Time Frame: Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Noom, Inc.PrincetonNew Jersey08542
Marielle Darwin, PhD
[email protected]
(929)-644-7193

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