GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study
FLOURISH
1 other identifier
observational
2,310
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
May 15, 2026
May 1, 2026
3 years
April 30, 2026
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Change in Body Weight
Change from baseline in body weight (kg/lbs) measured via connected scale.
Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
Change in fasting glucose
Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in HbA1c
Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in LDL cholesterol
Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in HDL cholesterol
Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in total cholesterol
Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in triglycerides
Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in Body Composition
Change from baseline in estimated body composition metrics (lean mass, fat mass percentage) as measured via in-app BodyScan feature.
Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)
GLP-1 Side Effect Profile
Number, severity, and tolerance of GLP-1 medication-related side effects (nausea, vomiting, diarrhea, constipation, headache, fatigue, injection site reactions) assessed via monthly self-report. Applicable to GLP-1 arms only.
Baseline (pre-treatment), Monthly through Month 12
Secondary Outcomes (6)
Change in heart rate variability (HRV)
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in resting heart rate (RHR)
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in Peripheral Capillary Oxygen Saturation (SpO2)
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in sleep duration
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in time spent in sleep stages
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
- +1 more secondary outcomes
Other Outcomes (14)
Depression symptoms
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Anxiety symptoms
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Sleep disturbance
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
- +11 more other outcomes
Study Arms (8)
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
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.
Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
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.
Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noom Inc.lead
Study Sites (1)
Noom, Inc.
Princeton, New Jersey, 08542, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin C Owen, PhD, MPH
Noom Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2026
First Posted
May 15, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share