Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07588984

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Weight Loss, Preventative Health, Body Weight, Cardiovascular Disease Risk Factor

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Change in Body WeightMonthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)

Change from baseline in body weight (kg/lbs) measured via connected scale.

Change in fasting glucoseBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Change in HbA1cBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.

Change in LDL cholesterolBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Change in HDL cholesterolBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Change in total cholesterolBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Change in triglyceridesBaseline, Month 2, Month 4, Month 8, Month 12

Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Change in Body CompositionMonthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)

Change from baseline in estimated body composition metrics (lean mass, fat mass percentage) as measured via in-app BodyScan feature.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Noom, Inc.🇺🇸 Princeton, New Jersey, United States

Open map

Marielle Darwin, PhDContact

Email · Call (929)-644-7193