Body Weight, Cardiovascular Disease Risk Factor, Obesity & Overweight, Preventative Health, Weight Loss
Conditions
Keywords
GLP-1, Microdose, weight, body composition, metabolic, biomarkers, longevity, glucagon-like peptide-1, semaglutide, tirzepatide, microdosing, digital health, weight loss, behavioral health, real world evidence
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.
Detailed description
FLOURISH (Functional Longitudinal Outcomes Under Repeated Intentional Small Habits) and THRIVE (Trajectories of Health, Resilience & Integrated Vitality Evaluation) are designed to evaluate whether GLP-1 medications paired with a behavioral health digital companion delivered via the Noom application produce clinically meaningful improvements in weight, cardiometabolic biomarkers, physiological indicators, and patient-reported outcomes. All programs are commercially available Noom offerings. Research activities supplement but do not alter standard program care. Participants are recruited from active program users after program enrollment (GLP-1 programs, Noom Weight, Free Tier arms) or via an electronic recruitment platform (Education-only control). Measurement occurs at baseline and monthly through month 12, with additional follow-ups at months 18 and 24 for GLP-1 arms. Biomarker collection uses the FDA-cleared Tasso+ capillary blood device at baseline and months 2, 4, 8, and 12. Connected scales provide monthly weight data. Wearable fitness trackers (arm-specific) provide continuous physiological data including resting heart rate, HRV, SpO2, and sleep. In-app BodyScan and FaceScan capture body composition and HRV estimates monthly. Self-report measures assess depression (PHQ-8), anxiety (GAD-7), sleep (PROMIS Sleep Disturbance), vitality (Subjective Vitality Scale), health-related quality of life (PROMIS PROPr), flourishing (PERMA), appetite and food cravings (Mind-Eat, Food Noise Questionnaire, PACS), and GLP-1 side effects and medication adherence. Conflict of interest: Noom, Inc. is both sponsor and developer of the interventions under study. This is disclosed to all participants and will be reported in publications.
Interventions
BEHAVIORALNoom Weight
App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
BEHAVIORALFree Tier
Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
BEHAVIORALEducation-only control
Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
DRUGSemaglutide
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.
DRUGTirzepatide
Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
DRUGMicrodose 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.
DRUGMicrodose tirzepatide
Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
Sponsors
Noom Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Monthly, 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 glucose | Baseline, 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 HbA1c | Baseline, 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 cholesterol | Baseline, 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 cholesterol | Baseline, 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 cholesterol | Baseline, 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 triglycerides | Baseline, 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 Composition | Monthly, 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. |
| GLP-1 Side Effect Profile | Baseline (pre-treatment), Monthly through Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 heart rate variability (HRV) from baseline measured via in-app FaceScan feature (all arms) and wearables (select arms). |
| 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 resting heart rate (RHR) from baseline measured via wearables (select arms). |
| 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 Peripheral Capillary Oxygen Saturation (SpO2) from baseline measured via wearables (select arms). |
| 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 sleep duration (hours and minutes) from baseline measured via wearables (select arms). |
| 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. | Change in time spent in sleep stages (hours and minutes spent in each sleep stage) from baseline measured via wearables (select arms). |
| Change in sleep continuity | Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program. | Change from baseline in wearable-derived sleep continuity, assessed as sleep onset latency (SOL) and wake after sleep onset (WASO), measured in minutes. |
Countries
United States
Contacts
CONTACTErin C Owen, PhD, MPH
CONTACTMarielle Darwin, PhD
PRINCIPAL_INVESTIGATORErin C Owen, PhD, MPH
Noom Inc.
Outcome results
None listed