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

GLP-1 Medication & Behavioral Health on Weight and Metabolic Outcomes: FLOURISH (Functional Longitudinal Outcomes Under Intentional Small Habits) & THRIVE (Trajectories of Health, Resilience & Integrated Vitality Evaluation) Cohort Study

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.

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.

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