Not_yet_recruitingNCT07588984

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

Sponsor: Noom Inc.

Trial Details

ConditionObesity & Overweight, Weight Loss, Preventative Health, Body Weight, Cardiovascular Disease Risk Factor
InterventionNoom Weight; Free Tier; Education-only control; Semaglutide; Tirzepatide; Microdose semaglutide; Microdose tirzepatide
StatusNot_yet_recruiting
Participants2,310
Est. Completion1 May 2029
Last Updated15 May 2026

Primary Outcome

Change in Body Weight; Change in fasting glucose; Change in HbA1c; Change in LDL cholesterol; Change in HDL cholesterol; Change in total cholesterol; Change in triglycerides; Change in Body Composition; GLP-1 Side Effect Profile

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United States
View Registry Entry

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