Study S000529

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

ClinicalTrials.gov record

Registration

Registration: NCT07588984
Acronym: FLOURISH
Study type: OBSERVATIONAL
Status: NOT_YET_RECRUITING
Enrollment: 2310
Start: 2026-04-30
Primary completion: 2029-05
Lead sponsor: Noom Inc.
Conditions: Obesity & Overweight; Weight Loss; Preventative Health; Body Weight; Cardiovascular Disease Risk Factor
Interventions: BEHAVIORAL:Noom Weight; BEHAVIORAL:Free Tier; BEHAVIORAL:Education-only control; DRUG:Semaglutide; DRUG:Tirzepatide; DRUG:Microdose semaglutide; DRUG:Microdose tirzepatide
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in Body Weight [Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)]
Change in fasting glucose [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in HbA1c [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in LDL cholesterol [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in HDL cholesterol [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in total cholesterol [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in triglycerides [Baseline, Month 2, Month 4, Month 8, Month 12]
Change in Body Composition [Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)]
GLP-1 Side Effect Profile [Baseline (pre-treatment), Monthly through Month 12]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.