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Trial · NCT07588984

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange 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.
PrimaryChange in fasting glucoseBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
PrimaryChange in HbA1cBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.
PrimaryChange in LDL cholesterolBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
PrimaryChange in HDL cholesterolBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
PrimaryChange in total cholesterolBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
PrimaryChange in triglyceridesBaseline, Month 2, Month 4, Month 8, Month 12Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
PrimaryChange 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.
PrimaryGLP-1 Side Effect ProfileBaseline (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.
SecondaryChange 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).
SecondaryChange 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).
SecondaryChange 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).
SecondaryChange in sleep durationCollected 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).
SecondaryChange in time spent in sleep stagesCollected 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).
SecondaryChange in sleep continuityCollected 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.
OtherDepression symptomsBaseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)Change from baseline in Patient Health Questionnaire-8 (PHQ-8) score. Minimum score = 0; maximum score = 24. Lower score indicate none/mild depression; higher scores indicate severe depression.
OtherAnxiety symptomsBaseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score. Minimum score = 0; maximum score = 21. Lower scores = minimal or no anxiety; higher scores = severe anxiety.
OtherSleep disturbanceBaseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8-item scale. Minimum score = 8; maximum score = 40. Lower scores = minimal or no sleep disturbance; higher scores = severe sleep disturbance.
OtherEnergy and VitalityBaseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Change from baseline on Subjective Vitality Scale. Minimum score = 6; maximum score = 42. Lower scores = worse outcome (lower energy and vitality); higher scores = better outcome (more energy and vitality)
OtherHealth-related quality of life (HRQoL)Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)Change from baseline on PROMIS PROPr composite score. Minimum score = -.022; maximum score = 1. Lower scores = worse outcome/health status ; higher scores = optimal health-related quality of life.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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