GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study (FLOURISH)
8. května 2026 aktualizováno: Noom Inc.
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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
2310
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Erin C Owen, PhD, MPH
- Telefonní číslo: (929)-644-7193
- E-mail: erin.owen@noom.com
Studijní záloha kontaktů
- Jméno: Marielle Darwin, PhD
- Telefonní číslo: (929)-644-7193
- E-mail: marielle.darwin@noom.com
Studijní místa
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New Jersey
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Princeton, New Jersey, Spojené státy, 08542
- Noom, Inc.
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Kontakt:
- Marielle Darwin, PhD
- Telefonní číslo: (929)-644-7193
- E-mail: marielle.darwin@noom.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
The study population includes individuals enrolled in Noom commercially available programs and individuals interested in weight loss not enrolled in a weight management program (education-only control group).
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Education only (control)
Arm 1 of FLOURISH: This is an active control condition in which participants will receive weekly informational newsletters for 12 months.
This group will not have access to the Noom app (except for research purposes) and will not receive GLP-1 medications.
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Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
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Noom Weight
Arm 2 of FLOURISH: Noom Weight users will have access to all in-app features.
This group will not receive GLP-1 medications.
Followed for 12 months.
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App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
Ostatní jména:
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Standard GLP-1Rx
Arm 3 of FLOURISH: Standard GLP-1 users will follow a protocol for Noom's standard dose of compounded semaglutide and will have access to all in-app features.
Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
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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.
Ostatní jména:
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Microdose GLP-1Rx
Arm 4 of FLOURISH: Microdose GLP-1 users will follow a microdose protocol of compounded semaglutide and will have access to all in-app features.
Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
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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.
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Noom Plus
Arm 5 of FLOURISH: Participants will follow a protocol for Noom's standard dose of compounded tirzepatide and will have access to all in-app features.
Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
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Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
Ostatní jména:
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Noom Plus Microdose
Arm 6 of FLOURISH: Noom Plus Microdose users will follow a microdose protocol for compounded tirzepatide and will have access to all in-app features.
Followed for up to 12 months of program with 18 and 24 month follow-up post-GLP-1 discontinuation.
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Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
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Noom Free Tier (control)
Arm 1 of THRIVE: This is an active control condition in which users enrolled in Noom's Free Tier program will have access to app features available to Free Tier.
This group will not receive GLP-1 medications.
Followed for 12 months.
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Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
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Proactive Health
Arm 2 of THRIVE: Proactive health users will follow the microdose protocol for compounded semaglutide indicated for preventive health/longevity.
They will have access to all in-app features.
Followed for 12 months.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Body Weight
Časové okno: Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
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Change from baseline in body weight (kg/lbs) measured via connected scale.
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Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
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Change in fasting glucose
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in HbA1c
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in LDL cholesterol
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in HDL cholesterol
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in total cholesterol
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in triglycerides
Časové okno: Baseline, Month 2, Month 4, Month 8, Month 12
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Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
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Baseline, Month 2, Month 4, Month 8, Month 12
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Change in Body Composition
Časové okno: Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)
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Change from baseline in estimated body composition metrics (lean mass, fat mass percentage) as measured via in-app BodyScan feature.
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Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)
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GLP-1 Side Effect Profile
Časové okno: Baseline (pre-treatment), Monthly through Month 12
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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.
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Baseline (pre-treatment), Monthly through Month 12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in heart rate variability (HRV)
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in heart rate variability (HRV) from baseline measured via in-app FaceScan feature (all arms) and wearables (select arms).
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in resting heart rate (RHR)
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in resting heart rate (RHR) from baseline measured via wearables (select arms).
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in Peripheral Capillary Oxygen Saturation (SpO2)
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in Peripheral Capillary Oxygen Saturation (SpO2) from baseline measured via wearables (select arms).
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in sleep duration
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in sleep duration (hours and minutes) from baseline measured via wearables (select arms).
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in time spent in sleep stages
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in time spent in sleep stages (hours and minutes spent in each sleep stage) from baseline measured via wearables (select arms).
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change in sleep continuity
Časové okno: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Change from baseline in wearable-derived sleep continuity, assessed as sleep onset latency (SOL) and wake after sleep onset (WASO), measured in minutes.
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Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Depression symptoms
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Anxiety symptoms
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Sleep disturbance
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Energy and Vitality
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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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)
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Health-related quality of life (HRQoL)
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Flourishing & Wellbeing
Časové okno: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Change from baseline on PERMA questionnaire total and subscale scores.
Scores on each of the 5 subscales range from 0-10, with lower scores indicating significant challenges in that domain and higher scores indicating that domain is a strong source of wellbeing.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Change in appetite
Časové okno: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change from baseline on Mind-Eat Scale.
Minimum score = 24 maximum score = 120.
Lower scores = low mindful eating; higher scores = highly mindful eating.
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Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change in food noise
Časové okno: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change from baseline on Food Noise Questionnaire.
Minimum score = 0 maximum score = 20.
Lower scores = low food noise higher scores = high food noise/preoccupation
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Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change in cravings
Časové okno: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change from baseline on Penn Alcohol Cravings Scale.
Minimum score = 0 maximum score = 30.
Lower scores = no craving; high scores = severe craving.
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Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
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Change in health conditions
Časové okno: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Changes in health conditions will be assessed via self-report items related to presence of new health condition(s) and changes in pre-existing health conditions.
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Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Change in medications
Časové okno: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Change in medications will be assessed via self-report items related to users starting new medications, stopping previous medications, and/or dose changes in medications.
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Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Adverse event reporting
Časové okno: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Adverse events will be assessed by self-reported hospitalizations and urgent care visits, type of care received during visits, complications/functional impairment related to adverse event(s), and resolution of adverse event(s).
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Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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GLP-1 discontinuation measure
Časové okno: Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)
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GLP-1 Treatment Continuation and Discontinuation Self-Efficacy surveys will assess participants' weight goals, confidence in meeting goals and self-efficacy related to skills and behaviors important to weight management after GLP-1 discontinuation.
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Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)
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Program Engagement
Časové okno: Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Number of participant in-app actions (e.g., what type of app clicks occur within the application user interface), rolled up by count per day within each action type: medication adherence, nutrition, physical activity, shaping knowledge, accountability, health assessment, social, and mood-boosting.
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Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Erin C Owen, PhD, MPH, Noom Inc.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. dubna 2026
Primární dokončení (Odhadovaný)
1. května 2029
Dokončení studie (Odhadovaný)
1. května 2029
Termíny zápisu do studia
První předloženo
30. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
8. května 2026
První zveřejněno (Aktuální)
15. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Poruchy výživy
- Nadměrná výživa
- Změny tělesné hmotnosti
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Nadváha
- Obezita
- Ztráta váhy
- Tělesná hmotnost
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Glukagonský peptid-1 receptor
- Glukagonové peptidové receptory
- Receptory, G-protein-spojené
- Receptory, buněčný povrch
- Membránové proteiny
- Receptory, gastrointestinální hormon
- Receptory, peptid
- Tirzepatid
- Semaglutid
Další identifikační čísla studie
- RX6014: FLOURISH and THRIVE
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .