GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study (FLOURISH)
8 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
2310
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Erin C Owen, PhD, MPH
- Número de teléfono: (929)-644-7193
- Correo electrónico: erin.owen@noom.com
Copia de seguridad de contactos de estudio
- Nombre: Marielle Darwin, PhD
- Número de teléfono: (929)-644-7193
- Correo electrónico: marielle.darwin@noom.com
Ubicaciones de estudio
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New Jersey
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Princeton, New Jersey, Estados Unidos, 08542
- Noom, Inc.
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Contacto:
- Marielle Darwin, PhD
- Número de teléfono: (929)-644-7193
- Correo electrónico: marielle.darwin@noom.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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).
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
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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.
Otros nombres:
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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.
Otros nombres:
|
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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.
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body Weight
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in heart rate variability (HRV)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression symptoms
Periodo de tiempo: Baseline, 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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
|
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Anxiety symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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Flourishing & Wellbeing
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
|
Change from baseline on Food Noise Questionnaire.
Minimum score = 0 maximum score = 20.
Lower scores = low food noise higher scores = high food noise/preoccupation
|
Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
|
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Change in cravings
Periodo de tiempo: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
|
Change from baseline on Penn Alcohol Cravings Scale.
Minimum score = 0 maximum score = 30.
Lower scores = no craving; high scores = severe craving.
|
Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
|
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Change in health conditions
Periodo de tiempo: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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.
|
Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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Change in medications
Periodo de tiempo: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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.
|
Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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Adverse event reporting
Periodo de tiempo: Baseline and monthly through month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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).
|
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
Periodo de tiempo: Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)
|
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.
|
Monthly through Month 12; follow-up (and at Months 18 and 24 for FLOURISH GLP-1 arms)
|
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Program Engagement
Periodo de tiempo: Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
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.
|
Monthly, Baseline through Month 12 (and at 18 and 24 months for FLOURISH GLP-1 arms)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Erin C Owen, PhD, MPH, Noom Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de abril de 2026
Finalización primaria (Estimado)
1 de mayo de 2029
Finalización del estudio (Estimado)
1 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Cambios en el peso corporal
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Pérdida de peso
- Peso corporal
- Aminoácidos, péptidos y proteínas
- Proteínas
- Receptor de péptido-1 tipo glucagón
- Receptores de péptidos tipo glucagón
- Receptores, acoplados a la proteína G
- Receptores, superficie celular
- Proteínas de membrana
- Receptores, hormona gastrointestinal
- Receptores, péptido
- Tirzepatide
- semaglutida
Otros números de identificación del estudio
- RX6014: FLOURISH and THRIVE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .