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GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study (FLOURISH)

8. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

2310

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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).

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Verhalten: Education-only control
Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
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.
Verhalten: Noom Weight
App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.
Andere Namen:
  • Noom
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.
Arzneimittel: Semaglutide
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.
Andere Namen:
  • Noom standard dose semaglutide
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.
Arzneimittel: Microdose semaglutide
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.
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.
Arzneimittel: Tirzepatide
Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
Andere Namen:
  • Noom standard dose tirzepatide
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.
Arzneimittel: Microdose tirzepatide
Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.
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.
Verhalten: Free Tier
Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
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.
Arzneimittel: Microdose semaglutide
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Weight
Zeitfenster: Monthly, 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.
Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
Change in fasting glucose
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in HbA1c
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in LDL cholesterol
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in HDL cholesterol
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in HDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in total cholesterol
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in total cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in triglycerides
Zeitfenster: Baseline, Month 2, Month 4, Month 8, Month 12
Change from baseline in triglycerides (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.
Baseline, Month 2, Month 4, Month 8, Month 12
Change in Body Composition
Zeitfenster: Monthly, 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.
Monthly, Baseline through Month 12 ((and Months 18 & 24 for FLOURISH GLP-1 arms)
GLP-1 Side Effect Profile
Zeitfenster: Baseline (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.
Baseline (pre-treatment), Monthly through Month 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in heart rate variability (HRV)
Zeitfenster: 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).
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)
Zeitfenster: 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).
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)
Zeitfenster: 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).
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in sleep duration
Zeitfenster: Collected 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).
Collected 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
Zeitfenster: Collected 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).
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
Change in sleep continuity
Zeitfenster: Collected 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.
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depression symptoms
Zeitfenster: 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.
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Anxiety symptoms
Zeitfenster: Baseline, 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.
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Sleep disturbance
Zeitfenster: Baseline, 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.
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Energy and Vitality
Zeitfenster: Baseline, 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)
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Health-related quality of life (HRQoL)
Zeitfenster: 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.
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Flourishing & Wellbeing
Zeitfenster: Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
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.
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
Change in appetite
Zeitfenster: Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
Change from baseline on Mind-Eat Scale. Minimum score = 24 maximum score = 120. Lower scores = low mindful eating; higher scores = highly mindful eating.
Baseline, months 4, 8, 12 (and 18, 24 for GLP-1 arms)
Change in food noise
Zeitfenster: 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)
Change in cravings
Zeitfenster: 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)
Change in health conditions
Zeitfenster: 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)
Change in medications
Zeitfenster: 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)
Adverse event reporting
Zeitfenster: 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)
GLP-1 discontinuation measure
Zeitfenster: 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)
Program Engagement
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Noom Inc.

Ermittler

  • Hauptermittler: Erin C Owen, PhD, MPH, Noom Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. April 2026

Primärer Abschluss (Geschätzt)

1. Mai 2029

Studienabschluss (Geschätzt)

1. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RX6014: FLOURISH and THRIVE

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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Produkt, das in den USA hergestellt und aus den USA exportiert wird

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