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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Free Tier
  Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.
• Поведенческое Education-only control
  Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.
• Препарат 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.
• Препарат Tirzepatide
  Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
• Препарат 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.
• Препарат Microdose tirzepatide
  Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Change in heart rate variability (HRV) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.]
• Change in sleep duration [Срок оценки: 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 [Срок оценки: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.]
• Change in sleep continuity [Срок оценки: Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Noom, Inc. — Princeton

Идентификаторы

NCT: NCT07588984 · RX6014: FLOURISH and THRIVE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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