GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study (FLOURISH)
2026년 5월 8일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
2310
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Erin C Owen, PhD, MPH
- 전화번호: (929)-644-7193
- 이메일: erin.owen@noom.com
연구 연락처 백업
- 이름: Marielle Darwin, PhD
- 전화번호: (929)-644-7193
- 이메일: marielle.darwin@noom.com
연구 장소
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New Jersey
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Princeton, New Jersey, 미국, 08542
- Noom, Inc.
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연락하다:
- Marielle Darwin, PhD
- 전화번호: (929)-644-7193
- 이메일: marielle.darwin@noom.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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).
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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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.
다른 이름들:
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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.
다른 이름들:
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Weight
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in heart rate variability (HRV)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depression symptoms
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Erin C Owen, PhD, MPH, Noom Inc.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 4월 30일
기본 완료 (추정된)
2029년 5월 1일
연구 완료 (추정된)
2029년 5월 1일
연구 등록 날짜
최초 제출
2026년 4월 30일
QC 기준을 충족하는 최초 제출
2026년 5월 8일
처음 게시됨 (실제)
2026년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 8일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RX6014: FLOURISH and THRIVE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .