このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年5月8日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

2310

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Erin C Owen, PhD, MPH
  • 電話番号：(929)-644-7193
  • メール：erin.owen@noom.com

研究連絡先のバックアップ

研究場所

  • アメリカ
    • New Jersey
      • Princeton、New Jersey、アメリカ、08542

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
行動：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.
行動：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.
他の名前：
  • 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.
薬：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.
他の名前：
  • 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.
薬：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.
薬：Tirzepatide
Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.
他の名前：
  • 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.
薬：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.
行動：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Body Weight
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in heart rate variability (HRV)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Depression symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Noom Inc.

捜査官

  • 主任研究者：Erin C Owen, PhD, MPH、Noom Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年4月30日

一次修了 (推定)

2029年5月1日

研究の完了 (推定)

2029年5月1日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RX6014: FLOURISH and THRIVE

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する