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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Noom Inc.
- 入组人数
- 2,310
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Microdose tirzepatide (Drug)
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.
干预措施: Free Tier (Behavioral)
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.
干预措施: Tirzepatide (Drug)
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.
干预措施: Microdose semaglutide (Drug)
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.
干预措施: Education-only control (Behavioral)
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.
干预措施: Noom Weight (Behavioral)
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.
干预措施: Microdose semaglutide (Drug)
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.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: 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.
Change in fasting glucose
时间窗: 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.
Change in HbA1c
时间窗: 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.
Change in LDL cholesterol
时间窗: 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.
Change in HDL cholesterol
时间窗: 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.
Change in total cholesterol
时间窗: 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.
Change in triglycerides
时间窗: 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.
Change in Body Composition
时间窗: 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.
GLP-1 Side Effect Profile
时间窗: 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.
次要结局
- Change in heart rate variability (HRV)(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)(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)(Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.)
- Change in sleep duration(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(Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.)
- Change in sleep continuity(Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.)