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NCT Number: NCT07588984

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

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Key information

Conditions

Obesity & Overweight Body Weight Body Weight Changes Cardiovascular Disease Risk Factor Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Preventative Health Signs and Symptoms Weight Loss

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noom Weight

Behavioral

App-based behavioral weight management program providing structured educational content, coaching, and self-monitoring tools focused on nutrition, physical activity, and habit formation.

Other names: Noom

Free Tier

Behavioral

Basic free-to-use tier of the Noom app with limited features; no structured behavioral program or medication.

Education-only Control

Behavioral

Weekly informational newsletters based on the CDC curriculum for 12 months; no structured behavioral program or medication.

semaglutide

Drug

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.

Other names: Noom standard dose semaglutide

Tirzepatide

Drug

Standard clinical dosing of tirzepatide as part of Noom Plus program per clinical standard of care, combined with enhanced behavioral coaching.

Other names: Noom standard dose tirzepatide

Microdose semaglutide

Drug

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.

Microdose tirzepatide

Drug

Below-standard clinical dosing (microdose) of tirzepatide as part of Noom Plus Microdose program, combined with enhanced behavioral coaching.

Primary outcomes

  1. Change in Body Weight

    Time frame: 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.

  2. Change in fasting glucose

    Time frame: 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.

  3. Change in HbA1c

    Time frame: 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.

  4. Change in LDL cholesterol

    Time frame: 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.

  5. Change in HDL cholesterol

    Time frame: 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.

  6. Change in total cholesterol

    Time frame: 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.

  7. Change in triglycerides

    Time frame: 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.

  8. Change in Body Composition

    Time frame: 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.

  9. GLP-1 Side Effect Profile

    Time frame: 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.

Secondary outcomes

  1. Change in heart rate variability (HRV)

    Time frame: 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).

  2. Change in resting heart rate (RHR)

    Time frame: 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).

  3. Change in Peripheral Capillary Oxygen Saturation (SpO2)

    Time frame: 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).

  4. Change in sleep duration

    Time frame: 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).

  5. Change in time spent in sleep stages

    Time frame: 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).

  6. Change in sleep continuity

    Time frame: 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.

Other outcomes

  1. Depression symptoms

    Time frame: 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.

  2. Anxiety symptoms

    Time frame: 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.

  3. Sleep disturbance

    Time frame: 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.

  4. Energy and Vitality

    Time frame: 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)

  5. Health-related quality of life (HRQoL)

    Time frame: 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.

  6. Flourishing & Wellbeing

    Time frame: 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.

  7. Change in appetite

    Time frame: 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.

  8. Change in food noise

    Time frame: 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

  9. Change in cravings

    Time frame: 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.

  10. Change in health conditions

    Time frame: 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.

  11. Change in medications

    Time frame: 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.

  12. Adverse event reporting

    Time frame: 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).

  13. GLP-1 discontinuation measure

    Time frame: 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.

  14. Program Engagement

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin C Owen, PhD, MPH

CONTACT

[email protected]

(929)-644-7193

Marielle Darwin, PhD

CONTACT

[email protected]

(929)-644-7193

Sponsors and collaborators

Lead sponsor

Noom Inc.

Industry

Registry information

Official study title

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

Acronym: FLOURISH

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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