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

ConditionsObesity & OverweightWeight LossPreventative HealthBody WeightCardiovascular Disease Risk Factor
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorNoom Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

  • Tirzepatide

    Drug

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

  • 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.

Treatment groups

2,310 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Education only (control)1 intervention
Group B: Noom Weight1 intervention
Group C: Standard GLP-1Rx1 intervention
Group D: Microdose GLP-1Rx1 intervention
Group E: Noom Plus1 intervention
Group F: Noom Plus Microdose1 intervention
Group G: Noom Free Tier (control)1 intervention
Group H: Proactive Health1 intervention

Trial outcomes

Primary outcomes

1

Change in Body Weight

Change from baseline in body weight (kg/lbs) measured via connected scale.

Time frame
Monthly, Baseline through Month 12 (and Months 18 & 24 for FLOURISH GLP-1 arms)
2

Change in fasting glucose

Change from baseline in fasting glucose (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Time frame
Baseline, Month 2, Month 4, Month 8, Month 12
3

Change in HbA1c

Change from baseline in HbA1c (mmol/mol and percentage) measured via Tasso+ capillary blood collection device.

Time frame
Baseline, Month 2, Month 4, Month 8, Month 12
4

Change in LDL cholesterol

Change from baseline in LDL cholesterol (milligrams per deciliter (mg/dL)) measured via Tasso+ capillary blood collection device.

Time frame
Baseline, Month 2, Month 4, Month 8, Month 12

Secondary outcomes

1

Change in heart rate variability (HRV)

Change in heart rate variability (HRV) from baseline measured via in-app FaceScan feature (all arms) and wearables (select arms).

Time frame
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
2

Change in resting heart rate (RHR)

Change in resting heart rate (RHR) from baseline measured via wearables (select arms).

Time frame
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
3

Change in Peripheral Capillary Oxygen Saturation (SpO2)

Change in Peripheral Capillary Oxygen Saturation (SpO2) from baseline measured via wearables (select arms).

Time frame
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.
4

Change in sleep duration

Change in sleep duration (hours and minutes) from baseline measured via wearables (select arms).

Time frame
Collected monthly from baseline through month 12 and at months 18 and 24 for the FLOURISH GLP-1 program.

Other outcomes

1

Depression symptoms

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.

Time frame
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
2

Anxiety symptoms

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.

Time frame
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
3

Sleep disturbance

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.

Time frame
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)
4

Energy and Vitality

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)

Time frame
Baseline, Months 4, 8, 12 (and 18, 24 for FLOURISH GLP-1 arms)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Noom Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: