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Noom Health for Weight Management

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Weight Loss
Obesity

Treatments

Behavioral: Noom Health
Behavioral: Noom Digital Health

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04797169
GCO 20-2224

Details and patient eligibility

About

The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.

Full description

A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.

Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).

In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.

During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).

Enrollment

600 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants must be interested in the Noom app
  • BMI > 27 kg/m2
  • Ages of 18 and 60 at entry to the study
  • Speak English

Exclusion criteria

  • Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)
  • Acute suicide risk
  • Pregnant or planning to become pregnant during the study
  • Current Noom use

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

Noom Health
Experimental group
Treatment:
Behavioral: Noom Health
Noom Digital Health
Active Comparator group
Treatment:
Behavioral: Noom Digital Health

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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