Noom Health for Weight Management

NCT04797169 | Completed Results

• 1 other identifier: GCO 20-2224
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss; Obesity

Keywords

Weight Loss; Mobile App; Digital Health; Weight Loss Maintenance; Weight Loss Suppression; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Weight From Baseline

  Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.

  Baseline, 6 months and 30 Months

Secondary Outcomes (14)

• Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months

  Baseline and 30 Months

• Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months

  Baseline and 30 Months

• Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months

  Baseline and 30 Months

• Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months

  Baseline and 30 Months

• Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months

  Baseline and 30 Months

Study Arms (2)

Noom Health

EXPERIMENTAL

Behavioral: Noom Health

Noom Digital Health

ACTIVE COMPARATOR

Behavioral: Noom Digital Health

Interventions

Noom Health BEHAVIORAL

In Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.

Noom Health

Noom Digital Health BEHAVIORAL

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.

Noom Digital Health

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Noom Inc.: collaborator

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10028, United States

Location

Related Publications (1)

• Sysko R, Bibeau J, Boyar A, Costello K, Michaelides A, Mitchell ES, Susanin A, Hildebrandt T. A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.

  PMID: 35969439 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Thomas B Hildebrandt, Psy.D.
• Organization: Icahn School of Medicine at Mount Sinai

tom.hildebrandt@mssm.edu

(212) 659-8673

Study Officials

• Thomas Hildebrandt, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chief of the Division of Eating & Weight Disorders

Model Details: Participants will be randomized to one of two conditions in a parallel design including a 12-month intervention. Participants will be openly-enrolled over the course of 12-months until the recruitment goal of 600, 300 in each group, is reached.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 22, 2021
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)