Coached or Non-Coached Weight Loss Intervention

Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention

To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Overweight and Obesity; Self Efficacy; Behavior, Health; Behavior, Eating
• Intervention / Treatment: Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching; Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Noom, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand and provide informed consent
• 18-65 years old
• Self-report of good health (physical and mental)
• Not diagnosed with diabetes
• Overweight or obesity (BMI ≥ 27)
• Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
• Not 6 months postpartum
• Not planning to become pregnant in the next 5 months.

Exclusion Criteria:

• Inability or unwillingness of a participant to give written informed consent
• Currently pregnant or ≤ 6 months postpartum
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., evidence of an eating disorder, major chronic condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coached	Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching; The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach. Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.
Active Comparator: No Coach	Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss; The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity. During the first week of the study, participants will be introduced to the program, and the Noom app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Self reported	4 months
Self reported in app engagement measures	self reported and automatically logged	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Via SF-12	Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure	4 months
Eating Behavior via the Dutch Eating Behavior Questionnaire	The Dutch Eating Behavior Questionnaire (DEBQ) assesses the structure of an individual's eating behavior. the DEBQ contains separate scales for emotional, external, and restrained eating behavior.	4 months
Resilience via Devereux Adult Resilience Survey	Provides insights into personal strengths	4 months
Self Efficacy via General Self-Efficacy Scale	The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.	4 months
Linguistic Features via Linguistic Inquiry Word Count (LIWC)	LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt	16 weeks

Collaborators and Investigators

• Sponsor: Noom Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 00046922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No