Coached or Non-Coached Weight Loss Intervention

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645108
• Other study ID #: 00046922
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: October 2022
• Source: Noom Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Eating
• Behavior, Health
• Body Weight
• Obesity
• Overweight
• Overweight and Obesity
• Self Efficacy
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Noom, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Self reported	4 months
Primary	Self reported in app engagement measures	self reported and automatically logged	4 months
Secondary	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
Secondary	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
Secondary	Resilience via Devereux Adult Resilience Survey	Provides insights into personal strengths	4 months
Secondary	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
Secondary	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