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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04645108
Other study ID # 00046922
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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