Back to resultsCoached or Non-Coached Weight Loss Intervention
Primary Purpose
Obesity, Behavior, Health, Behavior, Eating
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching
Noom Healthy Weight; mobile behavior change program for weight loss
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Noom, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coached
No Coach
Arm Description
Outcomes
Primary Outcome Measures
Weight
Self reported
Self reported in app engagement measures
self reported and automatically logged
Secondary Outcome Measures
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
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.
Resilience via Devereux Adult Resilience Survey
Provides insights into personal strengths
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04645108
Brief Title
Coached or Non-Coached Weight Loss Intervention
Official Title
Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Behavior, Health, Behavior, Eating, Weight Loss, Overweight and Obesity, Self Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coached
Arm Type
Experimental
Arm Title
No Coach
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight; mobile behavior change program for weight loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Self reported
Time Frame
4 months
Title
Self reported in app engagement measures
Description
self reported and automatically logged
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of Life Via SF-12
Description
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
Time Frame
4 months
Title
Eating Behavior via the Dutch Eating Behavior Questionnaire
Description
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.
Time Frame
4 months
Title
Resilience via Devereux Adult Resilience Survey
Description
Provides insights into personal strengths
Time Frame
4 months
Title
Self Efficacy via General Self-Efficacy Scale
Description
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.
Time Frame
4 months
Title
Linguistic Features via Linguistic Inquiry Word Count (LIWC)
Description
LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Noom, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coached or Non-Coached Weight Loss Intervention
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