Noom Coach for Bariatric Surgery
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Coach for Bariatric Health
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring bariatric surgery, mobile health (mHealth), psychosocial functioning, obesity, weight loss, behavioral activation
Eligibility Criteria
Inclusion Criteria:
- Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
- Between the ages of 18 and 60 at entry to the study.
- Speak English.
Exclusion Criteria:
- Clinically significant cognitive limitations or history of developmental disability.
- History of neurological disorder or injury.
- Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
- Acute suicide risk.
- Current DSM-5 alcohol or substance use disorder.
- Pregnancy.
Sites / Locations
- Noom, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Noom Coach for Bariatric Health
Usual Care
Arm Description
Self-monitoring will be conducted through Noom Coach for Bariatric Health, and individuals will receive a specialized set of instructions on how to use the app.
The control group will be a "usual care" condition in which participants are free to seek any assistance for their bariatric surgery care during the study period.
Outcomes
Primary Outcome Measures
Change in adherence to dietary recommendations
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Change in adherence to physical activity recommendations (Activity Tracker)
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Change in adherence to physical activity recommendations (IPAQ)
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
Secondary Outcome Measures
Eating Disorder Examination Questionnaire (EDE-Q)
Change in EDE-Q at 8 weeks as compared to baseline. Questionnaire to assess for eating disorder symptomology. A 28 item measure with 4 subscales of restraint, eating concern, shape concern, and weight concern. Scores range from 0-168 with higher scores indicating more severe eating disorder pathology. Average scores on each subscale are used in addition to an average global score.
Depression Anxiety Stress Scales (DASS)
Change in symptoms of depression, anxiety, and stress at baseline and 8 weeks. A 42-item self-report questionnaire assessing three related negative emotional states: depression, anxiety, and stress. Items are scored on a 0-3 Likert scale with ranges within each emotional state for normal, mild, moderate, severe and extremely severe symptoms. Higher scores indicate more severe symptoms. Ranges in severity are reported as sum scores for each emotion state. Depression includes normal (0-9), mild (10-13), moderate (14-20), severe (21-27), extremely severe (28+). Anxiety includes normal (0-7), mild (8-9), moderate (10-14), severe (15-19) extremely severe (20+) Stress includes normal (0-14), mild (15-18) , moderate (19-25), severe (26-33) extremely severe (34+).
Short Form-36 Health Survey (SF-36)
The SF-36 is a 10-item self-report of health-related quality of life measure that generates eight scaled scored. Individual items are scored 0-100 with higher scores indicating a more favorable health state. The eight subscales, reported as weighted means as (0-100) for each scale, include physical functioning, bodily pain, role limitations due to physical health, role limitations due to personal and emotional problems, emotional well being, social functioning, energy/fatigue, general health perceptions.
Full Information
NCT ID
NCT03386006
First Posted
October 30, 2017
Last Updated
May 19, 2023
Sponsor
Noom Inc.
Collaborators
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03386006
Brief Title
Noom Coach for Bariatric Surgery
Official Title
Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.
Collaborators
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.
Detailed Description
Overweight and obesity have reached epidemic proportions in the United States. Few behavioral treatments are effective for overweight, and bariatric surgery is consequently an increasingly important option. Although these procedures produce significantly more weight change than psychosocial treatments, post-operative weight losses vary widely, about 20% of patients clearly experience suboptimal weight loss, and a notable subset of these patients demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the extent to which a person's behavior coincides with medical or health advice," contributes to variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines, each of which negatively impacts weight loss.
The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity to overcome obstacles to providing empirically supported treatments and to improve standard interventions utilized in bariatric surgery programs; however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. The project will therefore test a combined smartphone app and health coaching system to improve adherence and behavioral outcomes for patients receiving bariatric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
bariatric surgery, mobile health (mHealth), psychosocial functioning, obesity, weight loss, behavioral activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Noom Coach for Bariatric Health
Arm Type
Experimental
Arm Description
Self-monitoring will be conducted through Noom Coach for Bariatric Health, and individuals will receive a specialized set of instructions on how to use the app.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The control group will be a "usual care" condition in which participants are free to seek any assistance for their bariatric surgery care during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Noom Coach for Bariatric Health
Intervention Description
Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks.
Primary Outcome Measure Information:
Title
Change in adherence to dietary recommendations
Description
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Time Frame
Baseline and 8 weeks
Title
Change in adherence to physical activity recommendations (Activity Tracker)
Description
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Time Frame
Ongoing
Title
Change in adherence to physical activity recommendations (IPAQ)
Description
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
Change in EDE-Q at 8 weeks as compared to baseline. Questionnaire to assess for eating disorder symptomology. A 28 item measure with 4 subscales of restraint, eating concern, shape concern, and weight concern. Scores range from 0-168 with higher scores indicating more severe eating disorder pathology. Average scores on each subscale are used in addition to an average global score.
Time Frame
Baseline and 8 weeks
Title
Depression Anxiety Stress Scales (DASS)
Description
Change in symptoms of depression, anxiety, and stress at baseline and 8 weeks. A 42-item self-report questionnaire assessing three related negative emotional states: depression, anxiety, and stress. Items are scored on a 0-3 Likert scale with ranges within each emotional state for normal, mild, moderate, severe and extremely severe symptoms. Higher scores indicate more severe symptoms. Ranges in severity are reported as sum scores for each emotion state. Depression includes normal (0-9), mild (10-13), moderate (14-20), severe (21-27), extremely severe (28+). Anxiety includes normal (0-7), mild (8-9), moderate (10-14), severe (15-19) extremely severe (20+) Stress includes normal (0-14), mild (15-18) , moderate (19-25), severe (26-33) extremely severe (34+).
Time Frame
Baseline and 8 weeks
Title
Short Form-36 Health Survey (SF-36)
Description
The SF-36 is a 10-item self-report of health-related quality of life measure that generates eight scaled scored. Individual items are scored 0-100 with higher scores indicating a more favorable health state. The eight subscales, reported as weighted means as (0-100) for each scale, include physical functioning, bodily pain, role limitations due to physical health, role limitations due to personal and emotional problems, emotional well being, social functioning, energy/fatigue, general health perceptions.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
Between the ages of 18 and 60 at entry to the study.
Speak English.
Exclusion Criteria:
Clinically significant cognitive limitations or history of developmental disability.
History of neurological disorder or injury.
Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
Acute suicide risk.
Current DSM-5 alcohol or substance use disorder.
Pregnancy.
Facility Information:
Facility Name
Noom, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10001-5915
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Noom Coach for Bariatric Surgery
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