Clinical trial NCT03386006: Noom Coach for Bariatric Surgery
Official title: Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
mobile health (mHealth)
psychosocial functioning
obesity
weight loss
behavioral activation
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2017-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in adherence to dietary recommendations
timeFrame: Baseline and 8 weeks
measure: Change in adherence to physical activity recommendations (Activity Tracker)
timeFrame: Ongoing
measure: Change in adherence to physical activity recommendations (IPAQ)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline and 8 weeks
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: Baseline and 8 weeks
measure: Short Form-36 Health Survey (SF-36)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Noom, Inc.
state: New York
Study officials:
References: