Clinical trial NCT03887078: Noom Coach for Bariatric Health
Official title: Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric Surgery
mHealth
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2019-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two successive randomizations based on patterned response to primary intervention. Pre-surgical participants (n=200) will be randomized to groups in Noom Coach for Bariatric Health or standard care pre-surgery. Post-surgery, optimal and suboptimal responders will be randomized to Noom Bariatric or standard care. This design allows for comparisons between all 8 conditions. Contrasts allow us to answer the critical question about main effects of Noom Pre-surgery and Noom augmentation and whether this augmentation effect differs based on empirically derived classification of early response.
Primary purpose: TREATMENT

Brief summary: Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. As more Americans consider bariatric surgery for the treatment of severe obesity, it is imperative to improve factors influencing suboptimal surgical outcomes (e.g., failure to adhere to diet and exercise recommendations and psychosocial impairment). This study will evaluate the effect of the Noom Coach for Bariatric Health platform in improving standard interventions utilized in bariatric surgery programs.

Detailed description: Overweight and obesity have reached epidemic proportions in the United States. As few behavioral treatments are effective for weight loss, bariatric surgery is an increasingly important option. Although these procedures are more helpful than psychosocial treatments, post-operative weight losses vary widely, and a notable subset of patients demonstrate suboptimal weight loss or substantial weight regain. Adherence to treatment recommendations is a likely contributor to these variable outcomes. Smartphone applications (apps) designed to augment behavior change or enhance adherence, have expanded exponentially in recent years, and are a potentially useful option to improve outcomes, but rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. This study will test a combined smartphone app and health coaching system to improve adherence and behavioral/psychosocial outcomes for patients receiving bariatric surgery. The aims have not been modified since the original phase 1 and will compare usual pre-operative care and pre-surgical use of Noom Coach for Bariatric Health on post-surgery adherence and psychosocial variables in a larger test (n=200) to explore whether usage of the app is a viable predictor of subsequent post-operative weight trajectories 12 months following surgery. This study will also examine app usage as a viable predictor of subsequent post-operative weight and psychosocial trajectories in the 12 months post-surgery and establish sensitivity and specificity of early optimal response to surgical intervention using weight loss, diet and exercise adherence, and psychosocial adjustment.

Eligibility criteria: Inclusion Criteria:

* Enrolled in: (1) the Metabolic, Endocrine, and Minimally Invasive Surgery Division at Mount Sinai 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 (Wechsler Abbreviated Scale of Intelligence IQ Estimate \< 70) or history of developmental disability.
* History of neurological disorder or injury (e.g., seizure disorder or moderate or severe head injury with \>10 minutes loss of consciousness).
* Current/lifetime DSM-5 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, 8 weeks, 3 months, and 12 months
measure: Change in adherence to physical activity recommendations (Activity Tracker)
timeFrame: Baseline, 8 weeks, 3 months, and 12 months
measure: Change in adherence to physical activity recommendations (IPAQ)
timeFrame: Baseline, 8 weeks, 3, 6, 9, and 12 months
measure: Anthropometric changes (weight)
timeFrame: Baseline, 8 weeks, 3, 6, and 12 months
measure: Anthropometric changes (height)
timeFrame: Baseline, 8 weeks, 3, 6, and 12 months
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline, 8 weeks, 3, 6, 9, and 12 months
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: Baseline, 8 weeks, 3, 6, 9, and 12 months
measure: Short Form-36 Health Survey (SF-36)
timeFrame: Baseline, 8 weeks, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tom Hildebrandt, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Noom Inc.
name: Andreas Michaelides, PhD
role: PRINCIPAL_INVESTIGATOR
References: