Clinical trial NCT02555553: Noom Monitor for Binge Eating
Official title: Noom Monitor for Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: Cognitive behavioral therapy guided self-help
Mobile Mental Health
Binge Eating
Cognitive Behavioral Therapy
Eating Disorder Treatment
Self-monitoring
Eating Disorders
Ecological Momentary Intervention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Noom Inc.
name: Kaiser Permanente
First posted: 2015-09-21
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed Phase II STTR study is to test the primary efficacy of a novel mobile app, 'Noom Monitor,' in a large population of binge eaters in the Kaiser Permanente health care system relative to a well-established treatment as usual (TAU) control condition. Noom Monitor facilitates the delivery of CBT-GSH by utilizing a patient interface that increases adherence and provides between-session reminders of CBT-GSH principles. In addition, the Noom Monitor includes a therapist interface with weekly feedback to the provider about patient progress. This application has several primary objectives, including: (1) testing the real-world effectiveness of the Noom Monitor in a clinical setting, and (2) establishing a database of training materials for Noom Monitor. The knowledge gained from the current study will contribute to our understanding of the role of new emerging mobile technologies in augmenting existing treatments.

Detailed description: Binge eating is a core maladaptive behavior characteristic of several forms of eating pathology, including bulimia nervosa (BN) and binge eating disorder (BED). These chronic conditions affect approximately 5% of the population, and cause significant psychosocial and physical impairment. However, a number of barriers prevent the implementation of effective treatments, including poor treatment adherence, a paucity of specialized therapists, and high rates of drop out. The guided self-help version of cognitive-behavior therapy (CBT-GSH) is a brief 8-session highly scalable treatment to reduce binge eating. Moreover, CBT-GSH is a cost-effective empirically supported treatment that has been demonstrated to reduce total health care costs.

Although CBT-GSH for BN and BED is effective, few individuals receive these treatments and the majority of other available treatments do not meet adequate standards for care for eating disorders. There are a number of reasons for why this is the case, but an important concern about CBT-GSH is participant burden. The primary CBT-GSH intervention is self-monitoring, a uniquely effective technique for reducing binge eating episodes; however, traditional self-monitoring is time-intensive and cumbersome because of its paper-and-pencil format. In addition, other behavioral strategies utilized in CBT-GSH (e.g., the development of regular eating) require a high degree of participant engagement outside of session. Novel technologies, such as those available with smartphones, offer potentially important means for reducing participant burden in the delivery of CBT-GSH. The purpose of the proposed is to test the primary efficacy of a novel mobile app, 'Noom Monitor' in a large population of binge eaters relative to a well-established treatment as usual (TAU) control condition. The investigative team developed these products via phase I study (R41-MH096435) to facilitate delivery of a cognitive-behavior therapy version of Guided Self-Help.

The efficacy and product development aims of this proposal will be used to support the commercial launch of Noom Monitor, a smartphone platform.

Eligibility criteria: Inclusion Criteria:

* Meets for DSM-5 BN or BED criteria
* Between the ages of 18 and 55
* Males and females
* BMI greater than 18.5 and less than 40
* Medical clearance in the case of reported purging or extreme exercise
* Free of psychiatric medication for at least 2 weeks prior to study or on a stable dose of medication for 4 weeks
* 1 year continuous enrollment in Kaiser Permanente Northwest health plan

Exclusion Criteria:

* Has undergone bariatric surgery
* Demonstrates need for higher level of care (e.g., very low weight (\<18.5))
* Current comorbid substance dependence, bipolar or psychotic illness
* Current suicidal ideation
* Previously received Enhance Cognitive behavioral therapy or Cognitive behavioral therapy-guided self help
* Previously read Overcoming Binge Eating by Christopher Fairburn
* Purging and/or laxative use more than 2x a day on average over the last month.

Primary outcomes:
measure: Objective Binge Days
timeFrame: At 0 week
measure: Objective Binge Days
timeFrame: At 4 weeks
measure: Objective Binge Days
timeFrame: At 8 weeks
measure: Objective Binge Days
timeFrame: At 12 weeks
measure: Objective Binge Days
timeFrame: At 26 weeks
measure: Objective Binge Days
timeFrame: At 52 weeks
measure: Sum of Compensatory Episodes
timeFrame: At 0 week
measure: Sum of Compensatory Episodes
timeFrame: At 4 weeks
measure: Sum of Compensatory Episodes
timeFrame: At 8 weeks
measure: Sum of Compensatory Episodes
timeFrame: At 12 weeks
measure: Sum of Compensatory Episodes
timeFrame: At 26 weeks
measure: Sum of Compensatory Episodes
timeFrame: At 52 weeks
Secondary outcomes:
measure: Clinical Impairment Assessment
timeFrame: At 0 week
measure: Clinical Impairment Assessment
timeFrame: At 4 weeks
measure: Clinical Impairment Assessment
timeFrame: At 8 weeks
measure: Clinical Impairment Assessment
timeFrame: At 12 weeks
measure: Clinical Impairment Assessment
timeFrame: At 26 weeks
measure: Clinical Impairment Assessment
timeFrame: At 52 weeks
measure: Personal Health Questionnaire
timeFrame: At 0 weeks
measure: Personal Health Questionnaire
timeFrame: At 4 weeks
measure: Personal Health Questionnaire
timeFrame: At 8 weeks
measure: Personal Health Questionnaire
timeFrame: At 12 weeks
measure: Personal Health Questionnaire
timeFrame: At 26 weeks
measure: Personal Health Questionnaire
timeFrame: At 52 weeks
measure: Quality of Life Scale
timeFrame: At 0 week
measure: Quality of Life Scale
timeFrame: At 4 weeks
measure: Quality of Life Scale
timeFrame: At 8 weeks
measure: Quality of Life Scale
timeFrame: At 12 weeks
measure: Quality of Life Scale
timeFrame: At 26 weeks
measure: Quality of Life Scale
timeFrame: At 52 weeks
measure: Eating Concern Subscale
timeFrame: At 0 week
measure: Eating Concern Subscale
timeFrame: At 4 weeks
measure: Eating Concern Subscale
timeFrame: At 8 weeks
measure: Eating Concern Subscale
timeFrame: At 12 weeks
measure: Eating Concern Subscale
timeFrame: At 26 weeks
measure: Eating Concern Subscale
timeFrame: At 52 weeks
measure: Dietary Restraint Subscale
timeFrame: At 0 week
measure: Dietary Restraint Subscale
timeFrame: At 4 weeks
measure: Dietary Restraint Subscale
timeFrame: At 8 weeks
measure: Dietary Restraint Subscale
timeFrame: At 12 weeks
measure: Dietary Restraint Subscale
timeFrame: At 26 weeks
measure: Dietary Restraint Subscale
timeFrame: At 52 weeks
measure: Shape Concern Subscale
timeFrame: At 0 week
measure: Shape Concern Subscale
timeFrame: At 4 weeks
measure: Shape Concern Subscale
timeFrame: At 8 weeks
measure: Shape Concern Subscale
timeFrame: At 12 weeks
measure: Shape Concern Subscale
timeFrame: At 26 weeks
measure: Shape Concern Subscale
timeFrame: At 52 weeks
measure: Weight Concern Subscale
timeFrame: At 0 Week
measure: Weight Concern Subscale
timeFrame: At 4 Weeks
measure: Weight Concern Subscale
timeFrame: At 8 Weeks
measure: Weight Concern Subscale
timeFrame: At 12 Weeks
measure: Weight Concern Subscale
timeFrame: At 26 Weeks
measure: Weight Concern Subscale
timeFrame: At 52 Weeks
measure: Global Eating Disorder Subscale
timeFrame: At 0 week
measure: Global Eating Disorder Subscale
timeFrame: At 4 weeks
measure: Global Eating Disorder Subscale
timeFrame: At 8 weeks
measure: Global Eating Disorder Subscale
timeFrame: At 12 weeks
measure: Global Eating Disorder Subscale
timeFrame: At 26 weeks
measure: Global Eating Disorder Subscale
timeFrame: At 52 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tom Hildebrandt, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Lynn DeBar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hildebrandt T, Michaeledes A, Mayhew M, Greif R, Sysko R, Toro-Ramos T, DeBar L. Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating. Am J Psychiatry. 2020 Feb 1;177(2):134-142. doi: 10.1176/appi.ajp.2019.19020184.