Noom Monitor for Binge Eating
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

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.
    

Intervention name(s): CBT-GSH with Noom Monitor
Intervention type(s): Behavioral
Intervention description(s): This intervention is cognitive behavioral treatment with a smartphone application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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