Noom Coach for Bariatric Health
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Intervention name(s): Noom Coach for Bariatric Health
Intervention type(s): Behavioral
Intervention description(s): 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 pre and or post-surgery.
Allocation: Randomized
Intervention model: Sequential Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Bariatric Surgery; mHealth