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Noom Monitor for Binge Eating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02555553
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Noom Inc.
Kaiser Permanente
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Behavioral: CBT-GSH with Noom Monitor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Noom Monitor for Binge Eating
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Arm Intervention/treatment
No Intervention: Treatment as Usual
The control group for the RCT will be a "usual care" condition in which participants are free to seek any assistance for their ED during the study period.
Experimental: CBT-GSH with Noom Monitor
Participation will include 12 weeks of guided cognitive-behavioral therapy- guided self help (CBT-GSH) with an MA-level health coach or nutritionist from the KPNW health plan. Patients will use a self-help book, Overcoming Binge Eating (2013) by Christopher Fairburn. The first session will last 60 minutes, and each subsequent session lasts 20-25 minutes. The first four sessions are weekly, with the subsequent four twice monthly. Self-monitoring will be conducted through Noom Monitor and individuals will receive a specialized set of instructions on how to use the monitor. Therapists will also be asked to check feedback report on clients before each session.
Behavioral: CBT-GSH with Noom Monitor
This intervention is cognitive behavioral treatment with a smartphone application




Primary Outcome Measures :
  1. Objective Binge Days [ Time Frame: At 0 week ]
    Objective Binge Days - Objective binge days item of Eating Disorder Examination Scale version 16 (EDE-Q V6) - Frequency of days with objective binge episodes

  2. Objective Binge Days [ Time Frame: At 4 weeks ]
    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

  3. Objective Binge Days [ Time Frame: At 8 weeks ]
    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

  4. Objective Binge Days [ Time Frame: At 12 weeks ]
    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

  5. Objective Binge Days [ Time Frame: At 26 weeks ]
    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

  6. Objective Binge Days [ Time Frame: At 52 weeks ]
    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

  7. Sum of Compensatory Episodes [ Time Frame: At 0 week ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

  8. Sum of Compensatory Episodes [ Time Frame: At 4 weeks ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

  9. Sum of Compensatory Episodes [ Time Frame: At 8 weeks ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

  10. Sum of Compensatory Episodes [ Time Frame: At 12 weeks ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

  11. Sum of Compensatory Episodes [ Time Frame: At 26 weeks ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

  12. Sum of Compensatory Episodes [ Time Frame: At 52 weeks ]
    Sum of days where vomiting, laxative, or compulsive exercise occurs -sum of 3 items on EDE-Q v6


Secondary Outcome Measures :
  1. Clinical Impairment Assessment [ Time Frame: At 0 week ]
    Full scale from 0-48, with higher score indicating more impairment

  2. Clinical Impairment Assessment [ Time Frame: At 4 weeks ]
    Full scale from 0-48, with higher score indicating more impairment

  3. Clinical Impairment Assessment [ Time Frame: At 8 weeks ]
    Full scale from 0-48, with higher score indicating more impairment

  4. Clinical Impairment Assessment [ Time Frame: At 12 weeks ]
    Full scale from 0-48, with higher score indicating more impairment

  5. Clinical Impairment Assessment [ Time Frame: At 26 weeks ]
    Full scale from 0-48, with higher score indicating more impairment

  6. Clinical Impairment Assessment [ Time Frame: At 52 weeks ]
    Full scale from 0-48, with higher score indicating more impairment

  7. Personal Health Questionnaire [ Time Frame: At 0 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  8. Personal Health Questionnaire [ Time Frame: At 4 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  9. Personal Health Questionnaire [ Time Frame: At 8 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  10. Personal Health Questionnaire [ Time Frame: At 12 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  11. Personal Health Questionnaire [ Time Frame: At 26 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  12. Personal Health Questionnaire [ Time Frame: At 52 weeks ]
    Full scale from 0-24, with higher score indicating more depression

  13. Quality of Life Scale [ Time Frame: At 0 week ]
    Full scale from 16-112, with higher score indicating better health outcomes

  14. Quality of Life Scale [ Time Frame: At 4 weeks ]
    Full scale from 16-112, with higher score indicating better health outcomes

  15. Quality of Life Scale [ Time Frame: At 8 weeks ]
    Full scale from 16-112, with higher score indicating better health outcomes

  16. Quality of Life Scale [ Time Frame: At 12 weeks ]
    Full scale from 16-112, with higher score indicating better health outcomes

  17. Quality of Life Scale [ Time Frame: At 26 weeks ]
    Full scale from 16-112, with higher score indicating better health outcomes

  18. Quality of Life Scale [ Time Frame: At 52 weeks ]
    Full scale from 16-112, with higher score indicating better health outcomes

  19. Eating Concern Subscale [ Time Frame: At 0 week ]
    Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes

  20. Eating Concern Subscale [ Time Frame: At 4 weeks ]
    Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes

  21. Eating Concern Subscale [ Time Frame: At 8 weeks ]
    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

  22. Eating Concern Subscale [ Time Frame: At 12 weeks ]
    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

  23. Eating Concern Subscale [ Time Frame: At 26 weeks ]
    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

  24. Eating Concern Subscale [ Time Frame: At 52 weeks ]
    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

  25. Dietary Restraint Subscale [ Time Frame: At 0 week ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  26. Dietary Restraint Subscale [ Time Frame: At 4 weeks ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  27. Dietary Restraint Subscale [ Time Frame: At 8 weeks ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  28. Dietary Restraint Subscale [ Time Frame: At 12 weeks ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  29. Dietary Restraint Subscale [ Time Frame: At 26 weeks ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  30. Dietary Restraint Subscale [ Time Frame: At 52 weeks ]
    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  31. Shape Concern Subscale [ Time Frame: At 0 week ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  32. Shape Concern Subscale [ Time Frame: At 4 weeks ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  33. Shape Concern Subscale [ Time Frame: At 8 weeks ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  34. Shape Concern Subscale [ Time Frame: At 12 weeks ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  35. Shape Concern Subscale [ Time Frame: At 26 weeks ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  36. Shape Concern Subscale [ Time Frame: At 52 weeks ]
    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  37. Weight Concern Subscale [ Time Frame: At 0 Week ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  38. Weight Concern Subscale [ Time Frame: At 4 Weeks ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  39. Weight Concern Subscale [ Time Frame: At 8 Weeks ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  40. Weight Concern Subscale [ Time Frame: At 12 Weeks ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  41. Weight Concern Subscale [ Time Frame: At 26 Weeks ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  42. Weight Concern Subscale [ Time Frame: At 52 Weeks ]
    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  43. Global Eating Disorder Subscale [ Time Frame: At 0 week ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  44. Global Eating Disorder Subscale [ Time Frame: At 4 weeks ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  45. Global Eating Disorder Subscale [ Time Frame: At 8 weeks ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  46. Global Eating Disorder Subscale [ Time Frame: At 12 weeks ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  47. Global Eating Disorder Subscale [ Time Frame: At 26 weeks ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

  48. Global Eating Disorder Subscale [ Time Frame: At 52 weeks ]
    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555553


Locations
Layout table for location information
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227-1098
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Noom Inc.
Kaiser Permanente
Investigators
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Principal Investigator: Tom Hildebrandt, PsyD Icahn School of Medicine at Mount Sinai
Principal Investigator: Lynn DeBar, PhD Kaiser Permanente

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02555553     History of Changes
Other Study ID Numbers: GCO 14-1335
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Cognitive behavioral therapy guided self-help
Mobile Mental Health
Binge Eating
Cognitive Behavioral Therapy
Eating Disorder Treatment
Self-monitoring
Eating Disorders
Ecological Momentary Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms