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Completed

NCT Number: NCT02555553

Noom Monitor for Binge Eating

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.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227-1098, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-GSH with Noom Monitor

Behavioral

This intervention is cognitive behavioral treatment with a smartphone application

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Kaiser Permanente
  • Noom Inc.

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2015
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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