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CompletedNCT02555553Updated Sep 27, 2019

Noom Monitor for Binge Eating

An interventional study of CBT-GSH with Noom Monitor in Binge Eating Disorder, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Binge-Eating Disorder

259 studies on the registry are indexed under Binge-Eating Disorder; 54 are open to participants now.

This study's enrollment of 225 is above the median of 75 across 217 interventional studies indexed under Binge-Eating Disorder.

Browse Binge-Eating Disorder studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 772 studies on the registry; 175 are open to participants now.

Of its 124 completed or terminated interventional studies of FDA-regulated products, 83 (67%) have results posted.

Browse Icahn School of Medicine at Mount Sinai studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralCBT-GSH with Noom Monitor

    This intervention is cognitive behavioral treatment with a smartphone application

06

What researchers measure

Primary outcomes

  1. Objective Binge Days

    Objective Binge Days - Objective binge days item of Eating Disorder Examination Scale version 16 (EDE-Q V6) - Frequency of days with objective binge episodes

    Time frame: At 0 week

  2. Objective Binge Days

    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

    Time frame: At 4 weeks

  3. Objective Binge Days

    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

    Time frame: At 8 weeks

  4. Objective Binge Days

    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

    Time frame: At 12 weeks

  5. Objective Binge Days

    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

    Time frame: At 26 weeks

  6. Objective Binge Days

    Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes

    Time frame: At 52 weeks

  7. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

    Time frame: At 0 week

  8. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

    Time frame: At 4 weeks

  9. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

    Time frame: At 8 weeks

  10. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

    Time frame: At 12 weeks

  11. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6

    Time frame: At 26 weeks

  12. Sum of Compensatory Episodes

    Sum of days where vomiting, laxative, or compulsive exercise occurs -sum of 3 items on EDE-Q v6

    Time frame: At 52 weeks

Secondary outcomes

  1. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 0 week

  2. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 4 weeks

  3. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 8 weeks

  4. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 12 weeks

  5. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 26 weeks

  6. Clinical Impairment Assessment

    Full scale from 0-48, with higher score indicating more impairment

    Time frame: At 52 weeks

  7. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 0 weeks

  8. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 4 weeks

  9. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 8 weeks

  10. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 12 weeks

  11. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 26 weeks

  12. Personal Health Questionnaire

    Full scale from 0-24, with higher score indicating more depression

    Time frame: At 52 weeks

  13. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 0 week

  14. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 4 weeks

  15. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 8 weeks

  16. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 12 weeks

  17. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 26 weeks

  18. Quality of Life Scale

    Full scale from 16-112, with higher score indicating better health outcomes

    Time frame: At 52 weeks

  19. Eating Concern Subscale

    Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 0 week

  20. Eating Concern Subscale

    Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 4 weeks

  21. Eating Concern Subscale

    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 8 weeks

  22. Eating Concern Subscale

    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 12 weeks

  23. Eating Concern Subscale

    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 26 weeks

  24. Eating Concern Subscale

    Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes

    Time frame: At 52 weeks

  25. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 0 week

  26. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 4 weeks

  27. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 8 weeks

  28. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 12 weeks

  29. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 26 weeks

  30. Dietary Restraint Subscale

    Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 52 weeks

  31. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 0 week

  32. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 4 weeks

  33. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 8 weeks

  34. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 12 weeks

  35. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 26 weeks

  36. Shape Concern Subscale

    Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 52 weeks

  37. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 0 Week

  38. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 4 Weeks

  39. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 8 Weeks

  40. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 12 Weeks

  41. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 26 Weeks

  42. Weight Concern Subscale

    Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 52 Weeks

  43. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 0 week

  44. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 4 weeks

  45. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 8 weeks

  46. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 12 weeks

  47. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 26 weeks

  48. Global Eating Disorder Subscale

    Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes

    Time frame: At 52 weeks

07

Study locations

1 site
  • Kaiser Permanente Center for Health Research
    Portland, Oregon 97227-1098, United States
08

References and documents

Publications

  • 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. PubMed 32008396 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in May 2018, 25 months.

Of 99 non-industry interventional studies with no phase under Binge-Eating Disorder, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's 25 months is close to that.

Counting every sponsor, half of 104 studies reached it within 22 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2015
First posted
Sep 21, 2015
StartActual
Apr 2016
Primary completionActual
May 1, 2018
CompletionActual
May 1, 2018
Last update
Sep 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02555553
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Noom Inc., Kaiser Permanente
Responsible party
Sponsor
First posted
Sep 21, 2015
Start date
Apr 2016
Primary completion
May 1, 2018
Completion
May 1, 2018
Last update
Sep 27, 2019

Study contacts

Tom Hildebrandt, PsyD
principal investigator · Icahn School of Medicine at Mount Sinai
Lynn DeBar, PhD
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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