Noom Monitor for Binge Eating

Binge Eating Disorder Clinical Trial

Official title:

Noom Monitor for Binge Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555553
• Other study ID #: GCO 14-1335
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• CBT-GSH with Noom Monitor
This intervention is cognitive behavioral treatment with a smartphone application

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Kaiser Permanente, Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 0 week
Primary	Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 4 weeks
Primary	Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 8 weeks
Primary	Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 12 weeks
Primary	Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 26 weeks
Primary	Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 52 weeks
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6	At 0 week
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6	At 4 weeks
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6	At 8 weeks
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6	At 12 weeks
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6	At 26 weeks
Primary	Sum of Compensatory Episodes	Sum of days where vomiting, laxative, or compulsive exercise occurs -sum of 3 items on EDE-Q v6	At 52 weeks
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 0 week
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 4 weeks
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 8 weeks
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 12 weeks
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 26 weeks
Secondary	Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 52 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 0 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 4 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 8 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 12 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 26 weeks
Secondary	Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 52 weeks
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 0 week
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 4 weeks
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 8 weeks
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 12 weeks
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 26 weeks
Secondary	Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 52 weeks
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes	At 0 week
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes	At 4 weeks
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 8 weeks
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 12 weeks
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 26 weeks
Secondary	Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 52 weeks
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 week
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 weeks
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 weeks
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 weeks
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 weeks
Secondary	Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 weeks
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 week
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 weeks
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 weeks
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 weeks
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 weeks
Secondary	Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 weeks
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 Week
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 Weeks
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 Weeks
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 Weeks
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 Weeks
Secondary	Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 Weeks
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 week
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 weeks
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 weeks
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 weeks
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 weeks
Secondary	Global Eating Disorder Subscale	Global Eating Disorder Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 weeks