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.

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Behavioral: CBT-GSH with Noom Monitor

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 4 weeks
Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 8 weeks
Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 12 weeks
Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 26 weeks
Objective Binge Days	Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes	At 52 weeks
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 0 week
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 4 weeks
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 8 weeks
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 12 weeks
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 26 weeks
Clinical Impairment Assessment	Full scale from 0-48, with higher score indicating more impairment	At 52 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 0 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 4 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 8 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 12 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 26 weeks
Personal Health Questionnaire	Full scale from 0-24, with higher score indicating more depression	At 52 weeks
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 0 week
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 4 weeks
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 8 weeks
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 12 weeks
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 26 weeks
Quality of Life Scale	Full scale from 16-112, with higher score indicating better health outcomes	At 52 weeks
Eating Concern Subscale	Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes	At 0 week
Eating Concern Subscale	Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes	At 4 weeks
Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 8 weeks
Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 12 weeks
Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 26 weeks
Eating Concern Subscale	Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes	At 52 weeks
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 week
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 weeks
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 weeks
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 weeks
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 weeks
Dietary Restraint Subscale	Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 weeks
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 week
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 weeks
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 weeks
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 weeks
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 weeks
Shape Concern Subscale	Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 weeks
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 0 Week
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 4 Weeks
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 8 Weeks
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 12 Weeks
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 26 Weeks
Weight Concern Subscale	Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes	At 52 Weeks
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Kaiser Permanente; Noom Inc.
• Investigators: Principal Investigator: Lynn DeBar, PhD, Kaiser Permanente; Principal Investigator: Tom Hildebrandt, PsyD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Binge Eating; Self-monitoring; Eating Disorders; Cognitive behavioral therapy guided self-help; Mobile Mental Health; Eating Disorder Treatment; Ecological Momentary Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: GCO 14-1335

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No