Noom Monitor for Binge Eating

NCT ID: NCT02555553

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-05-01

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.

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.

Conditions

Binge Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

CBT-GSH with Noom Monitor

Intervention Type: BEHAVIORAL

This intervention is cognitive behavioral treatment with a smartphone application

Interventions

CBT-GSH with Noom Monitor

This intervention is cognitive behavioral treatment with a smartphone application

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noom Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Hildebrandt, PsyD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Lynn DeBar, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32008396 (View on PubMed)

Other Identifiers

GCO 14-1335

Identifier Type: -

Identifier Source: org_study_id