NCT02555553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

September 17, 2015

Last Update Submit

September 25, 2019

Conditions

Binge Eating Disorder

Keywords

Cognitive behavioral therapy guided self-helpMobile Mental HealthBinge EatingCognitive Behavioral TherapyEating Disorder TreatmentSelf-monitoringEating DisordersEcological Momentary Intervention

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (48)

  • Clinical Impairment Assessment

    At 0 week

  • Clinical Impairment Assessment

    At 4 weeks

  • Clinical Impairment Assessment

    At 8 weeks

  • Clinical Impairment Assessment

    At 12 weeks

  • Clinical Impairment Assessment

    At 26 weeks

  • +43 more secondary outcomes

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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.

CBT-GSH with Noom Monitor

EXPERIMENTAL

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

CBT-GSH with Noom MonitorBEHAVIORAL

This intervention is cognitive behavioral treatment with a smartphone application

CBT-GSH with Noom Monitor

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • year continuous enrollment in Kaiser Permanente Northwest health plan

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227-1098, United States

Location

Related Publications (1)

  • 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.

    PMID: 32008396DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderBulimiaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tom Hildebrandt, PsyD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Lynn DeBar, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 21, 2015

Study Start

April 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

US(1)