Binge Eating DisorderNCT02555553
Noom Monitor for Binge Eating
A study testing CBT-GSH with Noom Monitor in people with Binge Eating Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- CBT-GSH with Noom Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227-1098
About this study
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.
- Conditions
- Binge Eating Disorder
- Being tested
- CBT-GSH with Noom Monitor
- 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
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-GSH with Noom MonitorBehavioural
This intervention is cognitive behavioral treatment with a smartphone application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CBT-GSH with Noom Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 0 week
Objective Binge Days
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Measured: At 4 weeks
Objective Binge Days
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Measured: At 8 weeks
Objective Binge Days
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Measured: At 12 weeks
Objective Binge Days
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Measured: At 26 weeks
Objective Binge Days
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 52 weeks
Secondary outcomes (48)
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 0 week
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 4 weeks
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 8 weeks
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 12 weeks
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 26 weeks
Clinical Impairment Assessment
Full scale from 0-48, with higher score indicating more impairment
Measured: At 52 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 0 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 4 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 8 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 12 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 26 weeks
Personal Health Questionnaire
Full scale from 0-24, with higher score indicating more depression
Measured: At 52 weeks
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 0 week
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 4 weeks
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 8 weeks
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 12 weeks
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 26 weeks
Quality of Life Scale
Full scale from 16-112, with higher score indicating better health outcomes
Measured: At 52 weeks
Eating Concern Subscale
Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes
Measured: At 0 week
Eating Concern Subscale
Eating concern subscale of the EDE-QV6 from 0-6 with higher score indicating worse health outcomes
Measured: At 4 weeks
Eating Concern Subscale
Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes
Measured: At 8 weeks
Eating Concern Subscale
Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes
Measured: At 12 weeks
Eating Concern Subscale
Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes
Measured: At 26 weeks
Eating Concern Subscale
Eating concern subscale of the EDE-Q v6 from 0-6 with higher score indicating worse health outcomes
Measured: At 52 weeks
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 0 week
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 4 weeks
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 8 weeks
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 12 weeks
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 26 weeks
Dietary Restraint Subscale
Dietary Restraint Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 52 weeks
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 0 week
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 4 weeks
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 8 weeks
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 12 weeks
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 26 weeks
Shape Concern Subscale
Shape Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 52 weeks
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 0 Week
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 4 Weeks
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 8 Weeks
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 12 Weeks
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: At 26 Weeks
Weight Concern Subscale
Weight Concern Subscale of the EDE-Q v6 from 0-6, with higher score indicating worse health outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startApr 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Noom Inc., Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Tom Hildebrandt, PsyD, Principal investigator, Icahn School of Medicine at Mount SinaiLynn DeBar, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555553
- Sponsor's protocol ID
- GCO 14-1335
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2015
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noom Monitor for Binge Eating
- ClinicalTrials.gov ID
- NCT02555553
- Acronym / sponsor ID
- GCO 14-1335
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Noom Inc., Kaiser Permanente
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: CBT-GSH with Noom MonitorParticipation 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-GSH with Noom MonitorThis intervention is cognitive behavioral treatment with a smartphone application | Behavioural | CBT-GSH with Noom Monitor |
Primary outcome
Objective Binge Days
Time frame: At 0 week
Objective Binge Days - Objective binge days item of Eating Disorder Examination Scale version 16 (EDE-Q V6) - Frequency of days with objective binge episodes
Objective Binge Days
Time frame: At 4 weeks
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Objective Binge Days
Time frame: At 8 weeks
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Objective Binge Days
Time frame: At 12 weeks
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Objective Binge Days
Time frame: At 26 weeks
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Objective Binge Days
Time frame: At 52 weeks
Objective Binge Days - Objective binge days item of EDE-Q V6 - Frequency of days with objective binge episodes
Sum of Compensatory Episodes
Time frame: At 0 week
Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6
Sum of Compensatory Episodes
Time frame: At 4 weeks
Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6
Sum of Compensatory Episodes
Time frame: At 8 weeks
Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6
Sum of Compensatory Episodes
Time frame: At 12 weeks
Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6
Sum of Compensatory Episodes
Time frame: At 26 weeks
Sum of days where vomiting, laxative, or compulsive exercise occurs - sum of 3 items on EDE-Q v6
Sum of Compensatory Episodes
Time frame: At 52 weeks
Sum of days where vomiting, laxative, or compulsive exercise occurs -sum of 3 items on EDE-Q v6
48 secondary outcomes
Clinical Impairment Assessment
Time frame: At 0 week
Clinical Impairment Assessment
Time frame: At 4 weeks
Clinical Impairment Assessment
Time frame: At 8 weeks
Clinical Impairment Assessment
Time frame: At 12 weeks
Clinical Impairment Assessment
Time frame: At 26 weeks
Clinical Impairment Assessment
Time frame: At 52 weeks
Personal Health Questionnaire
Time frame: At 0 weeks
Personal Health Questionnaire
Time frame: At 4 weeks
Personal Health Questionnaire
Time frame: At 8 weeks
Personal Health Questionnaire
Time frame: At 12 weeks
Personal Health Questionnaire
Time frame: At 26 weeks
Personal Health Questionnaire
Time frame: At 52 weeks
Quality of Life Scale
Time frame: At 0 week
Quality of Life Scale
Time frame: At 4 weeks
Quality of Life Scale
Time frame: At 8 weeks
Quality of Life Scale
Time frame: At 12 weeks
Quality of Life Scale
Time frame: At 26 weeks
Quality of Life Scale
Time frame: At 52 weeks
Eating Concern Subscale
Time frame: At 0 week
Eating Concern Subscale
Time frame: At 4 weeks
Eating Concern Subscale
Time frame: At 8 weeks
Eating Concern Subscale
Time frame: At 12 weeks
Eating Concern Subscale
Time frame: At 26 weeks
Eating Concern Subscale
Time frame: At 52 weeks
Dietary Restraint Subscale
Time frame: At 0 week
Dietary Restraint Subscale
Time frame: At 4 weeks
Dietary Restraint Subscale
Time frame: At 8 weeks
Dietary Restraint Subscale
Time frame: At 12 weeks
Dietary Restraint Subscale
Time frame: At 26 weeks
Dietary Restraint Subscale
Time frame: At 52 weeks
Shape Concern Subscale
Time frame: At 0 week
Shape Concern Subscale
Time frame: At 4 weeks
Shape Concern Subscale
Time frame: At 8 weeks
Shape Concern Subscale
Time frame: At 12 weeks
Shape Concern Subscale
Time frame: At 26 weeks
Shape Concern Subscale
Time frame: At 52 weeks
Weight Concern Subscale
Time frame: At 0 Week
Weight Concern Subscale
Time frame: At 4 Weeks
Weight Concern Subscale
Time frame: At 8 Weeks
Weight Concern Subscale
Time frame: At 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 32008396Hildebrandt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Hildebrandt, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
Lynn DeBar, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-GSH with Noom Monitor in people with Binge Eating Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Binge Days (time frame: At 0 week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.