Back to resultsUsing Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
Primary Purpose
Bulimia Nervosa, Binge Eating
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT with smartphone application SenseSupport
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa
Eligibility Criteria
Inclusion Criteria:
- Are 18 to 65 years old
- Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
- Engage in clinically significant dietary restriction (define as >1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
- Have a BMI above 18.5
- Are able to give consent
Exclusion Criteria:
- Are unable to fluently speak, write and read English
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
- Have diabetes
- Are pregnant or planning to become pregnant within the next year
Sites / Locations
- Drexel University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT with smartphone application
Arm Description
12 weeks of CBT with SenseSupport smartphone application
Outcomes
Primary Outcome Measures
Number of weekly episodes of going ≥ 4 waking hours without eating
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restriction for the participant.
Secondary Outcome Measures
Eating Disorder Examination Questionnaire (EDE-Q)
The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint.
Feedback Questionnaire (FQ)
The feedback questionnaire asks qualitative questions about the application. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings.
Technology Acceptance Model Scale (TAMS)
The Technology Acceptance Model Scale measures usefulness and ease of use of a technological product. The TAMS yields two subscale scores (usefulness and ease of use). The possible score range for each subscale is 6 to 49. Higher scores indicate greater usefulness and ease of use. The TAMS will be used to assess the perceived usefulness and perceived ease-of-use of the smartphone application to evaluate acceptability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04126694
Brief Title
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
Official Title
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge Eating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive 12 sessions of in-person CBT delivered over 12 weeks. In weeks 1-2, participants will wear the CGM devices, but will not receive JITAIs and therapists will not have access to the clinician portal. During weeks 3-4, JITAIs will be "turned on" such that patients begin to receive push notifications based on CGM data and therapists will have access to the clinician portal. The A/B periods will be repeated (weeks 5-6 and 9-10, SenseSupport Off; weeks 7-8 and 11-12 SenseSupport On) to ensure that improvements in dietary restriction are due to SenseSupport and not simply to the effect of time in treatment. Similar to the approach used in prior studies, participants will be ran in small waves (n= 3-5 per wave). During each wave, feasibility, acceptability, and target engagement will be assessed, and if acceptable milestones have not been achieved, SenseSupport will be modified before beginning the next wave.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT with smartphone application
Arm Type
Experimental
Arm Description
12 weeks of CBT with SenseSupport smartphone application
Intervention Type
Behavioral
Intervention Name(s)
CBT with smartphone application SenseSupport
Intervention Description
SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology
Primary Outcome Measure Information:
Title
Number of weekly episodes of going ≥ 4 waking hours without eating
Description
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restriction for the participant.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint.
Time Frame
Assessed before each weekly treatment session throughout treatment duration (12 weeks)
Title
Feedback Questionnaire (FQ)
Description
The feedback questionnaire asks qualitative questions about the application. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Title
Technology Acceptance Model Scale (TAMS)
Description
The Technology Acceptance Model Scale measures usefulness and ease of use of a technological product. The TAMS yields two subscale scores (usefulness and ease of use). The possible score range for each subscale is 6 to 49. Higher scores indicate greater usefulness and ease of use. The TAMS will be used to assess the perceived usefulness and perceived ease-of-use of the smartphone application to evaluate acceptability.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are 18 to 65 years old
Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
Engage in clinically significant dietary restriction (define as >1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
Have a BMI above 18.5
Are able to give consent
Exclusion Criteria:
Are unable to fluently speak, write and read English
Are receiving treatment for an eating disorder
Require immediate treatment for medical complications as a result of eating disorder symptoms
Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
Have diabetes
Are pregnant or planning to become pregnant within the next year
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
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