Clinical trial NCT04126694: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Binge Eating
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of weekly episodes of going ≥ 4 waking hours without eating
timeFrame: 12 weeks
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Assessed before each weekly treatment session throughout treatment duration (12 weeks)
measure: Feedback Questionnaire (FQ)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
measure: Technology Acceptance Model Scale (TAMS)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References: