Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology

Bulimia Nervosa Clinical Trial

Official title:

Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126694
• Other study ID #: 1907007293
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa

Intervention

Behavioral:
• CBT with smartphone application SenseSupport
SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	Assessed before each weekly treatment session throughout treatment duration (12 weeks)
Secondary	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.	Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Secondary	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.	Assessed at weekly treatment sessions throughout treatment duration (12 weeks)