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

Not Applicable

Completed

• Conditions: Binge Eating; Bulimia Nervosa
• Interventions: Behavioral: CBT with smartphone application SenseSupport

• Registration Number: NCT04126694
• Lead Sponsor: Drexel University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Study Start: 2020-07-06
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT with smartphone application	CBT with smartphone application SenseSupport	12 weeks of CBT with SenseSupport smartphone application

Primary Outcome Measures

Name	Time	Method
Number of weekly episodes of going ≥ 4 waking hours without eating	12 weeks	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

Name	Time	Method
Technology Acceptance Model Scale (TAMS)	Assessed at weekly treatment sessions throughout treatment duration (12 weeks)	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.
Feedback Questionnaire (FQ)	Assessed at weekly treatment sessions throughout treatment duration (12 weeks)	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.
Eating Disorder Examination Questionnaire (EDE-Q)	Assessed before each weekly treatment session throughout treatment duration (12 weeks)	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.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States