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

NCT ID: NCT04126694

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2021-08-01

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.

Conditions

Bulimia Nervosa; Binge Eating

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT with smartphone application

12 weeks of CBT with SenseSupport smartphone application

Group Type: EXPERIMENTAL

CBT with smartphone application SenseSupport

Intervention Type: BEHAVIORAL

SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Juarascio AS, Srivastava P, Presseller EK, Lin M, Patarinski AGG, Manasse SM, Forman EM. Using Continuous Glucose Monitoring to Detect and Intervene on Dietary Restriction in Individuals With Binge Eating: The SenseSupport Withdrawal Design Study. JMIR Form Res. 2022 Dec 14;6(12):e38479. doi: 10.2196/38479.

Reference Type: DERIVED

PMID: 36515992 (View on PubMed)

Other Identifiers

1907007293

Identifier Type: -

Identifier Source: org_study_id