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

NCT04126694 | Completed

• 1 other identifier: 1907007293
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Eating Disorder Examination Questionnaire (EDE-Q)

  Assessed before each weekly treatment session throughout treatment duration (12 weeks)

• Feedback Questionnaire (FQ)

  Assessed at weekly treatment sessions throughout treatment duration (12 weeks)

• Technology Acceptance Model Scale (TAMS)

  Assessed at weekly treatment sessions throughout treatment duration (12 weeks)

Study Arms (1)

CBT with smartphone application

EXPERIMENTAL

12 weeks of CBT with SenseSupport smartphone application

Behavioral: CBT with smartphone application SenseSupport

Interventions

CBT with smartphone application SenseSupport BEHAVIORAL

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

CBT with smartphone application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 36515992 DERIVED

MeSH Terms

Conditions

Bulimia Nervosa; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: July 6, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

US (1)