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Completed

NCT Number: NCT04126694

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

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.

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Key information

Conditions

Bulimia Nervosa Binge Eating Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of weekly episodes of going ≥ 4 waking hours without eating

    Time frame: 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 outcomes

  1. Eating Disorder Examination Questionnaire (EDE-Q)

    Time frame: 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.

  2. Feedback Questionnaire (FQ)

    Time frame: 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.

  3. Technology Acceptance Model Scale (TAMS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2019
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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