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Behavioural Intervention

Tech-based Interventions for Binge Eating (CONQUER Trial)

N/A
Recruiting
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Awards & highlights

CONQUER Trial Summary

This trial is testing a new way of providing evidence-based treatment for binge eating without clinician support using two types of tech-based interventions and a smartphone app.

Who is the study for?
This trial is for individuals in the US with a BMI of 18.5 or higher who have had at least 12 episodes of loss of control eating in the past 3 months. They must be able to consent and participate fully, not currently receiving eating disorder treatment, and not have severe mental health issues that could interfere with participation.Check my eligibility
What is being tested?
The study tests two tech-based systems: ADDS (Advanced Digital Data Sharing) with Coaches and a JITAIs (Just-in-time adaptive interventions) system, both used alongside self-help CBT via an app to see if they help people stick to treatment better and reduce binge eating.See study design
What are the potential side effects?
Since this trial involves behavioral therapy through technology without medications, side effects are minimal but may include discomfort from confronting personal eating habits or stress from regular engagement with the intervention tools.

CONQUER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binge eating frequency
Frequency of skills utilization
Rates of self-monitoring compliance
+1 more
Secondary outcome measures
Acceptability
Acceptability and Feasibility
Compensatory behavior frequency
+1 more

CONQUER Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs)Experimental Treatment2 Interventions
When JITAIs are turned ON, the base self-help app will be used to deliver targeted, personalized and automated interventions during algorithm-identified moments when participants could benefit from receiving an intervention for improving two key areas including 1) treatment adherence, and 2) skills utilization based on responses (or lack thereof) in self-help app. When JITAIs are turned OFF, participants will not receive interventions in real-time on the base self-help app.
Group II: Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with CoachesExperimental Treatment3 Interventions
When Advanced DDS with Coaches and JITAIs are both ON, participants will receive machine learning-informed interventions. In addition, participants will also receive weekly emails from coaches to provide additional support to improve treatment adherence and skills utilization.
Group III: Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with CoachesExperimental Treatment2 Interventions
When Advanced DDS with Coaches is turned ON, coaches having a bachelor's degree in health-related fields will have access to a secure web portal called the clinical portal. The portal will also mimic four key behavior change techniques typically employed by an expert clinician including 1) gather data on target behaviors from the base self-help app (i.e., uptake of weekly module, self-monitoring compliance, and skills use), 2) synthesize participants' behavioral data on treatment targets, 3) flag data to indicate behaviors needing improvement and 4) use sophisticated algorithms to generate recommendations for intervening on identified data patterns. Using this information, the coaches will send one weekly email to facilitate improvement in treatment targets over 12 weeks. When Advanced DDS with Coaches is turned OFF, participants' will not have their data shared and will not receive emails from the coaches.
Group IV: Base self-help cognitive behavior therapy (CBT) programActive Control1 Intervention
The self-help app will deliver 12 modules that will be based on Chris Fairburn's "Overcoming Binge Eating" self-help book, the most widely used self-help resource for binge eating. Treatment modules will aim to 1) provide psychoeducation on maintenance factors for binge eating, 2) teach CBT skills designed to interrupt these maintenance factors, and 3) coach participants to set personalized goals each week. Modules will be completed in succession over the course of 12 weeks and a new module will be made open each week. At the end of each weekly module, participants will complete an end-of-the-week survey and report on the frequency of skills use in the past week. In addition, participants will track their eating and eating disorder behaviors using the self-help app.

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor
150 Previous Clinical Trials
47,625 Total Patients Enrolled
13 Trials studying Bulimia
1,138 Patients Enrolled for Bulimia

Media Library

Base self-help CBT program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05937243 — N/A
Bulimia Research Study Groups: Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches, Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs), Base self-help cognitive behavior therapy (CBT) program, Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches
Bulimia Clinical Trial 2023: Base self-help CBT program Highlights & Side Effects. Trial Name: NCT05937243 — N/A
Base self-help CBT program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937243 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this trial encompass persons of more advanced age?

"This clinical trial requires that participants are between 18 and 65 years old, with 50 trials intended for those under the age of majority and 53 dedicated to adults over 65."

Answered by AI

How many participants are being recruited into this clinical trial?

"Affirmative, the clinicaltrials.gov website verifies that this medical trial is currently seeking patients. It was posted on September 1st 2022 and last modified on July 5th 2023; 76 volunteers are wanted from a single location."

Answered by AI

Are there any open slots that participants may access for this experiment?

"According to the information presented on clinicaltrials.gov, this experiment is actively recruiting participants. It was posted for public viewing on September 1st 2022 and updated most recently in July of 2023."

Answered by AI

Is it possible for me to take part in this clinical research?

"To meet the requirements of this trial, applicants must have bulimia and fall between 18-65 years old. Approximately 76 people are needed for the study to be completed."

Answered by AI

What aim is this clinical experiment attempting to fulfill?

"The primary objective of this clinical trial, taking place over a twelve week period and followed by three months of post-treatment evaluation, is to quantify the number of treatment modules completed. Secondary aims include measuring compensatory behavior frequency through the Eating disorder Examination (EDE), gauging acceptability with Technology Acceptance Model (TAM) scales and a Feedback Questionnaire as well as assessing feasibility in terms of enrolment rate, dropout rate and study retention. Additionally, data will be gathered regarding participants' utilization of self-help technological elements such as time span or regularity."

Answered by AI

Who else is applying?

What site did they apply to?
Drexel University
What portion of applicants met pre-screening criteria?
Met criteria
~35 spots leftby Aug 2025