E-diary vs Paper Diary in Binge Eating Disorder (A-3650-0001)

July 16, 2026 updated by: Lindner Center of HOPE

A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary

The purpose of this study is to examine how binge eating episodes are recorded using two different diary formats: a paper diary and an electronic diary and to see whether both formats collect information in the same way and to understand which of the two formats is easier to use

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Binge eating (BE) diary has already been successfully employed to measure binge eating behavior in clinical trials. This has been implemented using a paper diary (p-diary) completed daily in the evening. From the diary records, binge eating episodes are confirmed by a healthcare professional. Despite the advantages of electronic implementation and the clinical and research need for such a tool, no electronic diary (e-diary) has been systematically tested in comparison to paper diary through an empirical study.

The following scientific questions are to be answered with this project

  1. Are the paper and electronic diary formats considered measurement comparable, such that data collected using the different formats across different studies or programs could be directly comparable?
  2. Are there differences in usability that might limit completion rates or lead to under reporting using one or the other mode of data collection?

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of Binge Eating Disorder based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (5) criteria (as assessed with BED module of the structural clinical interview [SCID] (6) for DSM-5)
  2. Reported frequency of minimum of 2 binge episodes/week
  3. Age: over 18 years of age
  4. Ability to understand and complete self-reporting measures 5 . The subject owns a smartphone compatible with Google Play or Apple App Store and is able to download and use apps appropriately.

Exclusion Criteria:

  1. Comorbid psychiatric conditions requiring immediate hospitalization (as assessed with MSE)
  2. IInability to use smartphone or paper diary due to physical limitations or technical barriers (e.g., severe visual impairment)
  3. Inability to read/write in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: paper diary arm
subjects will complete paper diary for 2 weeks
Other: complete paper diary for 2 weeks
complete paper diary for 2 weeks
Other: e-diary arm
subjects will complete e-diary for 2 weeks
Other: The subject will complete e-diary for 2 weeks
The subject will complete one diary format and switch to the other after 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats
Time Frame: from enrollment v1,day 0 to v3,day 30
The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats
from enrollment v1,day 0 to v3,day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lindner Center of HOPE

Collaborators

SignanthHealth
The Lindner Center of HOPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-3650-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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