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NCT Number: NCT07715812

E-diary vs Paper Diary in Binge Eating Disorder

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

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location status: Recruiting

Location contact

Aspen Madrid, MS

CONTACT

[email protected]

5135360714

About this study

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

  • 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?
  • Are there differences in usability that might limit completion rates or lead to under reporting using one or the other mode of data collection?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)
  • Reported frequency of minimum of 2 binge episodes/week
  • Age: over 18 years of age
  • 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

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

Treatment and study plan

The subject will complete e-diary for 2 weeks

Other

The subject will complete one diary format and switch to the other after 2 weeks

complete paper diary for 2 weeks

Other

complete paper diary for 2 weeks

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna I Guerdjikova, PhD,LISW, PhD,LISW

CONTACT

[email protected]

5135360700

Sponsors and collaborators

Lead sponsor

Lindner Center of HOPE

Other

Collaborators

  • SignanthHealth
  • The Lindner Center of HOPE

Registry information

Official study title

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

Acronym: A-3650-0001

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

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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