NCT07715812

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 7, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

binge eating, diary

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats

    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

Study Arms (2)

paper diary arm

OTHER

subjects will complete paper diary for 2 weeks

Other: complete paper diary for 2 weeks

e-diary arm

OTHER

subjects will complete e-diary for 2 weeks

Other: The subject will complete e-diary for 2 weeks

Interventions

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

e-diary arm

complete paper diary for 2 weeks

paper diary arm

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating DisorderBulimia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna I Guerdjikova, PhD,LISW, PhD,LISW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 20, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations