E-diary vs Paper Diary in Binge Eating Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The subject will complete e-diary for 2 weeks, complete paper diary for 2 weeks.
- Who it may be relevant to
- Registry conditions: Binge Eating Disorder. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary
Overview
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
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?
Interventions
- 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 - Other complete paper diary for 2 weeks
complete paper diary for 2 weeks
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Lindner Center of HOPE — Mason
Identifiers
NCT: NCT07715812 · A-3650-0001