Binge Eating DisorderA-3650-0001NCT07715812
E-diary vs Paper Diary in Binge Eating Disorder
A study testing The subject will complete e-diary for 2 weeks and complete paper diary for 2 weeks in people with Binge Eating Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- The subject will complete e-diary for 2 weeks and complete paper diary for 2 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lindner Center of HOPE
Mason, Ohio, 45040
Aspen Madrid, MS, 5135360714, aspen.madrid@lindnercenter.org
About this study
Official title: 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
Read the 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
- 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?
- Conditions
- Binge Eating Disorder
- Being tested
- The subject will complete e-diary for 2 weeks, complete paper diary for 2 weeks
- Keywords
- binge eating, diary
- Medical subject headings
- Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The subject will complete e-diary for 2 weeksOther
The subject will complete one diary format and switch to the other after 2 weeks
complete paper diary for 2 weeksOther
complete paper diary for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| paper diary arm | Other | subjects will complete paper diary for 2 weeks Receives: Other: complete paper diary for 2 weeks |
| e-diary arm | Other | subjects will complete e-diary for 2 weeks Receives: Other: The subject will complete e-diary for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment v1,day 0 to v3,day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- SignanthHealth, The Lindner Center of HOPE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715812
- Sponsor's protocol ID
- A-3650-0001
- Acronym
- A-3650-0001
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary
- ClinicalTrials.gov ID
- NCT07715812
- Acronym / sponsor ID
- A-3650-0001 / A-3650-0001
- Conditions
- Binge Eating Disorder
- Keywords
- binge eating, diary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- SignanthHealth, The Lindner Center of HOPE
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paper diary arm | Other | Other: complete paper diary for 2 weekssubjects will complete paper diary for 2 weeks |
| e-diary arm | Other | Other: The subject will complete e-diary for 2 weekssubjects will complete e-diary for 2 weeks |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The subject will complete e-diary for 2 weeksThe subject will complete one diary format and switch to the other after 2 weeks | Other | e-diary arm |
| complete paper diary for 2 weekscomplete paper diary for 2 weeks | Other | paper diary arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The subject will complete e-diary for 2 weeks and complete paper diary for 2 weeks in people with Binge Eating Disorder, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna I Guerdjikova, PhD,LISW, PhD,LISW (5135360700, anna.guerdjikova@lindnercenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.