[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715812":3,"trial-entities:NCT07715812":76,"trial-summary:NCT07715812":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":50,"locations":53,"central_contacts":68,"overall_officials":73,"references":74,"see_also_links":75},"NCT07715812","A-3650-0001","E-diary vs Paper Diary in Binge Eating Disorder","A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary","RECRUITING","2028-03-30","2026-07","2026-07-20","2026-07-30","Lindner Center of HOPE","OTHER",false,"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","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.\n\nThe following scientific questions are to be answered with this project\n\n1. 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?\n2. Are there differences in usability that might limit completion rates or lead to under reporting using one or the other mode of data collection?",[19],"Binge Eating Disorder",[21],"binge eating, diary","INTERVENTIONAL",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29,34],{"type":14,"name":30,"description":31,"armGroupLabels":32},"The subject will complete e-diary for 2 weeks","The subject will complete one diary format and switch to the other after 2 weeks",[33],"e-diary arm",{"type":14,"name":35,"description":35,"armGroupLabels":36},"complete paper diary for 2 weeks",[37],"paper diary arm",[39],{"measure":40,"description":40,"timeFrame":41},"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",[],"ALL",null,"18 Years",{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria:\n\n1. 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)\n2. Reported frequency of minimum of 2 binge episodes\u002Fweek\n3. Age: over 18 years of age\n4. 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.\n\nExclusion Criteria:\n\n1. Comorbid psychiatric conditions requiring immediate hospitalization (as assessed with MSE)\n2. IInability to use smartphone or paper diary due to physical limitations or technical barriers (e.g., severe visual impairment)\n3. Inability to read\u002Fwrite in English",[51,52],"CHILD","ADULT",[54],{"facility":13,"status":8,"city":55,"state":56,"zip":57,"country":58,"contacts":59,"geoPoint":65},"Mason","Ohio","45040","United States",[60],{"name":61,"role":62,"phone":63,"email":64},"Aspen Madrid, MS","CONTACT","5135360714","aspen.madrid@lindnercenter.org",{"lat":66,"lon":67},39.36006,-84.30994,[69],{"name":70,"role":62,"phone":71,"email":72},"Anna I Guerdjikova, PhD,LISW, PhD,LISW","5135360700","anna.guerdjikova@lindnercenter.org",[],[],[],{"nct_id":4,"conditions":77,"biomarkers":79},[78],"Binge Eating",[],{"nct_id":4,"found":81,"summary":82,"prompt_version":92},true,{"design":83,"status":84,"heading":85,"summary":86,"follow_up":87,"word_count":88,"commitments":89,"compensation":90,"drugs_mentioned":91},"This interventional study plans to enroll 40 participants. It compares two different diary formats for recording binge eating episodes.","completed","E-diary vs. Paper Diary for Binge Eating Disorder","This study is looking at how people with Binge Eating Disorder (BED) record their binge eating episodes using two different methods: an electronic diary (e-diary) and a paper diary. The goal is to see if both methods collect the same information and which one is easier to use. You could be eligible if you have a diagnosis of Binge Eating Disorder, experience at least two binge episodes per week, and are over 18 years old. The study will compare the number of binge eating episodes recorded over a 14-day period between the two diary formats. The current status of this study is unclear.","The primary endpoint measures binge eating episodes over a 14-day period, from enrollment to day 30.",103,"You will complete one diary format for two weeks, then switch to the other format for another two weeks. This will involve recording your binge eating episodes daily.","Not stated in the trial record.",[],"v2"]