Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 8:48 PM
Study NCT ID:
NCT05641350
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098382', 'term': 'Emotional Eating'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emotional Eating']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern.\n\nThe design is quasi-experimental pre-post with a control group (waiting list) and evaluation of the maintenance of the response after 6 months of the end of the program.\n\nIncludes outpatients from the Eating Disorders Unit and the Psychiatry Unit of a Hospital. A sample size of 26 participants is considered in the experimental group, and another 26 more in the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients from eating behavior disorder outpatient clinics and psychiatric outpatient clinics.\n* Age between 18 and 65 years.\n* Score of more than 2.46 on the "emotional eating" subscale of the DEBQ scale\n\nExclusion Criteria:\n\n* Diagnosis of active Eating Disorder, that is, without at least 6 months of symptomatic remission or that exceed the cut-off point on the EAT-26 scale.\n* Patients with severe mental disorder with or without psychotic symptoms (schizophreniform disorders, bipolar spectrum disorders, major depression)\n* Patients with some other medical disorder that presents with impulse dysregulation, such as epilepsy, frontal-type dementia...\n* Patients with an IQ \\< 85\n* Patients who do not give consent.\n* Patients who do not understand or speak Spanish or Catalan.'}, 'identificationModule': {'nctId': 'NCT05641350', 'acronym': 'BITE', 'briefTitle': "Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design", 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': "Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design", 'orgStudyIdInfo': {'id': 'IIBSP-BIT-2022-78'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional eating intervention', 'description': 'Emotional eating intervention', 'interventionNames': ["Behavioral: Barlow's Unified Protocol"]}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list', 'description': 'Waiting list'}], 'interventions': [{'name': "Barlow's Unified Protocol", 'type': 'BEHAVIORAL', 'description': "Adaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern.", 'armGroupLabels': ['Emotional eating intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': "Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}