Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-24 @ 4:01 PM
Study NCT ID:
NCT03921632
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2019-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Oral Health Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D002032', 'term': 'Bulimia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders', 'timeFrame': 'Baseline, Week 6', 'description': 'A multiple choice survey inquiring about potential effects of eating disorders (e.g., Tooth erosion, Probable erosion sites, Tooth sensitivity, Dry mouth, Enlarged saliva glands, Oral cancer, or No pain) and Positive Self-Perception (e.g., Confidence, Appearance, Kissing, General Health Attendance) posed as Yes/No response.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anorexia nervosa', 'Bulimia'], 'conditions': ['Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '31508232', 'type': 'DERIVED', 'citation': 'Silverstein LS, Haggerty C, Sams L, Phillips C, Roberts MW. Impact of an oral health education intervention among a group of patients with eating disorders (anorexia nervosa and bulimia nervosa). J Eat Disord. 2019 Sep 5;7:29. doi: 10.1186/s40337-019-0259-x. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic.\n* Diagnosis of anorexia nervosa or bulimia nervosa\n* Aged 13-50 years\n* English-speaking\n\nExclusion Criteria:\n\n* Decisionally impaired (i.e., Incapable of providing informed consent in the opinion of the primary care provider in UNC Center for Excellence for Eating Disorders)\n* Involuntarily committed to the inpatient service of the UNC Department of Psychiatry'}, 'identificationModule': {'nctId': 'NCT03921632', 'briefTitle': 'Impact of an Oral Health Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)', 'orgStudyIdInfo': {'id': '15-3295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education Program Effectiveness', 'description': 'Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic', 'interventionNames': ['Behavioral: Smiles Matter Oral Health Education Series']}], 'interventions': [{'name': 'Smiles Matter Oral Health Education Series', 'type': 'BEHAVIORAL', 'description': 'Three sessions scheduled 2 weeks apart consisting of 15-20 minutes of didactic learning, 10 minutes of a group/personal exercise, and 10 minutes of questions that the patients have on the topic discussed that day', 'armGroupLabels': ['Education Program Effectiveness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Center of Excellence for Eating Disorders Clinic', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Michael Roberts, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 9 to 36 months following publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared.', 'accessCriteria': 'The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}