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Impact of an Oral Health Intervention

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ClinicalTrials.gov Identifier: NCT03921632
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE January 1, 2016
Actual Primary Completion Date July 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders [ Time Frame: Baseline, Week 6 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of an Oral Health Intervention
Official Title  ICMJE Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)
Brief Summary This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Primary Purpose: Other
Condition  ICMJE Eating Disorder
Intervention  ICMJE Behavioral: Smiles Matter Oral Health Education Series
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
Study Arms  ICMJE Experimental: Education Program Effectiveness
Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic
Intervention: Behavioral: Smiles Matter Oral Health Education Series
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 3, 2017
Actual Primary Completion Date July 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic.
  • Diagnosis of anorexia nervosa or bulimia nervosa
  • Aged 13-50 years
  • English-speaking

Exclusion Criteria:

  • 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)
  • Involuntarily committed to the inpatient service of the UNC Department of Psychiatry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921632
Other Study ID Numbers  ICMJE 15-3295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared.
Time Frame: Beginning 9 to 36 months following publication
Access Criteria: 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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Roberts, DDS University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP