- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03921632
Impact of an Oral Health Intervention
April 16, 2019 updated by: University of North Carolina, Chapel Hill
Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)
This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Center of Excellence for Eating Disorders Clinic
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Education Program Effectiveness
Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Roberts, DDS, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
July 3, 2017
Study Completion (ACTUAL)
July 3, 2017
Study Registration Dates
First Submitted
April 16, 2019
First Submitted That Met QC Criteria
April 16, 2019
First Posted (ACTUAL)
April 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-3295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified individual data that supports the results will be shared.
IPD Sharing Time Frame
Beginning 9 to 36 months following publication
IPD Sharing 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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