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Impact of an Oral Health Intervention

Primary Purpose

Eating Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Smiles Matter Oral Health Education Series

About this trial

This is an interventional other trial for Eating Disorder focused on measuring Anorexia nervosa, Bulimia

Eligibility Criteria

13 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UNC Center of Excellence for Eating Disorders Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Education Program Effectiveness

Arm Description

Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic

Outcomes

Primary Outcome Measures

Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03921632

First Posted

April 16, 2019

Last Updated

April 16, 2019

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT03921632

Brief Title

Impact of an Oral Health Intervention

Official Title

Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

July 3, 2017 (Actual)

Study Completion Date

July 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eating Disorder

Keywords

Anorexia nervosa, Bulimia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education Program Effectiveness

Arm Type

Experimental

Arm Description

Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic

Intervention Type

Behavioral

Intervention Name(s)

Smiles Matter Oral Health Education Series

Intervention 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

Primary Outcome Measure Information:

Title

Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders

Description

Time Frame

Baseline, Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Roberts, DDS

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Center of Excellence for Eating Disorders Clinic

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

31508232

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.

Results Reference

derived

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Impact of an Oral Health Intervention

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