Impact of an Oral Health Intervention

NCT03921632 | Completed

• 1 other identifier: 15-3295
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder

Keywords

Anorexia nervosa; Bulimia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 6

Study Arms (1)

Education Program Effectiveness

EXPERIMENTAL

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

Behavioral: Smiles Matter Oral Health Education Series

Interventions

Smiles Matter Oral Health Education Series BEHAVIORAL

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

Education Program Effectiveness

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Center of Excellence for Eating Disorders Clinic

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 31508232 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Study Officials

• Michael Roberts, DDS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: January 1, 2016
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)