Eating DisorderNCT03921632
Impact of an Oral Health Intervention
A study testing Smiles Matter Oral Health Education Series in people with Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Smiles Matter Oral Health Education Series
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center of Excellence for Eating Disorders Clinic
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Eating Disorder
- Being tested
- Smiles Matter Oral Health Education Series
- Keywords
- Anorexia nervosa, Bulimia
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smiles Matter Oral Health Education SeriesBehavioural
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 group | Role | What they receive |
|---|---|---|
| Education Program Effectiveness | Experimental | Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic Receives: Behavioral: Smiles Matter Oral Health Education Series |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Jan 2016
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roberts, DDS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921632
- Sponsor's protocol ID
- 15-3295
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared.
Publications
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.
PubMed 31508232
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)
- ClinicalTrials.gov ID
- NCT03921632
- Acronym / sponsor ID
- 15-3295
- Conditions
- Eating Disorder
- Keywords
- Anorexia nervosa, Bulimia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education Program Effectiveness | Experimental | Behavioral: Smiles Matter Oral Health Education SeriesOutpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smiles Matter Oral Health Education SeriesThree 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 | Behavioural | Education Program Effectiveness |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 31508232Silverstein 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Roberts, DDS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smiles Matter Oral Health Education Series in people with Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.