| CTRI Number |
CTRI/2024/05/066771 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of the impact of an Eating Disorder Intervention on dentists |
|
Scientific Title of Study
|
Impact of an eating disorder intervention utilizing the health belief model on implementation of secondary prevention measures among dentists. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Inamdar Isha Abhay |
| Designation |
Postgraduate student |
| Affiliation |
Dr. DY Patil Dental College and Hospital, Pimpri |
| Address |
Department Number 5, Public Health Dentistry Dr DY Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7588331185 |
| Fax |
|
| Email |
ishaainamdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anmol Mathur |
| Designation |
Professor Head of the Department |
| Affiliation |
Dr. D.Y. Patil Dental College & Hospital |
| Address |
Department number 5, Department of Public Health Dentistry Dr. D.Y. Patil Dental College & Hospital, Sant Tukaramnagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09899963523 |
| Fax |
|
| Email |
dranmolmathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anmol Mathur |
| Designation |
Professor Head of the Department |
| Affiliation |
Dr. D.Y. Patil Dental College & Hospital |
| Address |
Department number 5, Department of Public Health Dentistry Dr. D.Y. Patil Dental College & Hospital, Sant Tukaramnagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09899963523 |
| Fax |
|
| Email |
dranmolmathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Dr DY Patil Dental College & Hospital, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Dental College and Hospital Pimpri Pune |
| Address |
Department number 5, Department of Public Health Dentistry Dr DY Patil Dental College and HospitalSant Tukaramnagar, Pimpri, Pune 411018 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Isha Inamdar |
Dr D.Y. Patil Dental College & Hospital |
Department number 5, Department of Public Health Dentistry Dr DY Patil Dental College and HospitalSant Tukaramnagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
7588331185
ishaainamdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee. Dr. D.Y. Patil Vidyapeeth, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergraduate and practicing dentists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
knowledge based intervention |
once in 1 week power point presentation based on DSM V |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
IDA Pune registered dentists willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
IDA Pune registered dentists not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self-rated general knowledge about eating disorders and dentists’ current levels of implementation of secondary prevention measures for eating disorders based on Health Belief Model.
|
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dentists’ levels of implementation of secondary prevention measures for eating disorders after the intervention based on Health Belief Model. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
NEED FOR THE STUDY: Eating disorders are
actually serious and often fatal illnesses that are associated with severe
disturbances in people’s eating behaviors and related thoughts and emotions.
Types of
eating disorders
The most
common eating disorders are:
•
Anorexia nervosa – trying to
control your weight by not eating enough food, exercising too much, or doing
both
•
Bulimia nervosa – losing
control over how much you eat and then taking drastic action to not put on
weight
•
Binge Eating Disorder
(BED) – eating large portions of food until you feel uncomfortably full
Other
specified feeding or eating disorder (OSFED)
A person may
have an OSFED if their symptoms do not exactly fit the expected symptoms for
any specific eating disorders.
OSFED is the
most common eating disorder [7]
A central role for the dentist is
screening and early diagnosis or oral manifestations that may be linked to
various behavioral & medical disorders.
The literature contains little
information about the role of dentists in the secondary prevention of eating
disorders. These secondary prevention practices help reduce the likelihood of
the development of a full-blown eating disorder via early intervention. [1]
Along with early identification, referral by the dentists to other specialist
such as psychologists and medical professionals is also necessary. [2]
Failure
by the den tists to identify these oral manifestations may lead to more
serious systemic problems & irreversible damage to the body. [3] Early
detection & prompt treatment is crucial in cases of disordered eating as
mortality is a possible outcome if the patient is left untreated. A study,
conducted in Italy in 2022, utilizing data from 1994-2018, reported 1.72%
mortality rate over a 7.4 years of follow up. [6]
Therefore,
institutions must include efforts geared toward education of dental
practitioners regarding eating disorders. Dentists must also be assessed for
their current educational status regarding eating disorders and programmes
must be included in their curricula for the improvement of their knowledge.
[2]
The health belief model (Rosenstock
et al., 1988) is very useful in assessing a person’s inaction or
noncompliance to a certain behavior. The significance of this theory is that
it explains health behaviors and identifies leverage points for change. [2]
|
This study is
conducted to assess the dentists’ baseline levels of implementation
of secondary prevention measures for eating disorders based on Health Belief
Model and check the improvement post intervention, which is based on Diagnostic and Statistical
Manual of Mental Disorders DSM V
This study is
conducted to assess the dentists’ baseline levels of implementation
of secondary prevention measures for eating disorders based on Health Belief
Model and check the improvement post intervention, which is based on Diagnostic and Statistical
Manual of Mental Disorders DSM V.
AIM:
To assess the impact of an eating disorder
intervention on the implementation of secondary prevention measures.
OBJECTIVES:
1.
To
assess the self-rated general knowledge about eating disorders
2.
To
assess the dentists’ current levels of implementation of secondary prevention
measures for eating disorders based on Health Belief Model.
3.
To
assess the dentists’ levels of implementation of secondary prevention measures
for eating disorders after the intervention based on Health Belief Model.
METHODOLOGY:
1.
Step
1: recruiting of the dental practitioners as per the inclusion criteria
2.
Step
2: assessment of their current levels of implementation of secondary prevention
measures for eating disorders based on Health Belief Model.
3.
Step
3: intervention based on DSM V
4.
Step
4: assessment of the dentists’ levels of implementation of secondary prevention
measures for eating disorders after the intervention based on Health Belief
Model |