The investigation of the effects of education on social stigma, body image and body image coping strategies in diabetes patients
Design
Two arm parallel group, randomised, clinical trial design of 102 patients with blindness for the statistician. By random allocation software the random blocked of 2 are made.
Settings and conduct
All patients presented to diabetes care delivery centers of Kerman university of medical sciences.
Participants/Inclusion and exclusion criteria
All diabetic patients referred to medical centers of Kerman university of medical sciences with diagnosis of diabetes and having a medical record in these centers; suffering from diabetes for at least three months; lack of self-reported mental illnesses; Age 18-40 years.
Intervention groups
In this study, education is provided to the intervention group by the researcher in four 90-minute sessions during four weeks with the number of 5-15 people. And the researcher follows up people through the available social media.
The control group received only the usual care provided by their physician.
Main outcome variables
social stigma, body omage, Body image coping strategies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047161N2
Registration date:2023-01-20, 1401/10/30
Registration timing:registered_while_recruiting
Last update:2023-01-20, 1401/10/30
Update count:0
Registration date
2023-01-20, 1401/10/30
Registrant information
Name
Omsalimeh Roudi Rashtabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
fatroody@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education on social stigma, body image and body image coping strategies of diabetic patients
Public title
The effectiveness of education on social stigma, body image and coping strategies of diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetes by a specialist doctor
Having diabetes for at least three months
Age between 18-40 years
Exclusion criteria:
Mental illness and depression diagnosed by a doctor
Participation in classes or educational interventions with a similar topic
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, random blocks of 2 are used to assign people to intervention and control groups. A total of 51 binary blocks will be used based on the specified arrangement obtained from the online randomization software "https://www.sealedenvelope.com/simple-randomiser/v1/lists". In each binary block, one person will be randomly assigned to the control group and one person to the intervention group( Allocation is determined by the software). In the begining, patients assigned to groups based on the allocation determined by software. Each group has 51 member and in total 102 people will enter the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
No.2, Ibn Sina Street, Deputy of research and technology Bldg
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.KMU.REC.1401.361
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E08.0
ICD-10 code description
Diabetes mellitus due to underlying condition with hyperosmolarity
Primary outcomes
1
Description
social stigma
Timepoint
Before entering the study, immediately and one month after the intervention
Method of measurement
diabetes stigma assessment scale
2
Description
body image
Timepoint
Before entering the study, immediately and one month after the intervention
Method of measurement
body image scale
3
Description
Body image coping strategies inventory
Timepoint
Before entering the study, immediately and one month after the intervention
Method of measurement
body image coping strategies inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention protocol is a course that includes four 90-minute weekly training sessions, in which: the prevalence of diabetes, its types, causative factors, pharmacological and non-pharmacological control methods, lifestyle changes that must be made by the individual for better control of the disease, practical training on how to inject insulin to reduce the development of lipodystrophy and atrophy, familiarization with the concept of stigma and its manifestations, identifying the presence of stigma and its effect on body image, talking about the fears and concerns of patients, familiarizing participants with the concept of body image, Familiarity with adaptive mechanisms in dealing with stress is to identify effective and ineffective adaptive mechanisms in diabetes.
Category
N/A
2
Description
Control group: In this study, the control group receives only the routine care provided to diabetic patients by their physician.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Centers affiliated to Kerman University of Medical Sciences
Full name of responsible person
Negin Jamshidi
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 397 6216
Email
fatroody@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
No. 2, Ibn Sina Street, Deputy of research and technology Bldg.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 397 6216
Email
fatroody@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi rashtabadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5201
Email
fatroody@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi rashtabadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5201
Email
fatroody@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi rashtabadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5201
Email
fatroody@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available