This interventional study was conducted on 170 patients with type II diabetes divided into control and intervention groups via block randomization. The educational intervention was performed for the intervention group through four 55-60-minute educational sessions. The intervention in this study was carried out through an educational program focusing on health literacy. The data were collected using health literacy level assessment questionnaire, health-improving lifestyle questionnaire, and self-efficacy assessment questionnaire. Inclusion criteria of the study were confirmation of type II diabetes by a specialist (two instances of fasting blood sugar scoring above 126 mg/deciliter), having the ability to read and write, aging between 25-55 years, signing a written informed consent for participating in the study, and absence of advanced diabetes symptoms, such as diabetic foot and joint disease. On the other hand, the exclusion criteria were lack of proper physical conditions to respond to the questions, catching chronic diseases (other than diabetes) including cancer and asthma, absence from training for more than one session, and not taking the tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507226261N12
Registration date:2015-10-13, 1394/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-13, 1394/07/21
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-01-15, 1392/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of theory-based health literacy educational program on lifestyle of diabetics
Public title
of the effect of theory-based health literacy educational program on lifestyle of diabetics
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria of the study were confirmation of type II diabetes by a specialist (two instances of fasting blood sugar scoring above 126 mg/deciliter); having the ability to read and write; aging between 25-55 years; signing a written informed consent for participating in the study; and absence of advanced diabetes symptoms such as diabetic foot and joint disease. On the other hand; the exclusion criteria were lack of proper physical conditions to respond to the questions; catching chronic diseases (other than diabetes) including cancer and asthma; absence from training for more than one session; and not taking the tests.
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical committee of Shiraz University of Medical Sciences
Street address
Zand street, Central building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
92-6852
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.8
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications
Primary outcomes
1
Description
Health literacy
Timepoint
Before intervention, one week and two months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Lifestyle
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
2
Description
Self-efficacy
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
3
Description
nutrition
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
4
Description
exercise
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
5
Description
stress management
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
6
Description
interpersonal relations
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
7
Description
health responsibility
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
8
Description
self-actualisation
Timepoint
Before intervention, one week and two months after the intervention.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group:
1. direct education on the basis of the provided educational content, using active teaching-learning methods including lectures, question and answer, small group discussions, and exchange of ideas, and 2. indirect education via manuals, pamphlets, and CDs. The intervention was carried out through educational aids, such PowerPoint, video projection, and video clips.
Category
Other
2
Description
control group: In control group was not intervention performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nader Kazemi Medical Clinic
Full name of responsible person
Hoseini
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR Syed Basir Hashemi
Street address
Zand ave, Central Building Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Kaveh
Position
Phd in Health Education , administrator of Health Education
Other areas of specialty/work
Street address
Ruzi bul, School of Health
City
Shiraz
Postal code
Phone
+98 717251002
Fax
Email
kaveh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad hosein kaveh
Position
Phd in Health Education
Other areas of specialty/work
Street address
School of Health, Ruzi bul
City
Shiraz
Postal code
Phone
+98 717251002
Fax
Email
kaveh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadije sadat Hoseini moghadam
Position
Graduate student Health Education
Other areas of specialty/work
Street address
City
Yasuj
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)