Assessing the effect of educational intervention to improve adherence to the diet in patients with type 2 diabetes referred to health centers in south Tehran 2015 -2016 :health belief model
1) Objectives :To determine the effect of educational intervention to improve adherence to the diet in patients with type 2 diabetes referred to health centers in south Tehran 2015 -2016 :health belief model. (2) Design :Clinical trial comparing the two groups.(3) Setting and conduct :The study involved two groups compared with the population studied, patients with type 2 diabetes who were referred to health centers in south Tehran. 216 samples were randomly divided into 2 groups were compared. (4) Participants including major eligibility criteria :Terms of Inclusion: patients diagnosed with diabetes, there is a desire to participate in the study, no known mental illness, spent at least one year from the definitive diagnosis of diabetes and major condition exclusion: unwillingness to participate in the study considered was.(5) Intervention : After determining the sample questionnaire is completed by both intervention and comparison groups. Then, according to data collected for the study group during the month, 6 training sessions for 45 to 60 minutes for group training and Q & A, as well as providing training package will take place after the impact of an educational intervention questionnaire 3 and 6 months after the training is completed for both intervention and comparison groups and using spss software version 11.5 is significantly lower than the 0.05 level will be analyzed. (6) main outcome measures (variables) : to improve adherence to the diet.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080212460N7
Registration date:2015-09-09, 1394/06/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Educational and Research vice chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2015-10-05, 1394/07/13
Expected recruitment end date
2016-02-05, 1394/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of educational intervention to improve adherence to the diet in patients with type 2 diabetes referred to health centers in south Tehran 2015 -2016 :health belief model
Public title
Assessing the effect of educational intervention to improve adherence to the diet in patients with type 2 diabetes referred to health centers in south Tehran 2015 -2016 :health belief model
Purpose
Other
Inclusion/Exclusion criteria
Terms of Inclusion : patients diagnosed with diabetes؛ there is a desire to participate in the study؛ no known mental illness؛ spent at least one year from the definitive diagnosis of diabetes and major condition exclusion : unwillingness to participate in the study considered was.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
216
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
The ethics committee of Tehran University of Medical Sciences
Street address
Poursina Ave.
City
Tehran
Postal code
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
IR.TUMS.REC.1394.457
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes
2
Description of health condition studied
Adherence to the diet
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
Adherence to the diet
Timepoint
Baseline and 3 and 6 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Health Belife Model constructs
Timepoint
Baseline and 3 and 6 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention program will be conducted during one month including six educational sessions based on blended educational intervention program (Lecture, Group discussion, Question & Answer, Role playing, Educational film). The length of each session is about 45-60 minutes . The meetings will be tried on diabetes, its complications, and how to follow the diet, diabetic diet and be content to be discussed.
Category
Prevention
2
Description
In control group, education will be conducted based on routine plan of health centers.