Determining the effect of an educational intervention based on the Mediterranean diet on the modification of the dietary pattern of type 2 diabetic women in Ilam
Design
An experimental study with a control group and a total sample size of 124 people, randomized by multi-stage random sampling method, with a 3-month follow-up after the end of the intervention
Settings and conduct
Study location: two comprehensive urban health service centers in Ilam city, study population: middle-aged women with type 2 diabetes, blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 30-59 years, definitive diagnosis of type 2 diabetes, active care file at the comprehensive urban health service center, taking blood sugar-lowering oral medications, ability to participate in educational programs.
Exclusion criteria: insulin injection, having any physical or mental illness preventing participation in the intervention, severe kidney and eye problems, pregnancy, smoking
Intervention groups
Intervention group: receiving an educational intervention based on the Mediterranean diet; Control group: receiving routine health care and not receiving the intervention
Main outcome variables
Mediterranean diet compliance score; Olive oil consumption; Vegetable consumption; Fruit consumption; Consumption of legumes; Consumption of nuts; Fish and aquatic consumption; Consuming sweet or carbonated drinks; Replacing red meat with chicken; Consumption of red meat and its products; Consuming sweets; Consumption of butter, margarine and cream; Use of seasonings and spices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240526061905N1
Registration date:2024-08-25, 1403/06/04
Registration timing:retrospective
Last update:2024-08-25, 1403/06/04
Update count:0
Registration date
2024-08-25, 1403/06/04
Registrant information
Name
Fatemeh Rahim Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 9179
Email address
rahimzadeh769@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-01-20, 1401/10/30
Trial completion date
2023-07-22, 1402/04/31
Scientific title
The effect of an educational intervention based on the Mediterranean diet on the modification of the dietary pattern of women with type 2 diabetes
Public title
Investigating the effect of an educational intervention based on the Mediterranean diet on the modification of the dietary pattern of diabetic women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of type 2 disease
Active case of care in comprehensive urban health service center
Taking blood sugar-lowering oral medications
Ability to participate in educational programs
Having literacy (at least fifth grade)
Willingness to participate in the intervention and complete the written informed consent form to participate in the study
Exclusion criteria:
Insulin injection
Having any physical or mental illness preventing participation in the intervention
Severe kidney and eye problems
pregnancy
being a smoker
Having another chronic disease at the same time
Using a special or prescribed diet
Incomplete completion of questionnaires
Unwillingness to continue cooperation
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Because the statistical population of this study, including middle-aged women with type 2 diabetes, were referring to comprehensive urban health service centers in Ilam city, the beginning of the study was done by referring to the management of the health center in Ilam city and providing an introduction letter to make the necessary arrangements to start the study. And multi-stage random sampling was done.
The health center of Ilam city has 10 comprehensive urban health service centers and 8 urban health centers that provide health services to the population under their coverage. In order to observe the homogeneity of the studied groups from the economic, social and cultural point of view, 2 comprehensive urban health service centers and 4 urban health centers on the edge of the city were excluded from the sampling. Then, comprehensive urban health service centers and urban health centers were checked in terms of location and classified into two groups: north (class A) and south (class B) and one center was selected from each group by lottery method, and these two centers were randomly assigned to intervention and control groups.
Then, according to the sample size of 62 people and the age standard of 30 to 59 years, non-random sampling was done in each center.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Banganjab, Pazhouhesh Blvd.
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MEDILAM.REC.1401.189
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
The Mediterranean diet compliance questionnaire mean score
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
2
Description
Olive oil consumption
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
3
Description
Vegetable consumption
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
4
Description
Consumption of fruits
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
5
Description
Consumption of red meat and its processed products
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
6
Description
Consumption of butter, margarine and cream
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
7
Description
Consuming sweet or carbonated drinks
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
8
Description
Consumption of legumes
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
9
Description
Consumption of fish and aquatic animals
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
10
Description
Consuming sweets
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
11
Description
Consumption of nuts
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
12
Description
Replacing red meat with chicken meat
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
13
Description
Use of seasonings and spices
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Mediterranean Diet Adherence Screener
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received an educational intervention based on what the Mediterranean diet is, the components of the Mediterranean diet, the benefits of the Mediterranean diet for edible food, the dos and don'ts of the Mediterranean diet, the food pyramid, how to cook and prepare food based on of this diet. Three two-hour face-to-face training sessions were held one day a week in the form of lectures for the intervention group, and part of the training content was provided to them in the form of booklets and pamphlets. During the intervention, reminder messages were used on messenger networks to strengthen the effect of education for the intervention group.
Category
Lifestyle
2
Description
Control group: They do not receive any intervention and only receive health care as before.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health service center number 4
Full name of responsible person
Ali Mohammad Khodayari
Street address
Emam Blvd.
City
Ilam
Province
Ilam
Postal code
6931853615
Phone
+98 84 3338 2215
Email
Rahimzadeh769@gmail.com
2
Recruitment center
Name of recruitment center
Comprehensive urban health service center number 10
Full name of responsible person
Mojtaba Shah Nazar
Street address
Mubarezan St
City
Ilam
Province
Ilam
Postal code
6931853615
Phone
+98 84 3338 2215
Email
Rahimzadeh769@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Naser Abbasi
Street address
Banganjab, Pazhouhesh Blvd.
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7140
Email
vcr@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristics, adherence to the Mediterranean diet, intake of food groups
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions, if conducting a similar study, can refer to the data of this work and use the necessary statistical analyzes without changing the data.
From where data/document is obtainable
Fatemeh Rahimzadeh with email address Rahimzadeh769@gmail.com
What processes are involved for a request to access data/document
Sending an email, explaining the reason for the request and how to use the documents, sending other permissions