Protocol summary

Study aim
To determine the effect of the theory-centered education on the promotion of healthy lifestyle in pre-diabetic women
Design
The present study was conducted on a control-controlled educational intervention in about 104 pre-diabetic people referring to comprehensive health centers in Arak city (in two groups of control and control, each of 52). Thus, residents of Arak city according to the opinion of the staff of the deputy Health is divided into four classes based on the socioeconomic status. Then, from each of the two health centers, it is selected randomly, so that the selected center belongs to the test group and the second center selected belongs to the control group, so in total 4 centers are assigned to the test group and 4 centers to the control group, and samples are from each The center is available for selection.
Settings and conduct
Steps: Measurement of fasting blood glucose Perform pre-test by distributing the questionnaire Educational content development Educational intervention for intervention group Perform post-test by redistributing the questionnaire three months after the intervention Measurement of fasting blood glucose after intervention Place:arak health care centers
Participants/Inclusion and exclusion criteria
Entry requirements: having a minimum fifth degree of primary education, a person's willingness to participate in research, a fasting blood sugar level of more than 100 and less than 125, age from 30 to 59 years
Intervention groups
Control group: receive routine training Test group: Suitable training programs are received for structured models of planned behavior.
Main outcome variables
Prevent diabetes and its complications, having healthy and effective lives in society

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190304042921N1
Registration date: 2019-07-22, 1398/04/31
Registration timing: prospective

Last update: 2019-07-22, 1398/04/31
Update count: 0
Registration date
2019-07-22, 1398/04/31
Registrant information
Name
Kolsoum Mohammadniamothagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 6443
Email address
k.mohammadniya@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the theory-based education on promoting healthy lifestyle in pre-diabetic women referring to arak health care centers
Public title
The effect of the theory-based education on promoting healthy lifestyle in pre-diabetic women referring to arak health care centers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a fifth grade elementary level of education a person's willingness to participate in research a fasting blood sugar level of more than 100 and less than 125 age from 30 to 59 years
Exclusion criteria:
exclusion criteria is women are not willing to participate in this research
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: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Residents of Arak city according to the opinion of the staff of the deputy health department are divided according to the socioeconomic status in the four classes. These four categories include centers with a population of almost good (5 centers), medium (3 centers), medium-low (2 centers) and poor (4 centers). Then, from each secondary health center, a simple random selection is made, so that the selected center belongs to the test group and the second center selected belongs to the control group, so in total 4 centers are assigned to the test group and 4 centers to the control group and samples from each center Available at affordable prices. The number of samples selected from each center is also 6 in each group. Random unit: cluster Randomization tool: SPSS software Hiding allocation concealment: The name of the comprehensive health center is hidden to the person who carries out randomization.
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 Arak University of Medical Sciences
Street address
Department of Research and Technology,University of the Great Prophet,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2019-06-02, 1398/03/12
Ethics committee reference number
IR.ARAKMU.REC.1398.073

Health conditions studied

1

Description of health condition studied
Pre-diabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test

Primary outcomes

1

Description
Healthy lifestyle (behavior)
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Knowledge
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

2

Description
Attitude
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

3

Description
Intention
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

4

Description
Subjective norms)
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

5

Description
Perceived behavioral control
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

6

Description
Fasting blood sugar
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
questionnaire

7

Description
Body mass index
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Tools

Intervention groups

1

Description
Intervention group: Preventive training programs will be developed to promote a healthy lifestyle (including healthy eating, physical activity, non-smoking, or hookah) and lowering blood glucose levels. The number of sessions and the content of the training and its duration will be determined after the need-assessment.
Category
Prevention

2

Description
Control group: The control group does not receive any training during the study.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Health Center
Full name of responsible person
Saeed Mohammad Doost
Street address
Phase Two,Shahid Beheshti Town,Arak
City
Arak
Province
Markazi
Postal code
۳۸۱۸۱۴۶۸۵۱
Phone
+98 86 3313 9037
Email
behdasht@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
ِDr. Alireza Kamali
Street address
Prophet's University Complex, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3639
Fax
+98 86 3417 3639
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Kolsoum Mohammadniamothagh
Position
Masters student Health Education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ground Floor,Building No. 2,Golestan koy,Mustafa Khomeini Town
City
Arak
Province
Markazi
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
k.mohammadniya@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Kolsoum Mohammadniamothagh
Position
Masters student Health Education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ground Floor,Building No. 2,Golestan koy,Mustafa Khomeini Town
City
Arak
Province
Markazi
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
k.mohammadniya@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Kolsoum Mohammadniamothagh
Position
Masters student Health Education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ground Floor,Building No. 2,Golestan koy,Mustafa Khomeini Town
City
Arak
Province
Markazi
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
k.mohammadniya@arakmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...