Protocol summary

Study aim
Determining the effect of multimedia educational program based on health belief model on adherence to preventive behaviors of type 2 diabetes (diet and physical activity) in patients with prediabetes covered by comprehensive health service centers in Bushehr in 1399.
Design
A clinical trial with a control group, with parallel, randomized groups, on 78 patients. R software will be used.
Settings and conduct
The study will be performed on pre-diabetic patients in Bushehr Comprehensive Health Service Centers
Participants/Inclusion and exclusion criteria
• People with pre-diabetes (FBS =100-125 ) registered in the apple system whose test time is during recent one month. • Age 30 to 60 years • No pregnancy • Willingness to participate in the study • Be literate • Having a computer or tablet or smart phone and be familiar with working with it • Internet access • Do not have a chronic illness recorded in the person's electronic file or barrier for physical activity based on it. • The participant does not read the educational content at the specified time.
Intervention groups
Intervention groups receive educational content (based on the Health Belief Model) uploaded to the website by entering their username and password. The control group will be given a card containing a username and password to view the educational content along with a guide for using the website, after performing the final assessment in order to observe the ethics in the research.
Main outcome variables
FBS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200901048585N1
Registration date: 2020-09-25, 1399/07/04
Registration timing: prospective

Last update: 2020-09-25, 1399/07/04
Update count: 0
Registration date
2020-09-25, 1399/07/04
Registrant information
Name
sedh skenh basri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3354 8037
Email address
sh.basri63@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of multimedia educational intervention based on the Health Belief Model on Adherence to Preventive Behaviors of Type 2 Diabetes (Nutrition and Physical Activity) pre-diabetic patients
Public title
Effect of multimedia educational intervention based on the Health Belief Model on Adherence to Preventive Behaviors of Type 2 Diabetes (Nutrition and Physical Activity) pre-diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
• People with pre-diabetes (FBS =100-125) registered in the apple system whose test time belongs to recent 1 month. Age 30 to 60 years • No pregnancy • Willingness to participate in the study • literacy for reading and writing • Having a computer or tablet or smart phone and be familiar with working with it • Internet access • Do not have a chronic illness recorded in the person's electronic file or barrier on physical activity based on it.
Exclusion criteria:
• The participant does not view the educational content at the specified time.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Bushehr city has 10 comprehensive health service centers. In this study, initially, out of 10 comprehensive health service centers in Bushehr, 5 centers are selected as intervention groups and 5 centers as control groups. Blocking to balance the number of units allocated to study groups. In this study, the blocks are considered as dual blocks AB and BA) (A: intervention group and B: treatment group). For example, if the block sequence obtained randomly by lot is ABABBAABBA, after the list of centers, the first center to the intervention group (A), the second center to the control group (B) and .. and the last center Assigned to intervention group (A). Then, pre-diabetic eligible individuals from each center (28 in the control group and 28 in the intervention group) are included in the study. In each group, the number of samples selected from each center will be proportional to the number of people eligible to enter the center. At each center, a list of pre-diabetic names with initial entry criteria is extracted through the Apple system. Necessary samples are selected randomly and by simple method and lottery. By contacting these other people, the inclusion criteria (having a computer and smartphone, internet access) and the willingness to participate in the study are checked. In the absence of inclusion criteria, it was randomly replaced from the rest of the list.
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 Bushehr University of Medical Sciences
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Busher
Province
Boushehr
Postal code
7514633341
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.BPUMS.REC.1399.064

Health conditions studied

1

Description of health condition studied
Pre-diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
FBS
Timepoint
Before training and three months after training
Method of measurement
View FBS test results

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational content in this study, based on the constructs of the health belief model, is uploaded on the website after developing and people are asked to read the trainings for a maximum of 2 weeks.
Category
Behavior

2

Description
Control group: Routine training of health centers and after the final assessment to comply with research ethics, participants in the control group will be given a card containing a username and password to view the educational content along with a guide to using the website.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Comprehensive Health Service Centers
Full name of responsible person
Engineer Hassan Fakhraei
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3354 8037
Email
sh.basri63@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
BUSHER
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3354 8037
Email
sh.basri63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Raisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Busher
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3354 8037
Email
sh.basri63@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Raisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Busher
Province
Boushehr
Postal code
4175146333
Phone
+98 77 3354 8037
Email
sh.basri63@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Raisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Busher
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3354 8037
Email
sh.basri63@gmail.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
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
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