Protocol summary

Summary
This study investigated the effect of health belief model-based educational intervention on nutritional function of rural women with stomach cancer in the city of Talesh in 2017. It was a randomized controlled field trial, performed in several stages. The first phase of sampling used simple random sampling method and the second phase used systematic random sampling method. Data were collected using a four-section questionnaire, including: demographic information, knowledge assessment, health belief model constructs and performance measurement. Inclusion criteria included: willingness to participate in the program, women aged between 18 and 60 years, no history of stomach cancer in the subjects, their spouses or their first-degree female relatives and being literate. Exclusion criteria included: quitting training sessions and changing the respective center. The informed written consent was obtained. Based on the results of the first stage, the predictive constructs, appropriate educational methods and studies conducted by the author and the co-author, the educational intervention was conducted in six 40-50 minutes sessions, using the following methods: lecture, participatory and activation methods, question and answer session, group discussion and brainstorming method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062319235N5
Registration date: 2017-08-05, 1396/05/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Parisa Kasmaei
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 2772
Email address
parisa_kasmaei@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on the Health Belief Model in nutritional behaviors associated with gastric cancer in rural women
Public title
The effect of educational intervention based on the Health Belief Model in nutritional behaviors associated with gastric cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the program; women aged between 18 and 60 years, no history of stomach cancer in the subjects; their spouses or their first-degree female relatives and being literate. Exclusion criteria: quitting training sessions and changing the respective center.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Research and Technology Section of Guilan University of Medical Sciences
Street address
Shahid Beheshti Blvd.(west), opposite of Sepah Bank, vice-chancellor for Research Building
City
Rasht
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.GUMS.REC.1396.109

Health conditions studied

1

Description of health condition studied
cancer of stomach
ICD-10 code
C16, C16.0
ICD-10 code description
Malignant neoplasm of stomach, Cardia (Cardiac orifice, Cardio-oesophageal junction, Gastro-oesophageal junction, Oesophagus and stomach), Fundus of stomach, Body of stomach, Pyloric antrum (Gastric antrum), Pylorus (Prepylorus, Pyloric canal), Lesser cur

Primary outcomes

1

Description
Nutritional behaviors associated with gastric cancer
Timepoint
Before and two months after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The study investigated the effect of health belief model-based educational intervention on nutritional function of stomach cancer patients. First, the pre-test was conducted on selected subjects and then the educational intervention was conducted in six 40-50 minutes sessions, using the following methods: lecture, participatory and activation methods, question and answer session, group discussion and brainstorming method.
Category
Prevention

2

Description
No intervention was conducted for the control group and two months after the pre-test, the post-test was conducted.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Talesh rural Health Centers
Full name of responsible person
Street address
City
Talesh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Section of Guilan University of Medical Sciences
Full name of responsible person
Dr Shademan Nemati
Street address
Shahid Beheshti Blvd.(west), opposite of Sepah Bank, vice-chancellor for Research Building
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Section of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Anvar Shilan
Position
MSc Student of Education Health
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 3384 9411
Fax
Email
shilan201291@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Parisa Kasmaei
Position
PhD of health education
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences
City
Rasht
Postal code
4193893345
Phone
+98 13 3336 2772
Fax
Email
parisa_kasmaei@gums.ac.ir; parisak81@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Anvar Shilan
Position
MSc Student of Education Health
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 3384 9411
Fax
Email
shilan201291@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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