Protocol summary

Summary
Objective: The purpose of this study is to investigate the effect of intervention based on precede proceed model on Health Nutritional Behavior of health volunteer in Rasht.Design: This study is a randomized controlled trial. Inclusion criteria: Being active as health volunteers in one of the health centers in Rasht; Attendance at weekly meetings contacts in health centers; Willingness to cooperate. Exclusion criteria: Not wanting to continue to work for any reason; the absence of more than two training session; and the absence of pre-test or post-test session.The sample size included 153 health active volunteers in health centers in Rasht. Urban health centers will allocate randomly into the intervention and control groups. Interventional group will receive the intervention based on precede proceed model, including: 32 training sessions will be held (each session 45-60 minutes lasts, for 8 subgroups, each group: 10 participants) by lectures, individual counseling, group discussions, role playing, rewarding and texting and also by applying leaflet, pamphlets, flyers, educational videos and PowerPoint slides. The control group will not receive any intervention by the researcher. Evaluations will conducted by precede proceed model in health nutritional behavior, before intervention and after 2 months. After the intervention, we expect significant progress in health nutritional behavior in the intervention group

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016050622984N3
Registration date: 2016-07-02, 1395/04/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Fardin Mehrabian
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 133335415
Email address
mehrabian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational intervention based on precede proceed model on health nutritional behavior of health volunteers
Public title
Promoting health nutritional behavior in health volunteers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Being active as health volunteers in one of the health centers in Rasht; Attendance at weekly meetings contacts in health centers; Willingness to cooperate. Exclusion criteria: Not wanting to continue to work for any reason; the absence of more than two training session; and the absence of pre-test or post-test session.
Age
From 24 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 153
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done using random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Guilan University of Medical Sciences
Street address
Office center of Guilan University of Medical Sciences, Parastar Street, Rasht, IRAN
City
Rasht
Postal code
4193713111
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
IR.GUMS.REC.1394.173

Health conditions studied

1

Description of health condition studied
health nutritional behavior
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
health nutritional behavior
Timepoint
pre intervention, 2 months after intervention
Method of measurement
Validated questionnaire of Precede Proceed Model

Secondary outcomes

1

Description
knowledge, attitude, enabling factors, reinforcing factors
Timepoint
pre intervention, 2 months after intervention
Method of measurement
Validated questionnaire of Precede Proceed Model

Intervention groups

1

Description
In interventional group: precede proceed model based intervention, including: 32 training sessions will be held (each session 45-60 minutes lasts, for 8 subgroups, each group: 10 participants) about increase knowledge about health nutritional behavior, in daily life and using training methods, including: lectures, individual counseling, group discussions, role playing, reward and texting and also by applying leaflet, pamphlets, flyers, educational videos and PowerPoint slides. Evaluations will conducted by precede proceed model, before intervention and after 2 months
Category
Behavior

2

Description
Control group: The control group will not receive any intervention by the researcher. Evaluations will conducted by precede proceed model, before intervention and after 2 months
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht Health Center
Full name of responsible person
Dr. Hojjat Najafzadeh
Street address
Saadi street, Rasht Health Center
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Dr Abtin Heidarzadeh
Street address
opposite of Sepah Bank, Shahid Beheshti Blvd, rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for Research, 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
Maryam Defaei Boueini
Position
MSc Student of Health Education and promotion
Other areas of specialty/work
Street address
School of Health, Resalat street, Rasht
City
Rasht
Postal code
4188794755
Phone
+98 13 3355 6856
Fax
Email
m_defaie_b@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
Dr. Fardin Mehrabian
Position
Associate Professor of Health Education and promotion
Other areas of specialty/work
Street address
School of Health, Resalat street, Rasht
City
Rasht
Postal code
4188794755
Phone
+98 13 3384 9412
Fax
Email
mehrabian@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Defaei Boueini
Position
MSc Student of Health Education and promotion
Other areas of specialty/work
Street address
School of Health, Resalat street, Rasht
City
Rasht
Postal code
4188794755
Phone
+98 13 3355 6856
Fax
Email
m_defaie_b@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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