Protocol summary

Summary
This study aimed at assessing the effectiveness of educational intervention to promote healthy nutritional behavior in women aged 20-49, six months after intervention. Inclusion criteria: Healthy women aged 20-49 without special diet; residing in Tehran; referring to Homes Health and Neighborhood Houses and consent to participation in study. Exclusion criteria: Having special diet. Population study is healthy women aged 20-49 living in Tehran that are referring to Homes Health and Neighborhood Houses. Sample size is 110; 105 in intervention group and 105 in control group. In intervention group, the following measures will be done: holding educational classes in order to increase social support, self-efficacy, self-regulation and educational of healthy nutritional behavior included Increase consumption of fruit and vegetables, decrease consumption of fat, sugar and Foods high in salt for women. The time of study will be from 2015/8/8 to 2016/3/5. Outcome of study: promoting healthy nutritional behavior in women.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042512460N6
Registration date: 2015-05-03, 1394/02/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-08-08, 1394/05/17
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluating impact of an educational program to promote healthy nutritional behavior in 20-49 year- old women
Public title
Evaluation of an educational program to promote healthy nutritional behavior in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy women aged 20-49 without special diet; residing in Tehran; referring to Homes Health and Neighborhood Houses and consent to participation in study Exclusion criteria: Having special diet.
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A cross sectional study will be done before the intervention. In second stage of the study, 22 regions of Tehran will be divided into 5 regions: north, south, east, west and center. From each region one center will be selected as intervention group and one as control group randomly and samples will be devided between centers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical sciences
Street address
Main building of Tehran University of Medical sciences
City
Tehran
Postal code
Approval date
2015-01-17, 1393/10/27
Ethics committee reference number
131264- 8921108011

Health conditions studied

1

Description of health condition studied
Factors influencing health status and contact with health services
ICD-10 code
Z00-Z99
ICD-10 code description
افراد در معرض خطر بیماری های غیر واگیر

Primary outcomes

1

Description
Healthy nutritional behavior in women
Timepoint
Before and 6 months after the intervention
Method of measurement
Healthy nutritional behavior questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group, the following measures will be done: holding educational classes in order to increase social support, self-efficacy, self-regulation and educational of healthy nutritional behavior included Increase consumption of fruit and vegetables, decrease consumption of fat, sugar and Foods high in salt for women.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Homes Health and Neighborhood Houses, Tehran
Full name of responsible person
Samaneh zamani
Street address
Golha Square, Shahid Gomnam Highway, Before Kordestan Highway, Culture and Art Organization of Tehran Municipality
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Educational vice chancellor of Tehran University of Medical Scirnces
Full name of responsible person
Dr.Mohammad Jalili
Street address
Main building of Tehran University of Medical Scirnces
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Educational vice chancellor of Tehran University of Medical Scirnces
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
Department of Health Education and Promotion, School of Public Health, Tehran University of Medical
Full name of responsible person
Maryam Mohammadi Nasrabadi
Position
PhD(Health Education and Health Promotion) candidate
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health, Poursina Ave., Qods Ave
City
Tehran
Postal code
Phone
+98 21 8859 9888
Fax
Email
m.mohammadinasr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Phd- Member of Scientific Board
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health, Poursina Ave., Qods Ave.
City
Tehran
Postal code
Phone
+98 21 8859 9888
Fax
Email
Sadeghir@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Health Education and Promotion, School of Public Health, Tehran University of Medical
Full name of responsible person
Maryam Mohammadi Nasrabadi
Position
PhD(Health Education and Health Promotion) candidate
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health, Poursina Ave., Qods Ave
City
Tehran
Postal code
Phone
+98 21 8859 9888
Fax
Email
m.mohammadinasr@yahoo.com
Web page address

Sharing plan

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