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The effect of an educational intervention on reducing the consumption of high-fat foods in women referred to the health houses in Tehran

Protocol summary

Study aim
Determine the effect of an educational intervention on reducing the consumption of high-fat foods in women referred to the health houses in Tehran
Design
In total, Tehran has 354 health homes (affiliated to Tehran municipal). From each of the four districts of Tehran city (including north, south, east and west), one health home will be randomly selected by simple sampling methods. Then, 23 female referring to each health homes will be selected and randomly assigned to the control and the intervention group.
Settings and conduct
Setting: Health Houses of Tehran (affiliated to Tehran municipal). Conduct: Ninety two female referring to 4 health homes will be selected and randomly assigned to the control and the intervention group. The two groups completed the questionnaires. Educational intervention will be developed based on the pretest results. By face to face meetings, participants in the intervention group will be received education intervention. Educational media such as pamphlets will be given the participants. Two months after the intervention, the two groups will be followed and completed the questionnaires again. Finally, the data will be analyzed by SPSS software .
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Literacy ≥ 5 grade - Being female Exclusion criteria: - History of diseases that limit lipid consumption (such as diabetes, cardiovascular, blood pressure, kidney, fatty liver) - History of consumption of lipid lowering medications
Intervention groups
Intervention group: Face to face education in the field of high fat foods and reducing it consumption during 4 weeks was provided. Also, educational media such as pamphlets, posters, etc was given to the participants. Control group: No intervention
Main outcome variables
Reducing high-fat foods consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110727007132N19
Registration date: 2019-11-03, 1398/08/12
Registration timing: retrospective

Last update: 2019-11-03, 1398/08/12
Update count: 0
Registration date
2019-11-03, 1398/08/12
Registrant information
Name
Tahereh Dehdari
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 2188779118263
Email address
t-dehdari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
The effect of an educational intervention on reducing the consumption of high-fat foods in women referred to the health houses in Tehran
Public title
The effect of an educational intervention on reducing the consumption of high-fat foods in women referred to the health houses in Tehran
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy ≥ 5 grade Being female
Exclusion criteria:
History of diseases that limit high-fat foods consumption (such as diabetes, cardiovascular, blood pressure, kidney, fatty liver)- History of consumption of lipid lowering medications History of consumption of blood lipid lowering medications
Age
From 19 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Actual sample size reached: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The list of 354 Health Houses (affiliated to Municipal of Tehran) in the 4 regions including north, south, east and west of Tehran city at the moment of the study is available to the researchers. One Health Home will be randomly selected by simple sampling methods (Lottery method) from each region. Then, among female referred during a day to each health home, 23 female will be selected by simple sampling. The first person to visit of the Health House will be randomly assigned to the intervention group. The second person will be randomly assigned to the control group. The third person well be assigned to the intervention group. Similarly, the allocation of the remaining subjects will be continued in two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There is no special characteristic in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences and Health Services Ethics ComComittee of Ir
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1177

Health conditions studied

1

Description of health condition studied
high-fat diet
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Consumption of high-fat foods
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reducing high- fat foods consumption
Timepoint
Before and two months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving educational intervention including three face- to- face sessions during 3 weeks (in terms of awareness of type of lipids, the methods of reducing the rate of lipid of foods, attitude toward less high-fat foods consumption and less use of high-fat foods daily) and educational media such as booklet
Category
Lifestyle

2

Description
Control group: Not received any educational intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Houses in Tehran
Full name of responsible person
Zainab Nasiri
Street address
The Intersection of the Martyred Freeway, Kurdistan Highway
City
Tehran
Province
Tehran
Postal code
1438614151
Phone
+98 21 9602 1651
Fax
+98 21 8431 2405
Email
salamat-egtemaei@tehran.ir
Web page address
http://farhangi.tehran.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Person (Miss Fatemeh Zeinalzadeh Bruji)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Email
dehdarit@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Email
dehdarit@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Email
dehdarit@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The results only will be published in the article
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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