Protocol summary

Summary
Current study will be performed in order to assess the impact of a multi-component school-based nutrition education program using PRECEDE-PROCEED model on improving nutritional status of primary school students. Study population are 302 children grades third to fifth in four regions of Shiraz whose height and weight are less than fifth of standard and do not suffer from any specific disease. The population will be allocated into two groups: case (151 persons) and control (151 persons) who will attend in educational classes that will be held by the executive of the project and/or educated health coaches of schools. The plan of nutrition education in this study is multi stage and includes these sections: specialized nutrition education for cases, education of the teachers and health coaches of the schools. After four months of completion of education course and registration of height, weight and the thickness of skin fold fat in students at the end of each month of education, the data will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014053117916N1
Registration date: 2014-06-29, 1393/04/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
Mahkameh Ashourpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ashourpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of a multi-component school-based nutrition education program using PRECEDE-PROCEED model on improving nutritional status of primary school students in Shiraz, Iran.
Public title
Impact of a multi-component school-based nutrition education program using PRECEDE-PROCEED model on improving nutritional status of primary school students.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for case and control groups: study in third to fifth grade in the four regions of Shiraz, Iran; height and weight less than 5th percentile of standard; not suffering from any specific disease. Exclusion criteria for case and control groups: diagnosis of a specific disease during the study; lack of cooperation; exclusion from the study because of any reason ( for example location change and ...).
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 302
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
CT-9378-7008

Health conditions studied

1

Description of health condition studied
Malnutrition
ICD-10 code
E40-46
ICD-10 code description
Malnutrition

Primary outcomes

1

Description
BMI
Timepoint
two weeks before and after the intervention
Method of measurement
W(kg)/H(cm2)

2

Description
height
Timepoint
two weeks before and after the intervention
Method of measurement
stadiometer

3

Description
weight
Timepoint
two weeks before and after the intervention
Method of measurement
digital scale

4

Description
skinfold measurement
Timepoint
two weeks before and after the intervention
Method of measurement
caliper

5

Description
dietary intake analysis
Timepoint
two weeks before and after the intervention
Method of measurement
questionnaire

6

Description
dietary habit
Timepoint
two weeks before and after the intervention
Method of measurement
questionnaire

7

Description
nutritional knowledge and attitude
Timepoint
two weeks before and after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
albumin
Timepoint
two weeks before and after the intervention
Method of measurement
ELISA

2

Description
transferin
Timepoint
two weeks before and after the intervention
Method of measurement
turbidimetty

3

Description
hemoglobin
Timepoint
two weeks before and after the intervention
Method of measurement
drabking

4

Description
quality of life
Timepoint
two weeks before and after the intervention
Method of measurement
questionnaire

Intervention groups

1

Description
a multi-component school-based nutrition education program using PRECEDE-PROCEED model the educational plan in multi-component and includes these parts: 1- specialized nutrition education for children of the case group, 2- education of mothers , 3- education of teachers and health instructors of the school, 4- education about offering healthy foods in school buffet
Category
Lifestyle

2

Description
control group receives educational booklets
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Elementary schools in the four regions of Shiraz
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mousa Salehi
Street address
Shiraz University of Medical Sciences, faculty of Nutrition and food Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahkameh Ashourpour
Position
PhD
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1002
Fax
Email
m.ashourpour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mousa Salehi
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1002
Fax
Email
salehi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahkameh Ashourpour
Position
PhD candidate
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1002
Fax
Email
m.ashourpour@yahoo.com ashourpour@sums.ac.ir
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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