1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of nutritional education based on the precede-Proceed model and according to the food basket introduced by the Ministry of Health on improving the growth indicators and food intake of malnourished children aged 7-12 years

Protocol summary

Study aim
Determining the effect of nutritional education based on the PRECEDE-PROCEED model and according to the optimal food basket introduced by the Ministry of Health on improving the growth indicators and food intake of 7-12 year old children suffering from malnutrition in Kermanshah.
Design
The current study is a randomized controlled trial (clinical trial). Malnourished children aged 7 to 12 who meet the inclusion criteria are included in the study. After obtaining informed consent, 254 people were selected from among them and randomly divided into two intervention and control groups of 127 people.
Settings and conduct
This study will be conducted in primary schools of Kermanshah and on malnourished children. Malnourished children are identified using anthropometric indicators and growth monitoring charts, and they are enrolled and enrolled in the study considering the entry and exit criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to cooperate, suffering from mild, moderate and severe malnutrition (diagnosed using anthropometric assessments and growth percentiles), children's age in the range of 7 to 12 years, not using vitamin and mineral supplements, not having underlying, genetic diseases, acute gastrointestinal, respiratory infections, acute-chronic renal failure, active liver disease, red blood cell hemolysis, intestinal parasites, hyperactivity and attention deficit. Exclusion criteria: unwillingness to continue cooperation, hospitalization and accidents.
Intervention groups
127 malnourished children who are under nutrition education according to the PRECEDE- PROCEED model and according to the optimal food basket introduced by the Ministry of Health.
Main outcome variables
Average scores of predisposing factors, enhancing factors, enabling factors Average growth indices (height for age, weight for age, BMI for age)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181111041611N7
Registration date: 2023-07-25, 1402/05/03
Registration timing: prospective

Last update: 2023-07-25, 1402/05/03
Update count: 0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of nutritional education based on the precede-Proceed model and according to the food basket introduced by the Ministry of Health on improving the growth indicators and food intake of malnourished children aged 7-12 years
Public title
Investigating the effect of nutrition education on improving growth indicators and food intake in 7-12 year old children suffering from malnutrition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate Suffering from mild, moderate and severe levels of malnutrition Children's age ranges from 7 to 12 years Not using vitamin and mineral supplements Not having underlying, genetic diseases Absence of acute digestive and respiratory infections, acute-chronic renal failure, attention deficit
Exclusion criteria:
Unwillingness to continue cooperation Hospitalization Accidents
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 254
Randomization (investigator's opinion)
Randomized
Randomization description
The participants of this study from public and non-profit primary schools in Kermanshah city were identified by student using anthropometric indicators and growth monitoring charts, and taking into account the entry and exit criteria, they were registered and enrolled. Then, using block randomization method, they are divided into intervention and control groups. The size of the blocks is not equal and is chosen randomly, which can include 10 blocks of 20, 5 blocks of 10 and 2 blocks of 2, and there are equal numbers of each group A and B in each block. A): intervention group and B: control group) Random numbers are generated by the statistical consultant and the random allocation of people to two groups of intervention and control will be done by the project manager (supervisor) and the student is not aware of this allocation. Coded boxes will also be used to hide random sequences.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The current study is a randomized controlled trial (clinical trial) that will be conducted on 254 children aged 7 to 12 with malnutrition who are randomly divided into two groups of 127 intervention and control. The intervention group receives nutrition education and the control group does not receive any education.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.KUMS.REC.1402.137

Health conditions studied

1

Description of health condition studied
Malnutrition
ICD-10 code
E46
ICD-10 code description
Unspecified protein-calorie malnutrition

Primary outcomes

1

Description
Scores of predisposing factors including (score of awareness, attitude and self-efficacy), strengthening and enabling factors
Timepoint
Before the intervention, 1 month and 3 months after the intervention
Method of measurement
PRECEDE questionnaire

2

Description
height-for-age
Timepoint
before the intervention, 1 month and 3 months after the intervention
Method of measurement
WHO height-for-age chart

3

Description
weight-for-age
Timepoint
before the intervention, 1 month and 3 months after the intervention
Method of measurement
WHO weight-for-age chart

4

Description
BMI for age
Timepoint
Before the intervention, 1 month and 3 months after the intervention
Method of measurement
BMI chart for age WHO

5

Description
Food intake
Timepoint
Before the intervention, 1 month and 3 months after the intervention
Method of measurement
Food record questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 127 children aged 7 to 12 suffering from malnutrition in the city of Kermanshah who have been subjected to the intervention of an educational program that, according to the information of the initial questionnaire, educational needs assessment, prioritization of these educations and determination of educational goals are carried out and these educations can include group education food, healthy eating, food variety, meat substitutes, protein sources, food containing vitamins, minerals such as iron, calcium and zinc, the amount of daily body needs from food groups and how to prepare food according to the child's interest, which It will be prepared from each training session. The trainings are weekly for 2 months and each session lasts 45 to 60 minutes in the form of face-to-face lectures, group discussions, worksheets, questions and answers, and educational videos, which will be conducted in the presence of students, their parents, and teachers.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nasim Primary school
Full name of responsible person
Soraya Yazdani
Street address
Taleghani Ave, Shahid Square, Elahia
City
Kermanshah
Province
Kermanshah
Postal code
6719945671
Phone
+98 83 3836 9883
Email
fmaleki246@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ramin Ghasemi
Street address
Kermanshah Medical Sciences Central Building-Shahid Beheshti Boulevard-
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Email
sdrc@kums.ac.ir
Web page address
http://www.kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutritional Sciences, Faculty of Nutritional Sciences and Food Industry, Dowlatabad Blvd, Itsar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutritional Sciences, Faculty of Nutritional Sciences and Food Industry, Dowlatabad Blvd, Itsar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2009
Fax
Email
mehnoosh_samadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
NO. 20900, Shoukry Alley, Arak Blvd., Hamedan, Iran
City
Malayer
Province
Hamadan
Postal code
6571684913
Phone
+98 81 3228 4158
Email
fmaleki39@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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...