The aim of this study is to evaluate the effect of a nutrition education program on markers of iron status in adolescent girls with iron deficiency anemia (IDA).
Design
Clinical trial with control group، parallel groups, randomized,
Settings and conduct
176 adolescent girls living in Saravan, Sistan and Baluchestan province, who have iron deficiency anemia, will be randomly allocated into two groups of intervention and control. Adolescent girls will undergo training with computer games (intervention group) or receiving nutritional recommendations via PowerPoints and pamphlets (control group) for 14 weeks. Laboratory tests related to iron deficiency anemia and the knowledge, attitude and practice about Iron deficiency anemia will be measured at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adolescent girls (19-10 years old) who can use smart phone
Participants with this condition were not included in the study :
Having cardiovascular disease or other chronic diseases
severe monthly bleeding during menstruation
Having infection or fracture
Students who have been treated with iron supplements or other vitamin or mineral supplements during the study
Intervention groups
Adolescent girls in the intervention group will participate in a nutrition education program using an online game for 14 weeks, while those in the control group will only receive nutritional recommendations for Iron deficiency anemia (IDA).
Main outcome variables
Hemoglobin, ferritin, transferrin, serum iron, Total Iron Binding Capacity (TIBC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190610043857N1
Registration date:2019-06-30, 1398/04/09
Registration timing:retrospective
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Omid Sabetghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3763 1166
Email address
sayans194@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-12-11, 1397/09/20
Actual recruitment end date
2019-06-10, 1398/03/20
Trial completion date
2020-03-20, 1399/01/01
Scientific title
Evaluating the effect of digital game-based nutrition education on iron deficiency anemia indicators in adolescent girls
Public title
Effect of nutrition education on the status of iron deficiency anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescent girls (19-10 years old) who can use smart phones
Exclusion criteria:
Having Cardiovascular disease or other chronic diseases
Severe monthly bleeding during menstruation
Having Infection or Fractures
Students who have been treated with iron supplements or other vitamin or mineral supplements during the study
Age
From 10 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
176
Actual sample size reached:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized balanced block:
Eligible people will be randomly assigned into two groups: randomized block randomization will be done with a fixed block size of four.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Center building of Shiraz University of Medical Sciences , infront of felestin street, zand avenue, Shiraz.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
IR.SUMS.REC.1397.726
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia
Primary outcomes
1
Description
Ferritin
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
ELISA method
2
Description
Transferrin
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Calorimetry
3
Description
Hemoglobin
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Cell counter
4
Description
Serum Iron
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Calorimetry
5
Description
Total Iron Binding Capacity (TIBC)
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Calorimetry
Secondary outcomes
1
Description
Score of knowledge
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Questionnaire on Knowledge of Adolescent Girls about Iron Deficiency Anemia
2
Description
Height
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Stadiometer
3
Description
Weight
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Digital scale
4
Description
Score of attitude
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Questionnaire on attitude of adolescent girls about iron deficiency anemia
5
Description
Score of performance
Timepoint
Baseline and after 14 weeks of intervention
Method of measurement
Questionnaire on the performance of adolescent girls about iron deficiency anemia
Intervention groups
1
Description
Intervention group :Adolescent girl in the intervention group will participate in a nutrition education program using an online game for The 14 weeks. The computer game is consisted of seven different levels, in which each level will be opened every single week for students, so that the whole game will be played during the 14 weeks
Category
Lifestyle
2
Description
control group :Girls in the control group will receive only nutritional recommendations for iron deficiency anemia through PowerPoint and Pamphlet.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Secondary schools and high schools
Full name of responsible person
Omid sabetghadam
Street address
Shahid Rajaee street, Saravan city
City
Saravan
Province
Sistan-va-Balouchestan
Postal code
9951774497
Phone
+98 54 3763 1166
Email
sayans194@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Centeral buliding of Shiraz University of Medical Sciences, in front of Felestin avenue, Zand stree.
City
Shiraz
Province
Fars
Postal code
71348-14336
Email
Ghasemiy@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Omid sabetghadam
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences of Shiraz, Razi street, Modares Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
sayans194@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences of Shiraz, Razi street, Modares Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
Zahra_2043@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Omid Sabetghadam
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences of Shiraz, Razi street, Modares Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
sayans194@gmail.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
before publishing the article, we don't agree to share our results with others.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Until the publishing of the article, we wouldn't share any other data.
When the data will become available and for how long
after the publishing of the article and for an unlimited time
To whom data/document is available
for all people
Under which criteria data/document could be used
with considering the rights for the responsible person
From where data/document is obtainable
Results will be added to this part.
What processes are involved for a request to access data/document