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2.4. FUNDAMENTACIÓN TEORICA

2.4.3 ACCIDENTE OFÍDICO

175 (FORM 5.3)

Sultanate of Oman (Fish Group)

Ministry of Health- /Department of Studies & Research Research and Ethical Review & Approve Committee

Certificate of Informed Consent

Consent form of participating in the project: The impact of eating fish and fish oil on fatty acids (Omega-3), and perception of school students in the governorate of Muscat

Project goal:

Researchers have suggested that there is a close relationship between eating fish, especially rich in Omega-3 fatty acids and health in general. There is little knowledge about the potential impact of eating fish and health in the Sultanate of Oman. the goal of this project was to study the effect of local Omani fish consumption and seafood on the health and also on the level of perception, especially among school children.

The study will be conducted on 354 students in the age group 9-10 years (Grade 4) in three schools in Muscat governorate. Students will be distributed randomly into three groups, where one of them will consume fish and the other fish oil capsules while the third group remains neutral. Your son or daughter has been selected randomly to be in fish group and will be providing a fish meal for them 4 times a week for 4 months.

Their body composition, food intake will be evaluated by food frequency questionnaires, complete blood picture, blood lipids and iodine concentration in the urine through the use of established protocols. The school performance and attention will also be evaluating to both male / female student. All evaluations will be conducted at the beginning of the intervention and when it is completed.

How you can help?

Assent to join us where research will include:

Interview: We would like to ask some questions that will help us to fill the questionnaire;

176

Cognitive assessment: a questionnaire will be given to you about your child cognitive behavior, and another one will be filled by the class teacher.

Physical measurements: such as height, weight and measure the body fat percentage.

Physical fitness: a team from London will assess your child physical activity All of this will be done at school

Other clinical tests will be taken at the health centre:

Laboratory tests: such as a blood test, urine test, sample will be taken by taking into

account safety and hygiene measures.

We will send part of a sample of blood to the London Metropolitan University in Britain for analysis of fatty acids and antioxidant vitamins under the approval of the Research Ethics Committee, which were obtained from a national committee in the UK health service.

Personal data will be dealing in the strictest confidence and will not be used for any other purpose and not be transferred to others without the written consent of the parents of the students. All the data collected from this study will store in a password-protected computer and access will be limited to researchers.

Please note this study will be conducted under full compliance with the principles of data protection law. You are free to withdraw from the study at any time without giving any reason.

Is there any benefit derived for others?

This study will help us to assess the relationship between dietary sources of fatty acids and its potential health and the level of awareness among school students.

What if you do not want to share my son / daughter in the project?

This would not constitute any difference in our dealings with you; you will always get the best deal possible.

177 Recognition

I certify that I have read and understood the information pertaining to study above. I understand that my participation is voluntary and that I have absolute freedom to withdraw at any time without affecting me or my son / daughter.

I agree to participate in the study

Participant'sname Date Signature

178 (FORM 5.3)

Sultanate of Oman

(Omega-3 capsules Group)

Ministry of Health- / Department of Studies & Research

Research and Ethical Review & Approve Committee

Certificate of Informed Consent

Consent form of participating in the project: The impact of eating fish and fish oil on fatty acids (Omega-3), and perception of school students in the governorate of Muscat

Project goal:

Researchers have suggested that there is a close relationship between eating fish, especially rich in Omega-3 fatty acids and health in general. There is little knowledge about the potential impact of eating fish and health in the Sultanate of Oman. the goal of this project was to study the effect of local Omani fish consumption and seafood on the health and also on the level of perception, especially among school children.

The study will be conducted on 354 students in the age group 9-10 years (Grade 4) in three schools in Muscat governorate. Students will be distributed randomly into three groups, where one of them will consume fish and the other fish oil capsules while the third group remains neutral. Your son or daughter has been selected randomly to be in a fish oilcapsule

group which containing200 gofDHA 4times a weekforaperiodof4 months. Their body composition, food intake will be evaluated by food frequency questionnaires, complete blood picture, blood lipids and iodine concentration in the urine through the use of

established protocols. The school performance and attention will also be evaluating to both male / female student. All evaluations will be conducted at the beginning of the intervention and when it is completed.

How you can help?

Assent to join us where research will include:

Interview: We would like to ask some questions that will help us to fill the questionnaire:

24 hour reall questionnaire will be used to assess your child dietary intake.

Cognitive assessment: a questionnaire will be given to you about your child cognitive

179 Physical measurements: such as height, weight and measure the body fat percentage. Physical fitness: a team from London will assess your child physical activity

All of this will be done at school

Other clinical tests will be taken at the health centre:

Laboratory tests: such as a blood test, urine test, sample will be taken by taking into

account safety and hygiene measures.

We will send part of a sample of blood to the London Metropolitan University in Britain for analysis of fatty acids and antioxidant vitamins under the approval of the Research Ethics Committee, which were obtained from a national committee in the UK health service.

Personal data will be dealing in the strictest confidence and will not be used for any other purpose and not be transferred to others without the written consent of the parents of the students. All the data collected from this study will store in a password-protected computer and access will be limited to researchers.

Please note this study will be conducted under full compliance with the principles of data protection law. You are free to withdraw from the study at any time without giving any reason.

Is there any benefit derived for others?

This study will help us to assess the relationship between dietary sources of fatty acids and its potential health and the level of awareness among school students.

What if you do not want to share my son / daughter in the project?

This would not constitute any difference in our dealings with you; you will always get the best deal possible.

180 Recognition

I certify that I have read and understood the information pertaining to study above. I understand that my participation is voluntary and that I have absolute freedom to withdraw at any time without affecting me or my son / daughter.

I agree to participate in the study

Participant'sname Date Signature

181 (FORM 5.3)

Sultanate of Oman (Control Group)

Ministry of Health- / Department of Studies & Research

Research and Ethical Review & Approve Committee

Certificate of Informed Consent

Consent form of participating in the project: The impact of eating fish and fish oil on fatty acids (Omega-3), and perception of school students in the governorate of Muscat

Project goal:

Researchers have suggested that there is a close relationship between eating fish, especially rich in Omega-3 fatty acids and health in general. There is little knowledge about the potential impact of eating fish and health in the Sultanate of Oman. the goal of this project was to study the effect of local Omani fish consumption and seafood on the health and also on the level of perception, especially among school children.

The study will be conducted on 354 students in the age group 9-10 years (Grade 4) in three schools in Muscat governorate. Students will be distributed randomly into three groups, where one of them will consume fish and the other fish oil capsules while the third group remains neutral. Your son or daughter has been selected randomly to beintheneutralgroup

so he/she will notreceivefish mealorfishoilcapsules. Their body composition, food intake

will be evaluated by food frequency questionnaires, complete blood picture, blood lipids and iodine concentration in the urine through the use of established protocols. The school performance and attention will also be evaluating to both male / female student. All

evaluations will be conducted at the beginning of the intervention and when it is completed.

How you can help?

Assent to join us where research will include:

Interview: We would like to ask some questions that will help us to fill the questionnaire

24 hour reall questionnaire will be used to assess your child dietary intake.

Cognitive assessment: a questionnaire will be given to you about your child cognitive

182 Physical measurements: such as height, weight and measure the body fat percentage. Physical fitness: a team from London will assess your child physical activity

All of this will be done at school

Other clinical tests will be taken at the health centre:

Laboratory tests: such as a blood test, urine test, sample will be taken by taking into

account safety and hygiene measures.

We will send part of a sample of blood to the London Metropolitan University in Britain for analysis of fatty acids and antioxidant vitamins under the approval of the Research Ethics Committee, which were obtained from a national committee in the UK health service.

Personal data will be dealing in the strictest confidence and will not be used for any other purpose and not be transferred to others without the written consent of the parents of the students. All the data collected from this study will store in a password-protected computer and access will be limited to researchers.

Please note this study will be conducted under full compliance with the principles of data protection law. You are free to withdraw from the study at any time without giving any reason.

Is there any benefit derived for others?

This study will help us to assess the relationship between dietary sources of fatty acids and its potential health and the level of awareness among school students.

What if you do not want to share my son / daughter in the project?

This would not constitute any difference in our dealings with you; you will always get the best deal possible.

183 Recognition

I certify that I have read and understood the information pertaining to study above. I understand that my participation is voluntary and that I have absolute freedom to withdraw at any time without affecting me or my son / daughter.

I agree to participate in the study

Participant'sname Date Signature

196

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