Conceptos de comunidad

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Appendix III: Patient Information Leaflet and Consent Certificate

79 POTENTIAL BENEFITS

If your child has albuminuria or hypertension, it will be detected early with early referral for appropriate care and follow up. The results of this study may help strengthen individual and community action to deal with this potentially modifiable risk factor for cardiovascular and renal diseases.

RISKS

The risk of this study to your child is not beyond the inconvenience of providing a urine sample in a specimen container. No repercussion afterwards.

RIGHTS

You have the right to ask questions on any aspect of the study that is unclear to you before your child participates and you have the right to withdraw from the study at any time without any consequence.

CONFIDENTIALITY

I will keep the records of this study confidential. All the information about your child will be coded so that names and other personal identification will not be used and will be available only to the researcher and research assistants.

QUESTIONS-WHO TO CALL

If you want any clarifications please call: The Chairman, LUTH’S ETHICAL COMMITTEE OR DR NWAOGAZIE UCHE on 08068613173.

CONSENT

By signing this consent form, you agree that your child should be part of the study.

80 CONSENT CERTIFICATE

I………consent to participate in the above named research study being conducted by Dr.NWAOGAZIE UCHE from Paediatrics department, Lagos University Teaching hospital, Idi-Araba, Lagos.

I have been given the following information:

1. That this study is undertaken to determine the prevalence and factors associated with albuminuria in obese and overweight adolescents in Surulere Local Government Area of Lagos State.

2. That albuminuria screening, anthropometry and blood pressure measurements will be done on my child.

3. That I will bear no cost of investigation.

4. That my child is at no risk by participating in this study.

5. That this study will contribute to knowledge and provide insights into the renal and cardiovascular complications of obesity and overweight in our environmnent.

6. That the information obtained from me will be treated as priviledged and confidential.

7. That I have the right to ask for clarifications on any aspect of the study that is unclear to me.

8. That I am guaranteed the right to withdraw my child from this study at any time.

……….. ………

Signature/thumb print Date

Note: please if you have any questions contact- DR Nwaogazie Uche,

Department of Paediatrics,

Lagos University Teaching Hospital.

E-mail address: [email protected] Phone number: 234-8068613173

OR

LUTH Health Research and Ethics Committee Room 107, Administrative block,

LUTH, Idi-Araba.

Phone: 234-1-5852187, 5852187

81 STATEMENT OF INFORMED CONSENT FOR CONTROLS

TITLE: PREVALENCE AND FACTORS ASSOCIATED WITH ALBUMINURIA IN OBESE AND OVERWEIGHT ADOLESCENTS IN AN URBAN AREA OF LAGOS STATE.

INVESTIGATOR: DR NWAOGAZIE UCHE EZIAKU

I will like your child/ward to be a part of a research study to be conducted in secondary schools in Surulere Local Government Area. Before you decide, I want you to know why I am carrying out the study and how it may benefit you and your child. Participation is not compulsory. If you choose not to participate you can opt out of the study at any time.

INTRODUCTION

Obesity is a worldwide problem; affecting both children and adults alike. Obesity has many complications. It can affect the bones, the heart, blood vessels and kidney. These complications have been shown to occur not only in adults but in children and adolescents alike. An evidence of kidney, heart and blood vessel problems in obesity is a protein called albumin in the urine. This protein appears early in the urine and thus can be detected early so that appropriate treatment can be given to those affected.

PURPOSE OF THE STUDY

This study is proposed to determine how common albuminuria is in obese and overweight children, and the factors associated with it in Surulere Local Government Area of Lagos State. Your child is being included as a control (a normal weight child who will be compared to children who are obese and or overweight).

PROCEDURE

Your child will be requested to provide about 10 milliliters of urine which will be tested for albuminuria. His/her weight, height, waist circumference and blood pressure will also be measured.

The study will include the use of a questionnaire and some personal and health related questions will be asked. The test will be at no cost to you. The test results will be communicated to you if you wish to have them.

82 POTENTIAL BENEFITS

If your child has albuminuria or hypertension, it will be detected early with early referral for appropriate care and follow up. The results of this study may help strengthen individual and community action to deal with this potentially modifiable risk factor for cardiovascular and renal diseases.

RISKS

The risk of this study to your child is not beyond the inconvenience of providing a urine sample in a specimen container. No repercussion afterwards.

RIGHTS

You have the right to ask questions on any aspect of the study that is unclear to you before your child participates and you have the right to withdraw from the study at any time without any consequence.

CONFIDENTIALITY

I will keep the records of this study confidential. All the information about your child will be coded so that names and other personal identification will not be used and will be available only to the researcher and research assistants.

QUESTIONS-WHO TO CALL

If you want any clarifications please call: The Chairman, LUTH’S ETHICAL COMMITTEE OR DR NWAOGAZIE UCHE on 08068613173.

CONSENT

By signing this consent form, you agree that your child should be part of the study.

83 CONSENT CERTIFICATE

I………consent to participate in the above named research study being conducted by Dr.NWAOGAZIE UCHE from Paediatrics department, Lagos University Teaching hospital, Idi-Araba, Lagos.

I have been given the following information:

9. That this study is undertaken to determine the prevalence and factors associated with albuminuria in obese and overweight adolescents in Surulere Local Government Area of Lagos State.

10. That albuminuria screening, anthropometry and blood pressure measurements will be done on my child.

11. That I will bear no cost of investigation.

12. That my child is at no risk by participating in this study.

13. That this study will contribute to knowledge and provide insights into the renal and cardiovascular complications of obesity and overweight in our environmnent.

14. That the information obtained from me will be treated as priviledged and confidential.

15. That I have the right to ask for clarifications on any aspect of the study that is unclear to me.

16. That I am guaranteed the right to withdraw my child from this study at any time.

……….. ………

Signature/thumb print Date

Note: please if you have any questions contact- DR Nwaogazie Uche,

Department of Paediatrics,

Lagos University Teaching Hospital.

E-mail address: [email protected] Phone number: 234-8068613173

OR

LUTH Health Research and Ethics Committee Room 107, Administrative block,

LUTH, Idi-Araba.

Phone: 234-1-5852187, 5852187

84