PLAIN LANGUAGE STATEMENT AND CONSENT FORM

TO: Participants Plain Language Statement Date: Full Project Title: Mobile App to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women Principal Researchers: Associate Professor Lynn Riddell, Professor Caryl Nowson, Dr Alison Booth, Dr Ewa Szymlek-Gay, Dr Linda Byrne, Manuela Rigo Associate Researcher: Karen Lim Student Researcher: Feifei Hu

This Plain Language Statement is 4 pages long; with the blank pages and forms the whole document is 8 pages long. Please make sure you have all the pages.

1.

Your Consent

You are invited to take part in this research project. Please read this Plain Language Statement carefully. Feel free to ask questions about any information in the document. You may also wish to discuss the project with a relative or friend or your local health worker. Feel free to do this. Once you understand what the project is about and if you agree to take part in it, you will be asked to sign the Consent Form on page 6. By signing the Consent Form, you indicate that you understand the information and that you give your consent to participate in the research project. You will be given a copy of the Plain Language Statement to keep as a record.

2.

Purpose and Background

The purpose of this project is to look at dietary and lifestyle behaviours that may affect iron and zinc levels in the body, and how iron and zinc levels impact on mood, stress, fatigue and concentration. The findings of this study will help to develop health promotion strategies to improve health of young women low in iron. It is unknown how much the amount of iron and zinc you have in your body is influenced by how much you eat and other lifestyle behaviours. We also dont know how much your iron and zinc levels affect your ability to concentrate, complete tasks, and your feelings of fatigue,
Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 1 of 8

depression and stress. The goal of this research is to look at dietary and lifestyle behaviours that influence iron and zinc intake and their levels in the body, and their impact on some measures of health. We also aim to identify women that we can invite to take part in a dietary study looking at ways to improve iron and zinc intake. You are invited to participate in this research project because you are a young woman, you are not pregnant or breastfeeding and have not been in the past 12 months, and you have not donated blood in the past 12 months.

3.

Funding

This research is funded by Deakin University and Meat & Livestock Australia Ltd.

4.

Procedures

The study will involve completing some questionnaires in your own time (approximately 60 minutes), two visits with researchers (approximately 60 minutes for the first one, and 15 minutes for the second one), and one visit to a local Dorevitch pathology centre for a blood test. The researchers will come to your school campus for the visits, and will inform you in advance. The questionnaires can be completed on line or in hard copies, depending on your personal choice. The questionnaires will ask about: 1) Your demographic information (like age, place of birth), your health, smoking and alcohol behaviours, and blood loss such as your period, use of contraception, and nose bleeds; 2) The types of food you eat; 3) The food and drink you consume on a usual day; 4) How much exercise and walking you do; and 5) Your sleep quality, mood and feelings of fatigue. Measurements We will measure your: 1. Weight, height, waist circumference and blood pressure; 2. Concentration and memory. The measurements take about 50 minutes, and we will collect and check for completeness of the questionnaires issued prior to your visit which will take about 10 minutes. Blood test You will be asked to visit a local Dorevitch pathology service centre thats convenient to you for a blood test (testing will be prepaid and organised by the researchers).We will ask you not to eat or drink for 10 hours overnight before providing the blood sample. A trained staff member at the pathology centre will collect 40 mL of blood (about 2 tablespoons) from a vein in your arm. The blood will be tested for substances in your blood that indicate the level of iron in your body. Second visit for Delivering Results The second visit is to advise you of your iron status. If your blood test indicates iron deficiency anaemia, we will recommend that you take a copy of your results and show your
Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 2 of 8

general practitioner. If your blood test indicates that the level of iron in your body is a bit low, but not deficient and if you also have an Android phone or an iPhone, we will invite you to participate in a study looking at using mobile phone apps to improve eating habits. Participation in this research project is voluntary and you are not obliged to take part in this study. In the future, we will analyse the stored blood sample for zinc, risk factors of cardiovascular disease, inflammation, and other markers of iron status.

5.

Possible Benefits

We cannot guarantee or promise that you will receive any benefits from this project but you will receive information on your iron levels.

6.

Possible Risks

Providing the blood sample, carries a small risk of discomfort and bruising and it is possible that you may feel lightheaded and even faint.

7.

Privacy, Confidentiality and Disclosure of Information

Any information obtained in connection with this research project that can identify you will remain confidential and will only be used for the purpose of this research project. All collected information will be labelled with a unique study code and not with your name or any other identifying information. Your personal identifying details will be kept separate from the information collected. All paper copies of this information will be kept in a locked filing cabinet in the researchers office at Deakin University or will be converted to digital files and then saved on a password protected computer. All digital information collected via online questionnaires will be saved by researchers on a password protected computer at Deakin University. Only researchers involved in this project will have access to this information. The information collected during this study will be kept until the end of the project and then placed in archives for seven years from the date of publication of summary findings. It is possible that in the future we may like to contact you again to see if you would like to participate in future studies. If you consent to being contacted in the future, please tick the box on the consent form below.

8.

Results of Project

The results of this study will only be presented in a summary form of all participants, thus individual results will not be identified. The study results will also be presented at key national and international conferences, and will appear in our annual reports and newsletters, including Meat & Livestock Australia newsletters and scientific journals. Some of the findings of this study will also be used in the thesis of Feifei Hu, the doctoral student working on this project. A summary of the results will be available after completion of the study in about 3 years. We will post the summary of the results on Deakin Universitys CPAN website (http://www.deakin.edu.au/health/cpan/).

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 3 of 8

9.

Participation is Voluntary

Participation in any research project is voluntary. If you do not wish to take part, you are not obliged to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Any information obtained from you to date will not be analysed. Before you make your decision, a member of the research team will be available to answer any questions you have about the research project. You can ask for any information you want. Sign the Consent Form only after you have had a chance to ask your questions and have received satisfactory answers. If you decide to withdraw from this project, please notify a member of the research team or complete and return the Withdrawal of Consent Form attached.

10.

Ethical Guidelines

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies. The ethics aspects of this research project have been approved by the Human Research Ethics Committee of Deakin University.

11.

Complaints

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact: The Manager, Office of Research Integrity, Deakin University, 221 Burwood Highway, Burwood Victoria 3125, Telephone: 9251 7129, research-ethics@deakin.edu.au. Please quote project number 2013-138.

12.

Reimbursement for Your Costs

You will not be paid for your participation in this project.

13.

Further Information, Queries, or Any Problems

If you require further information, wish to withdraw your participation, or if you have any problems concerning this project (for example, any side effects), you can contact Feifei Hu or Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6324 Fax 03 9244 6017 feifeih@deakin.edu.au Manuela Rigo Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6380 Fax 03 9244 6017 m.rigo@deakin.edu.au

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 4 of 8

Page intentionally left blank

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 5 of 8

PLAIN LANGUAGE STATEMENT AND CONSENT FORM

TO: Participants Consent Form Date: Full Project Title: Mobile App to Improve Iron and Zinc Intake, Iron and Zinc Status,
Cognition, Mood and Fatigue in Premenopausal Women

Reference Number: 2013-138

I have read and I understand the attached Plain Language Statement. I freely agree to participate in this project according to the conditions in the Plain Language Statement. I have been given a copy of the Plain Language Statement to keep. I allow the researchers of this project to store my blood samples at Deakin University for future analysis. The researcher has agreed not to reveal my identity and personal details, including where information about this project is published, or presented in any public form. Please tick one of these boxes: I consent to being contacted in the future to be invited to participate in a follow-up study. I do not consent to being contacted in the future.

Participants Name (printed) _________________________________ of _________________________________ (school name) Phone number _____________________ Email ____________________________ Signature ________________________________________ Date ____________
Manuela Rigo Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6380 Fax 03 9244 6017 m.rigo@deakin.edu.au

Feifei Hu Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6324 Fax 03 9244 6017 feifeih@deakin.edu.au

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 6 of 8

Page intentionally left blank

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 7 of 8

PLAIN LANGUAGE STATEMENT AND CONSENT FORM TO: Participants

Withdrawal of Consent Form

(To be used by participants who wish to withdraw from the project)

Date: Full Project Title: Mobile App to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women Reference Number: 2013-138

I hereby wish to WITHDRAW my consent to participate in the above research project and understand that such withdrawal WILL NOT jeopardise my relationship with Deakin University.

Participants Name (printed) _________________________________ of ______________________________ (School name) Signature______________________________ Date _____________________

Please mail or fax this form to: Feifei Hu or Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6324 Fax 03 9244 6017 feifeih@deakin.edu.au Manuela Rigo Deakin University School of Exercise and Nutrition Sciences 221 Burwood Highway, Burwood, 3125 Phone 03 9244 6380 Fax 03 9244 6017 m.rigo@deakin.edu.au

Plain Language Statement & Consent Form to Student Participants Iron study part 1: version 2.0, 30/08/2013

Page 8 of 8