The WOMBI Study - Participant Information sheet

Does the exclusion of iodine fortified bread in the diet of mid-life women result in low iodine status?

Download here: WOMBI Participant Information Sheet.pdf (309 KB)

Information for Participants

You are invited to take part in a post graduate research study investigating the effect of avoiding iodine fortified bread products on iodine status of mid-life women living in the northern suburbs of Auckland.

We are looking for 50 mid-life women to participate in this study.
To be eligible for our study you should:
•    Be female, between 40 and 65 years of age.
•    Live in the northern suburbs of Auckland
•    Have no have thyroid, kidney, or heart disease.  
•    Not be taking thyroid medication, supplements containing more than 10 mcg of iodine, lithium medication, or hormone replacement therapy
•    Not smoke more than 5 cigarettes per day
•    Not consume more than one slice of bread daily

Following your expression of interest for this study, you will be contacted by the Research team from Massey University to assess your eligibility. Once accepted into the study you will be required to visit the Human Nutrition Research Unit at Massey University on one occasion. At this visit you will be asked to provide personal and medical details. Your height, weight and percentage of body fat will be measured and you will be asked to provide a 16ml blood sample (approximately one tablespoon of blood).  A container and instructions for collecting a 24hour urine sample will be given to take home and complete. Lastly you will be asked to complete a food frequency questionnaire and a 3-day food diary.

About the Study

We will make an appointment for you to visit Massey University, Albany campus.

Involvement in this study will include:

A visit to the research unit:
You will be requested to complete a food frequency questionnaire and provide your date of birth. The questionnaire may be completed while you are at the research unit. You will spend approximately one hour with the researcher who will also measure your height, weight and body fat percentage. All measurements will be made in a private area by female researchers over light clothing so you do not need to get undressed.

At this visit you will also be provided with containers to take home to collect a sample of urine collected over 24 hours.  You are requested to collect all your urine over a consecutive 24-hour period and keep it in the cool bags provided until collected by the one of the research team.  The urine will be subsequently analysed for iodine concentration.

Also, you will be asked to complete a 3-day food diary which can be taken home and returned using the stamped, addressed envelope provided and sent to the Nutrition Research Unit at Massey University.
Lastly you will be asked to provide a blood sample of 16ml. The blood sample will be analysed for thyroglobulin, thyroglobulin antibodies and thyroid hormones (TSH, fT3, fT4).

Risks and Benefits

There will be no charges for any of the tests that you undertake. The main benefit of taking part in this study is that you contribute to a greater understanding if avoiding bread that is fortified with iodine results in a lower iodine status.  New Zealand (NZ) has low soil levels of iodine which adversely affects the amount of iodine in the food that is grown and produced here. As a result, the NZ people are vulnerable to iodine deficiency.  To improve the iodine status of the population in 2009 the NZ government introduced the mandatory fortification of all non-organic and commercially produced bread with iodised salt.  However, as some people choose not to eat bread or choose to eat only organic bread the contribution to dietary iodine intake from bread sources is limited.
You will also receive information about your dietary intake and body composition.
There are no personal risks to your health, but the blood tests could potentially identify thyroglobulin, thyroglobulin antibody and/or thyroid hormone levels outside the normal range. If we identify any possible abnormalities, we will advise you to consult your General Practitioner for further investigation.

Participation

You are under no obligation to accept this invitation to take part in this study. If you do decide to participate, you have the right to:
•    Decline to answer any question;
•    Withdraw from this study (at any time without having to give a reason);
•    Ask any questions about this study at any time during participation;
•    Provide information on the understanding that your name will not be used unless you give permission to the researcher;
•    Be given access to a summary of the project findings when it is concluded.

General

If you want to discuss any aspect of this study you should contact the Principal investigator, Jacqui Finlayson (027 2927152; email; jacqui.finlayson.1@uni.massey.ac.nz)

If you have any queries or concerns regarding your rights as a participant in this study you may wish to contact the Health and Disability Advocacy; telephone 0800 555 050.

At the conclusion of the study we will provide a report of the outcome to those involved in this study and we will send the results by mail.

Confidentiality

No material which could personally identify you would be used in any reports on this study. Information collected from you in this study will be stored securely in the Department of Nutrition and will only be available to study personnel. When this study is completed, all material will be destroyed.

Compensation for Injury

If physical injury results from your participation in this study, you should visit a treatment provider to make a claim to ACC as soon as possible. ACC cover and entitlements are not automatic and your claim will be assessed by ACC in accordance with the Accident Compensation Act 2001. If your claim is accepted, ACC must inform you of your entitlements, and must help you access those entitlements. Entitlements may include, but not be limited to, treatment costs, travel costs for rehabilitation, loss of earnings, and/or lump sum for permanent impairment. Compensation for mental trauma may also be included, but only if this is incurred as a result of physical injury.

If your ACC claim is not accepted, you should immediately contact the researcher. The researcher will initiate processes to ensure you receive compensation equivalent to that to which you would have been entitled had ACC accepted your claim.

Please feel free to contact the researcher if you have any questions about this study.

This project has been reviewed and approved by Massey University Human Ethics Committee: Southern A, application no 16/52. If you have any concerns about the conduct of this research, please contact Mr Jeremy Hubbard, Chair, Massey University Human Ethics committee: Southern A, telephone 04 801 5799 x 63487, email humanethicssoutha@massey.ac.nz.

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