| Participant Information and Informed Consent Form: Index Participants You are invited to take part in a study of healthy New Zealand (NZ) foods to see whether eating these foods helps people to be healthier. As part of this study, we are providing your household with more than half of the food that you will eat each week for 12 weeks (the rest of the food you will shop for or provide as usual). We will follow up with you again at several times after the 12 weeks and in total the study will take about one year. Whether or not you take part in this study is your choice. If you don’t want to take part, you don’t have to give a reason, and it won’t affect any healthcare you receive. If you do want to take part now, but change your mind later, you can pull out of the study at any time. This Participant Information Sheet will help you decide if you’d like to take part. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to you might be, and what would happen after the study ends. We will go through this information with you and answer any questions you may have. You do not have to decide today whether you will participate in this study. Before you decide, you may want to talk about the study with other people, such as family, whānau, friends, or healthcare providers. Feel free to do this. To take part in this study, at least one (1) other member of your whānau/household MUST take part in the study with you. Any adult who lives in the same house as you who wants to take part will sign a consent form too. They will do the same study visits and questionnaires as you, and be invited to do the same measurements. Any children over the age of 5 years and teens who are in your household who would like to participate are welcome to. There is a separate information sheet that they can read. They will also be asked to complete questionnaires and invited to have measurements of weight, height, waist and blood pressure; teens (11 to 16 years) can choose whether or not to have the blood tests but children 10 years and younger will NOT have blood tests. If you agree to take part in this study, you will be asked to sign the Consent Form. You will be given a copy of both the Participant Information Sheet and the Consent Form to keep. This document is 12 pages long. Please make sure you have read and understood all of the pages. You will also be asked to take part in a sub-study (a separate but related study) so that we can get more information about your experiences in this study and the foods we are sending out and how your household uses them. There is a separate information sheet for you to read and consent form if you choose to take part in the sub-study. WHAT IS THE PURPOSE OF THIS STUDY? The New Zealand diet that we wish to test in this study is one that is nutritious and healthful. We want to give whānau (families) healthy foods and recipes to see if this makes it easy for people to use these foods. We also want to see what difference, if any, providing dietary education makes to being able to maintain change in your diet. And we want to see what happens if people eat the foods we have picked - whether it helps their blood glucose, blood pressure, weight and blood cholesterol. It is not just the person in the study we want to hear from, but how their whole household/whānau finds the foods and whether it makes a difference to their health. WHAT WILL MY PARTICIPATION IN THE STUDY INVOLVE? You have been invited to take part in this study because you have some risk factors that might lead to diabetes in the future. You will be asked to sign a consent form to say you are happy to take part in the study. To be in the study, you must agree to all of the components of the consent form, except the saying of a karakia which is optional, and the sub-studies which you can choose to do or not. We will make it very clear which parts are compulsory, and which are the optional parts. Please check with us if you are not certain. You and your household will receive more than half of the food that you will eat each week for 12 weeks, however you will be involved in this study for up to 16 months. The food during this 12-week period will be delivered to you or collected by you from a convenient location. The researchers will select the foods for you and will arrange delivery of these foods. Before taking part in the study, we will check the medications you take, and the health conditions you have to make sure it is OK for you to be in the study. This will be via telephone or email. We may also need to contact your GP to get more information about your medical history. The study will involve coming in to Auckland/Wellington/Lower Hutt/Christchurch. If you do decide that you wish to take part, you must be able and willing to attend all the site visits and also be willing to adhere to local health and safety regulations. You will be randomised (by chance like the flip of a coin) to one of two groups (Group A or B). Group A will attend 6 visits (over 64 weeks) and Group B will attend 5 visits (over 52 weeks). The first two visits for both groups will involve talking through this information sheet and undergoing tests to see if you qualify to take part in the study. You and the other members of your household/whānau who want to take part in the study can all come together as a group to the second visit. After the second visit Group A will continue with their usual diet and lifestyle for 3 months, then they will receive the food and dietary education for the next 3 months. After this the food deliveries will stop and you will be randomised again. For the next 3 months half of group A will continue to receive ongoing dietary education and support while the other half will not. Group B will receive the food deliveries and dietary education for the first 3 months. After this the food deliveries will stop and you will be randomised again. For the next 3 months half of group B will continue to receive ongoing dietary education and support while the other half will not. Both groups will have a final 6 months of follow up with no food or dietary education support. Visit 1 (both groups): You will come to this visit fasting (nothing to eat or drink except water for the previous 8 hours). At this first visit you will have time to ask questions and decide if you want to go ahead with the study before you sign the consent form. This visit is to see if you are eligible for the study, so you may or may not be accepted on to the study after this visit. You will have a fasting blood test taken and we may not be able to tell you if you are accepted on the day as we need to wait for blood test results to come back. At this visit, we will ask you questions about your medical history and any medications you are taking, and you will have your height, weight, waist and blood pressure measured. You will have a blood test to check your glucose (sugar) and cholesterol levels. We will also check to see whether you have diabetes that you might not know about with a blood test called HbA1c. This visit will take about one hour. We will also talk with you about who is in your household/whānau that would like to take part. Once we get the blood test results back, we will call you or let you know during the visit to let you know the result and make a time for Visit 2 if you have been accepted into the study. There is a chance your blood results mean that you cannot be accepted into the study, if this is the case the contact person will explain why. Visit 2 will be 1-3 weeks after your first visit. If you are accepted, we will give or send you a faecal (poo) sample kit to collect a sample and bring with you to visit 2. We will provide you with instructions on how to collect the sample at home and we only need a tiny sample. This can be kept at room temperature until the visit. Visit 2 (both groups, 1-3 weeks after Visit 1): At the second visit, you will bring with you the members of your household/whānau who would like to take part in the study. If your household/whānau members think they will have the blood test taken they will attend the visit fasting (nothing to eat or drink except water for at least 8 hours). They will have time to ask questions and decide if they want to join the study before they sign a consent form (or one of the assent forms if they are under 16 years old). At this visit you will bring back your faecal (poo) sample and have the following tests: · Blood pressure · Weight and waist circumference · Urine and blood test · A DXA scan and/or bioimpedance measure to measure body composition (how much of your body is muscle or fat) · A blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. · A meal test You and your household/whānau members will all be asked some questions about what you usually eat, the exercise you usually do and your quality of life. The food questionnaire asks about all the things you have eaten and had to drink on one day and how often you eat certain foods. This takes about 20 minutes. The exercise questionnaire asks what sort of activity you do in a usual week and takes about 5 minutes. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. If you complete this questionnaire, it will be reviewed by the researcher at your visit. The findings from the questionnaire will be shared with you and you will be able to discuss any aspects with the researcher. If you feel you need support in any way based on the findings of this questionnaire, the researcher will refer you to a service or health professional if you so wish. If your household/whānau members choose, they will have their height, weight, waist and blood pressure measured, we will ask them questions about their medical history and any medications they are taking, as well as take a blood test to check their glucose (sugar), cholesterol levels and an HbA1c. This visit will take about 2 hours, depending on your research site. At this point it will be randomly (by chance) decided if you will wait 3 months to start getting the food (group A) or start getting the food straight away (group B). Group A, Visit 3: At this visit, you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for at least 8 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will have a DXA scan and return your faecal sample. If you had a meal test at visit one you will repeat this here. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. After visit 3 for Group A, the study foods will then be delivered to your home each week. We will be providing about 50-75% (half to three quarters) of the food your household/whānau needs for each week. This will include food for five main meals and extra fruit, snacks, and breakfast foods. The food delivery will include recipes for you to use if you wish. You don’t have to be a good cook to be part of this study, just willing to give it a go. We will check in with you after a week to make sure everything is going okay. Phone call after 2 weeks: After you have been eating the food for two weeks, we will check in with you to make sure that you are not having any problems with the food delivery. Email after 6 weeks: After you have been eating the food for six weeks, we will check in with you to ask if you have had any new health problems or started any new medications. We will send you a link every 2 weeks to complete some questions about what you have been eating. At this visit you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for at least 8 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will return your faecal sample. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. Visit 5: At this visit you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for 12 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will return your faecal sample. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. Group B: After visit 2, the study foods will be delivered to your home each week. We will be providing about 50-75% (half to three quarters) of the food your household/whānau needs for each week. This will include food for five main meals and extra fruit, snacks, and breakfast foods. The food delivery will include recipes for you to use if you wish. You don’t have to be a good cook to be part of this study, just willing to give it a go. We will check in with you after a week to make sure everything is going okay. Phone call after 2 weeks: After you have been eating the food for two weeks, we will check in with you to make sure that you are not having any problems with the food delivery Email after 6 weeks: After you have been eating the food for six weeks, we will check in with you to ask if you have had any new health problems or started any new medications. We will send you a link every 4 weeks to complete some questions about what you have been eating. Visit 3: At this visit you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for at least 8 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will have a DXA scan and return your faecal sample. If you had a meal test at visit one you will repeat this here. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. Visit 4: At this visit you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for at least 8 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will return your faecal sample. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. Visit 5: At this visit, you and your household/whānau who are having the blood test will attend the visit fasting (nothing to eat or drink except water for 12 hours). You will be asked some questions about what you have been eating and the exercise you usually do and your quality of life. If you identify as Māori, you will be asked some questions about Kaupapa Māori wellbeing. You, and your household/whānau members who choose to do so, will have your weight, waist and blood pressure measured. You will return your faecal sample. We will ask you questions about any new health problems you have experienced and any medications you are taking, as well as take a blood test to check your glucose (sugar), cholesterol levels, HbA1c and a blood sample to store in our freezer as we may need this to test some other markers of risk for diabetes or heart disease. This visit will take about one and a half hours. If your whānau were to separate over the course of the study, the researcher would attempt to gather data from those living with you until the end of the study. Study Investigations Explained: DXA Scan: is an X-ray scanning method, to measure quantity of bone, fat and muscle in the body. The scan takes about 10 minutes. You lie quietly on an open bed and a scanning arm passes quickly over the top of your body. You have to lie quietly without moving, but it is not an unpleasant experience and you do not feel anything. As the scanning arm passes over you it emits 2 types of very low dose x-ray, similar to the radiation dose that you would receive if you took a short flight – perhaps between Auckland and Wellington. The DXA then measures the density of the different tissues in your body. Bone is very dense so it appears bright white on the scan. Muscle is less dense and so it is less white, and fat even less dense and so it is the least white of all. All participants of child-bearing potential must return a negative pregnancy test before their DXA scan. Faecal (poo) sample: sometime in the 3 days before the study visit we ask you to collect a faecal sample at home. We will provide you with the kit and instructions on how to do this and we only need a tiny sample. This can be kept at room temperature until the visit. Meal test: You will be provided with a standard meal to eat and drink. We will take blood samples from the cannula in your arm before and every 15-30 minutes for 2 hours following this meal. For the whole day, the total volume of blood taken will be 200 ml, this is less than 1 cup and, less than half the volume of a blood donation. Before, during, and after the meal, test participants will be asked to rate how hungry and full they feel WHAT ARE THE POSSIBLE BENEFITS AND RISKS OF THIS STUDY? We cannot guarantee or promise that you will receive any benefits from this study. However, we hope that eating these foods will help to improve your health or improve feelings of wellbeing. This might be from lower blood sugars, cholesterol or blood pressure. We are providing 50 to 75% of your household/whānau food for 12 weeks. We hope that this will also help you in preparing and eating food together. There are small risks related to the blood tests required for this study, e.g., bruising, fainting or light-headedness. Also, when people change their diets to include more fibre, they might have some extra flatulence (farting / patero) or loose bowel motions. This should settle down when your body gets used to the new foods. The radiation from the DXA is very low and isn’t a problem on its own, but if you are regularly exposed to radiation elsewhere you may want to talk to us or your GP about this. Although we have very careful processes to protect your data, no system is completely failsafe. Therefore, there is a very small risk of breach of privacy. When taking part in a study that involves you changing your diet, there is a chance that if you aren’t able to do that, that you may feel like you haven’t been successful if you do not stick to the meals. We don’t want you to feel that, and all we ask is that you do your best. We will be very interested in any reasons why you may not have been able to this so we can help others. WHO PAYS FOR THE STUDY? This study is funded by the New Zealand Government through their High Value Nutrition National Science Challenge programme. There will be no cost to you for taking part in the study and there is no payment for taking part; however, we will give you $30-35.00 in MTA vouchers or equivalent for the household/whānau for each of the 5 visits, towards your travel costs. The food we will send you is also free. WHAT WILL HAPPEN TO MY BLOOD AND FAECAL (POO) SAMPLES? The blood samples taken at Visit 1 will be analysed the day they are taken at the for glucose (sugar), cholesterol and a test for diabetes (HbA1c). Other samples will be stored until the end of the study to test for some other markers of risk for diabetes or heart disease and will be analysed together. At the end of the study any remaining samples will be destroyed according to local guidelines. Your name will NOT be on the sample tubes, only a study ID number. For this study, blood samples will be tested in New Zealand, and/or overseas . If you want to withdraw from (leave) the study you can tell us what we should do with your blood samples. You might let us test the samples we already have but not take any new ones, or you can ask for them to be destroyed or returned to you. The faecal (poo) sample will be stored for later analysis of the microbiome (bacteria in the bowel) as this relates to diet and health. The faecal samples cannot be returned to you. If you give us permission, we would like to take an extra sample of blood to store for a possible future study. We will ask you this separately and you would sign a separate consent form. This sample would be stored in a registered bio-bank. This way if there are new discoveries in the future we can test stored blood rather than have to run a whole new study. Genetics If you give us permission, we would like to analyse your blood sample to look at your genetics. Studying genes involves looking at the DNA which is the genetic code that is found inside the body’s cells. We are investigating how differences in DNA may affect how the body responds to kai (food), and how this might determine the risk of developing metabolic diseases like gout, diabetes, heart disease and obesity. DNA is prepared from a sample of your blood. If you would like, we can arrange for a karakia when your left-over blood or DNA is disposed of. Please indicate this in the consent form. When DNA is made, it is a clear liquid in a test-tube. Your genetic code is inside the DNA. In the past we have used labour intensive laboratory methods to look at certain genes in the liquid DNA. However, by using the latest technology we can now ‘decode’ the DNA in the liquid into a ‘sequence’ which is stored on a computer. We can then more easily look at the genes we are interested in, and we can also uncover versions of genes that are specific to you and your family. Your genetic information is protected on sequence computers. We would look for and study only the genes which are related to how you use and store kai (food), and related metabolic diseases It is important to know that there is no one gene that determines your health or metabolism, but a number of small changes which contribute to your body’s response to a meal. We will NOT be testing other genetic diseases that you could be carrying. You will NOT receive any results relating to your specific genetics. We acknowledge that for Māori there may be cultural factors around giving blood. Please talk to us about this as we can help find a way to make this a good experience. We have a karakia and staff who are comfortable in saying this, but you might wish to say a karakia yourself or have someone else do this. WHAT IF SOMETHING GOES WRONG? If you were injured in this study, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted.You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover. WHAT WILL HAPPEN TO MY INFORMATION? During this study, the researchers will record information about you and your study participation. This includes the results of any study assessments. If needed, information from your hospital records and your GP may also be collected. You cannot take part in this study if you do not consent to the collection of this information. Identifiable Information Identifiable information is any data that could identify you (e.g. your name, date of birth, or address). Only study researchers will have access to your identifiable information. Although it is very unlikely, your data may need to be disclosed to The Health and Disability Ethics Committee, for legal and regulatory purposes, or to your GP or other medical teams if it is directly relevant to your health and wellbeing. If you disclose information during the study that leads the researchers to suspect severe distress, depression, anxiety or suicidal thoughts then we will contact your GP. We will tell you that we have done this. Some information (name, address, email and phone number) needs to be given to the companies who will to deliver your meals to your home. They will not use this information in any other way and they will not send you any advertising after the study is finished. Your information will be deleted from their system when you stop getting the meals delivered. De-identified (coded) Information To make sure your personal information is kept confidential, information that identifies you will not be included in any report. Instead, you will be identified by a code. The researchers will keep a list linking your code with your name, so that you can be identified by your coded data if needed. The following groups may have access to your coded information: · The High Value Nutrition researchers for the purposes of running this study. · People associated with the High Value Nutrition group if audited. The results of the study may be published or presented, but NOT in a way that would identify you individually. Security and storage of your information Your identifiable information is held at Auckland/Wellington/Lower Hutt/Christchurch during the study. After the study it is transferred to a secure archiving site and stored for at least 15 years, then destroyed. Your coded information will be entered into an electronic database. Coded study information will be kept in secure, cloud-based storage indefinitely. All storage will comply with local and/or international data security guidelines. Risks Although efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed. Even with coded and de-identified information, there is no guarantee that you cannot be identified. The risk of people accessing and misusing your information (e.g. making it harder for you to get or keep a job or health insurance) is currently very small, but may increase in the future as people find new ways of tracing information. Rights to access your information You have the right to request access to your information held by the research team. You also have the right to request that any information you disagree with is corrected. Please ask if you would like to access the results of your screening and safety tests during the study. If you have any questions about the collection and use of information about you, you should ask one of the study team in Auckland/Wellington/Lower Hutt/Christchurch. Rights to withdraw your information You may withdraw your consent for the collection of your information at any time, by informing your Study coordinator. If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you. However, information collected up until your withdrawal from the study will continue to be used and included in the study. CAN I FIND OUT THE RESULTS OF THE STUDY? Everyone who takes part will be sent a summary of the results at the end of the study. If you would like your specific test results, you will be able to request this at the time. WHO HAS APPROVED THE STUDY? This study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. WHAT HAPPENS AFTER THE STUDY OR IF I CHANGE MY MIND? Study data will be retained for at least 15 years in a secure storage unit, and then destroyed. Should you change your mind at any point you can withdraw from the study without experiencing any disadvantage. WHO DO I CONTACT FOR MORE INFORMATION OR IF I HAVE CONCERNS? If you have any questions, concerns or complaints about the study at any stage, you can contact: The Wellington diabetes research team at diabetesresearch@ccdhb.org.nz For Māori health support please contact: Whānau care services Cultural Care Centre, Level 2, Wellington Regional Hospital 04 806 0948 If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on: - Phone: 0800 555 050
- Fax: 0800 2 SUPPORT (0800 2787 7678)
- Email: advocacy@advocacy.org.nz
You can also contact the health and disability ethics committee (HDEC) that approved this study on: - Phone: 0800 4 ETHICS
- Email: hdecs@health.govt.nz
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