Why have I been invited to participate?
You have been invited to participate in this study because you are the parent or caregiver of a child who has not begun eating solids and plan to start around 6 months of age (as per the Ministry of Health Food and Nutrition Guidelines). You will also be starting before March 2024, as this is when the study will close recruitment.
What is the first food you’re using?
The food that we are interested in using is an oat-milk-based product mixed with either cows or sheep milk, which will be provided to two thirds of participants in the form of a powder. The oat-milk-based product is to be mixed with water to form a paste. This is then either given directly to your baby or can be added to any foods that you give your baby throughout the study. We hope that your baby will be able to work up to consuming 20g of oat-milk-based product each day. Oats, sheep and cows milk are widely accepted foods to be offered to infants as first foods. There are no perceivable risks associated with your baby consuming these foods.
What is the difference between the oat powders?
There are two different oat-milk-based products being used. One is oats mixed with cows milk, and the other is oats mixed with sheep milk.
Safety Message
Both treatment groups involve the use of accepted ingredients in infant nutrition and are manufactured in registered facilities that comply with Food Standards Australia and New Zealand guidelines with respect to manufacturing standards and compliance with food safety requirements, including allergy management. There are no known ingredients that might conceivably cause harm.
Where has the study received ethical approval?
This study has received ethical approval from:
Health and Disability Ethics Committee (Reference: 15547).
What does being a part of this study include?
By being a part of this study, you are agreeing to give your baby the required amount of oat-milk-based product for a total of 4 weeks.
Over the duration of the study, you will be asked to participate in measurements at three time points
- Time point 1: when your baby is around 4½ – 6 months of age (before you introduce any first foods)
- Time point 2: two weeks after you introduce first foods to your baby
- Time point 3: four weeks after you introduce first foods to your baby (upon completion of the study)
Will I get any benefit from participating in this study?
Taking part in this study will help us understand how the introduction of complementary solid foods and changes in milk consumption impacts infant gut bacteria, sleep behaviour and digestive comfort. Your involvement in this study is of great value to the researchers; thank you for considering taking part.
What if I am randomised to be in the control group?
If you are in the control group, you don’t need to remember to feed your child daily amounts of oat-milk based product. Everything else in the study is the same. You will get results of your child’s eating patterns and the effect of this on their microbiome, as well as an analysis of their sleep behaviour and digestive comfort. You will be given a supermarket voucher for the same value as the oat-milk-based product.
Will taking part cost me anything or will I be paid?
Taking part in this study should not cost you anything apart from your time, for which we thank you. The study is conducted remotely, which means there are no clinic visits required; all data collection can be completed from your home; questionnaires are completed online; and couriers transport samples back to the University of Auckland. The oat-milk based product will be supplied to you at no cost for the duration of the study, or you will receive a supermarket voucher for the same value, and all participants will receive a koha (gift) in the form of vouchers as an expression of thanks for dedicating time to this research.
How will my confidentiality be protected?
We treat protection of your personal information as a matter of high priority. Your confidentiality and privacy are guaranteed during your participation in this study. The researchers will de-identify all personal information provided by you, and there is no risk that you will be able to be identified should the results of this study be published. Any identifiable information collected about you, your whānau/family or your baby during this study will remain confidential and will only be revealed with your permission, or except as required by law.
On entering the study, you will be given a unique study identification number, which will be used for identification on all forms, questionnaires and measurements. Any documents, including paper copies of questionnaires, data collection forms or measurements will be stored in a locked filing cabinet in a secure swipe-access area at the University of Auckland, which only the research team has access. The SMILEY study researchers will be trained and monitored by an independent committee, who will ensure the study is carried out according to the guidelines for Good Clinical Practice. An additional independent Data Management Committee will be responsible for the interests and safety of the study participants (mothers and their babies).
What will happen with my baby’s stool samples?
Your baby’s stool samples will be analysed to assess how the oat-milk-based product intervention has affected their gut microbiota (the types of gut bacteria present), measuring bacterial diversity and production of short-chain fatty acids.
Samples will be analysed at AgResearch (Palmerston North). All samples will be labelled with your SMILEY ID number, not your name, and will be stored in secure freezers in an access-restricted area at the AgResearch Palmerston North. Your samples will be kept until 2026 after data and sample collection have been completed to allow for any re-testing that may be required.
What if I no longer wish to participate in this study?
Taking part in this study is your choice and is completely voluntary. You are free to withdraw your child at any time without having to explain why. Withdrawing from the study will not influence any future involvement you might have with the University of Auckland. Should you withdraw from the study, any information that has been previously collected will be retained to ensure that the results of the research project can be measured properly, unless you specifically ask for these to be removed.
What happens with the results?
If you give us your permission by signing the Consent Form, findings from the study will be used in internal reports, conference presentations, and research publications. Participating whānau/family will be provided with a report detailing the main study findings and any implications this may have for you.
The results will be stored using a coded number on a computer at the University of Auckland. Any data collected in paper form will be stored in a locked room. After completion of the study, we will keep your data for 10 years after the youngest participant has turned 16 years of age. You will only be contacted in the unlikely event that we would like to perform further unspecified analysis. If we cannot contact you at this time, we will not perform this analysis on your samples.
What should I do if I want to discuss the study further before I decide?
When you have read this information, a member of the study team will discuss it with you and answer any questions that you may have. You may wish to talk about this study with other people, such as family/whānau, friends, or healthcare providers. If you would like to know more at any stage, please do not hesitate to contact the trial managers (Sophia Amjad and Philippa Miskelly) directly at thesmileystudy@auckland.ac.nz.