Taking part in this study involves being randomised into one of three groups; one group will receive a cow milk-based product, one group will receive a sheep milk-based product and another group will act as a control and not receive any product.
There are three data collection points, which are conducted remotely over the study period of 4 weeks.
The first data collection point is just before your baby starts solids, the second is 2 weeks after starting solids, and the third is 4 weeks after starting solids.
We will also call you for a quick check-in while you’re in the study with us.
Baseline Data Collection
This data collection occurs before you decide to introduce first foods to your baby.
Information collected from your baby:
- Length
- Weight
- Stool (poo) sample
- Health Questionnaire
- Sleep Questionnaire
Information collected from mother:
- Health Questionnaire
- Sleep Questionnaire
Week 2 Data Collection
Information collected from your baby:
- Stool sample
- 3-day record of dietary intake
- Sleep and wake data
- Sleep Questionnaire
- Health record
- Intervention adherence
Information collected from mother:
- Health Questionnaire
- Sleep Questionnaire
Week 4 Data Collection
Information collected from your baby:
- Length
- Weight
- Stool sample
- 3-day record of dietary intake
- Sleep and wake data
- Sleep Questionnaire
- Health record
- Intervention adherence
Information collected from mother:
- Health Questionnaire
- Sleep Questionnaire
Descriptions of what we hope to collect from your baby:
Length and weight
Data collected from Well Child book.
Stool (poo)
You will be provided with a study collection kit with instructions for the successful collection, storage at home, and transport of the sample back to the University of Auckland. Stool collection is not an invasive or upsetting procedure for your infant and a small quantity can be collected from the nappy. Samples will be used to measure the microbiome and fatty acids and will take 5 minutes to collect at home.
Dietary intake
Infant food intake will be collected using parent-completed, 3-day food records. The 3-day food record will be collected twice (halfway and completion visits) and will take approximately 20 minutes each time.
Sleep and wake data
Infant sleep/wake data will be recorded using a parent-completed sleep diary. The sleep diary will be collected twice (halfway and completion visits) and will cover a 24-hour period each time.
Information on illnesses and healthcare visits
Throughout the study, we ask you to log any time your baby is unwell or has a visit to their GP, hospital or health centre using the paper record booklet we will provide you with.
Information on intervention adherence
If you are randomised to one of the intervention groups (sheep-milk-oat based product or cow-milk-oat based product), we will ask you to log how much of the product your baby consumes each day using the paper record booklet we will provide you with.
Descriptions of what we hope to collect from you (mother):
Sleep Questionnaires
Parent sleep quality, impairment, and disturbance will be measured using brief validated questionnaires. These measurements will take 15 minutes to complete via online questionnaires.
Health Questionnaires
We will gather information on your family, household, participating baby’s health and feeding, and progress throughout the study. These questions will be completed via online questionnaires and will take approximately 30-45 minutes to complete.