Taking part in this study involves three in-person visits with your baby to our clinical research centre in Grafton. Visits occur over a four month period with the first visit being before your baby starts solids. We will also call you for a quick check-in each month you’re in the study with us. The following information and samples are collected at each clinic visit:
Clinic visit 1
Age around 6 months
This visit occurs before you decide to introduce first foods to your baby
Information collected from your baby:
- Length
- Weight
- 3 – 5 mL blood (optional)
- 2 stool samples
- Sleep and wake data
Information collected from mother:
- Health questionnaire
- Stool sample (optional)
- 12 ml breast milk (optional)
- Diet questionnaire
- Sleep questionnaire
Clinic visit 2
Age 8 months
Information collected from your baby:
- Length
- Weight
- 2 stool samples
- 3-day record of dietary intake
- Sleep and wake data
Mother
- Stool sample (optional)
- 12 ml breast milk (optional)
- Diet questionnaire
- Sleep questionnaire
Clinic visit 3
Age 10 months
Information collected from your baby:
- Length
- Weight
- 3 – 5 mL blood (optional)
- 2 stool samples
- Intervention adherence
- 3-day record of dietary intake
- Sleep and wake data
Information collected from mother:
- Stool sample (optional)
- 12 ml breast milk (optional)
- Diet questionnaire
- Sleep questionnaire
Descriptions of what we hope to collect from your baby:
Length and weight
Using standard methods and equipment e.g. measuring mat (length) and infant scales (weight). This measurement will take approximately 3-5 minutes.
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 to clinic. 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 an actigraph (a method of recording infant sleep through movement, via a small sensor device – like a Fitbit, fitted on your baby’s leg) for 5 days, and a sleep diary. This measurement requires 5 days of sleep/wake data (including sleep diary). Collection will commence upon leaving the clinic appointment and all data can be captured using the SUN app.
Information on illnesses and healthcare visits
As our primary outcome of interest is immunity, 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. You can log these occurrences in our study app or paper record booklet. At the end of the study, we ask your consent for us to contact your baby’s GP to confirm the health and illness information we have collected from you.
Information on intervention adherence
If you are randomised to one of the intervention groups (kūmara powder or kūmara powder with added resistant starch) we will ask you to log how much of the kūmara powder your baby consumes each day. This can be recorded in our paper record booklet or through our study app.
Blood sample
We ask for two blood samples from your baby. These are optional and occur at the first and last clinic visit. Samples will be obtained using methods that minimise distress, including the use of trained paediatric phlebotomists, and play therapy. Breastfeeding is the most effective soother. Approximately 3 – 5 ml (up to 1 teaspoon) of blood needs to be collected. All samples will be collected by an experienced person and analysed to measure immune markers. This measurement will take approximately 5 minutes.
Descriptions of what we hope to collect from you:
Weight and height
These will be measured once, at the first appointment. It is useful to correlate with infant growth.
Stool sample
You will be provided with a study collection kit for adult samples and instructions for the successful collection, storage at home, and transport of the sample to clinic. Sample collection should take approximately 5 minutes at home. This sample will help us understand the relationship between your infant’s microbiome (gut bacteria) and your own.
Breast milk sample
A breast milk sample from mothers who are currently breast feeding will be collected using a study collection kit, with instructions for the successful collection and storage of the sample. Approximately 12 mL of expressed breastmilk will be collected with documentation of the date and time of collection. Collection can be done either at the clinic visit or at home via hand expressing or using a pump. Sample collection time will vary, depending on supply and breast milk flow. Breast milk samples will be used to measure nutritional composition, microbiome and immune properties.
Dietary intake
Maternal food intake will be collected using a validated food frequency questionnaire. This measurement will take approximately 20 minutes during the clinic visit.
Sleep questionnaires
Parent sleep quality, impairment, and disturbance will be measured using brief validated questionnaires. This measurement will take 15 minutes to complete via an online questionnaire.
Questionnaires
We will gather information on your family, household, participating baby’s health and feeding, and monthly progress throughout the study. These questions will be completed via online questionnaires and will take approximately 30-45 minutes to complete.
Additional opportunities for data collection
Aside from the measurements described above, we will be asking you to give consent to be able to contact your General Practitioner (GP) to obtain access to medical records to confirm reasons for:
- Infection-related GP visits, medications, and hospitalisations from 6 to 12 months of age;
- Immunisation records via “The National Immunisation Registry”
This information will only be used to confirm the details you have provided in the questionnaires and record booklets, and will not be shared with any other parties outside those involved in the study.
If you think your baby will be attending day care during your designated food record period (at timepoints 2 and 3), we will be asking you to give consent to be able to contact their day care to obtain an accurate record of food intake when your baby is not in your care.