FAQs

Who can take part in the EAT Study?
Recruitment is now complete and no further participants are required.
Participation in the EAT Study was open to mothers who fulfilled the following criteria:
1. I am pregnant or my baby is under three months of age
2. My baby will be or is being exclusively breastfed for at least 3 months. Exclusive means that your baby has no other milk (e.g. cow’s milk formula) or solid foods before this stage.
3. We are willing to attend three clinic visits in London over a three year period.

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Who is UNABLE to take part in the EAT study?
There are several reasons which prevented people being eligible to participate in the EAT Study:

• Mothers not planning on exclusively breastfeeding for at least 3 months
• Mothers having twins (or other multiple births)
• Families planning on excluding one or more of the six intervention foods from the home
• Families planning on emigrating in the next 3 years

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What about breastfeeding?
Breastfeeding is best for babies. In the EAT Study the aim is for all mothers who are taking part, to breastfeed their infants for at least the first six months.

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Will introducing solids early affect my breastfeeding?
In the EAT study, the decision has been taken to give the cow’s milk protein exposure as yoghurt rather than cow’s milk based formula. The reason for this is that introducing formula milk can affect the pattern and duration of breastfeeding. A recent large Swedish study (Hörnell et al, 2001) showed that the introduction of solids was associated with no or minor changes in breastfeeding frequency and suckling duration. Breastfeeding frequency remained constant the first month after the introduction and then declined slowly, while daily suckling duration started to decline slowly when solids were introduced. Breastfeeding duration was not associated with infants’ age at introduction of solids. However, in infants given formula, as soon as regular formula feeds started, the breastfeeding frequency and suckling duration declined swiftly.
Therefore all mothers in the EAT Study will be encouraged to breastfeed for at least 6 months and to avoid formula milk during this period.

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What are the parental responsibilities of taking part?
The greatest responsibility for parents/guardians is to help ensure that their child carries out the requirements of the study. For the Early Introduction Group, this means consuming the six foods in the required quantity throughout the duration of the study and aiming to continue breastfeeding for at least six months. For the Standard Introduction Group this means avoiding introducing any allergenic foods before six months of age and aiming to try and exclusively breastfeed until around six months of age.

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How will parents/guardians know what to expect in the study?
Recruitment to the study is now complete. A one page summary sheet is downloadable from this site which summarizes what the study is about and what is involved for participants. The full information leaflet/consent form is also available for download, which details all aspects of the study, including the duration of the study and visit schedules where their child’s health will be monitored. Any questions can be discussed with the Study Team who can be contacted by telephone (0800 358 0021).

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Is it difficult to follow the dietary recommendations?
Mothers in the Early Introduction Group will be given a personalised diary by one of the study dieticians giving a timetable of which foods are to be introduced and in what order. They will be able to help with practical advice and information to assist in introducing these foods into the child’s diet. EAT Study dieticians will also be available to answer specific questions or provide advice as needed by participants. The weekly amount of each food that should be eaten by infants in the Early Introduction Group is: 3 teaspoons of peanut butter, 3 teaspoons of tahini (sesame paste), 2 small cow’s milk based yoghurts, one small egg, two wheat based biscuits (e.g. Weetabix) and the amount of fish within two fish fingers. Once all six foods have been successfully introduced parents will be provided with recipes to combine several of the foods together making it easy to follow the recommendations.

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What happens if my child is already allergic to one of the six intervention foods?
Children enrolled in the EAT study in the Early Introduction Group will be screened for evidence of pre-existing food allergies to the six intervention foods. Any infant with a result suggesting a possible allergy to one of the foods will be given their first planned exposure to the food under the medical supervision of EAT Study specialists at Evelina Children’s Hospital at St Thomas’ Hospital. In this environment, any resulting allergic reaction can be diagnosed quickly and appropriate medical treatments to reverse the reaction may begin without delay. If an allergy to one of the six foods is confirmed this food will be excluded from the diet and the family will be provided with advice about avoiding this food and appropriate management of accidental exposures. The infant will still be encouraged to eat the other intervention foods.

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How will you find out if my child develops a food allergy?
During the course of the study, we will contact you on a regular basis to ask if your child has had any symptoms suggestive of a food allergy. You will also be able to contact us by telephone if you think your child may have had a reaction to a food. If the symptoms are suggestive of food allergy we will arrange for your child to be assessed at the Evelina Children’s’ Hospital. EAT Study paediatric allergy specialists will provide individual counselling on treating and dealing with childhood allergies and will continue to monitor your child’s progress for the duration of the study. Referrals will be made outside the study as appropriate.

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Are there any other risks to participating in the study?
While every precaution has been and will be taken to ensure the safety of all procedures and recommendations involved in the EAT Study, volunteering for a clinical research study generally carries some risk to its participants, both known and unknown. EAT Study staff will explain the potential risks to you in detail and answer any questions you might have before you decide to participate.

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Will it cost me anything to participate?
Other than time, the only expense incurred is the purchase of the intervention foods for those infants in the Early Introduction Group. The six intervention foods are readily available from shops and supermarkets. Dietetic counselling will be provided as part of the study. We are able to reimburse travel costs incurred whilst attending study visits.

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How much time will it take to complete the questionnaires in the study?
We will ask participating mothers to complete a series of questionnaires about themselves and their baby’s diet and health. The following table summarises these and gives an indication of how long we anticipate they will take to complete and whether they will be completed at home or elsewhere. We will use email to inform participants about appointment times for the assessment visits and for general communication with participants.

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Assessment point	Subject	Duration
20 weeks of pregnancy (if recruited during pregnancy)	Maternal diet and health	30 minutes
34 weeks of pregnancy (if recruited during pregnancy)	Maternal diet and health	20 minutes
Post delivery
3 months	Infant health	20 minutes
3 months	Maternal diet in pregnancy (if recruited after birth) and whilst breastfeeding
4-12 months - monthly	Infant health and diet	20 minutes
6 months	5 day infant food diary	1 hour
One year assessment	5 day infant food diary	1 hour
One year assessment	Infant health and diet	20 minutes
15-35 months - 3 monthly	Infant health and diet	20 minutes
Three year assessment	Infant health and diet	20 minutes
Three year assessment	5 day infant food diary	1 hour

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Will my child’s taking part in the study be kept confidential?
All information which is collected about you and your child during the course of the research will be kept strictly confidential. Any information which leaves the hospital will have your/your child’s name and address removed so that you cannot be recognized from it. Research folders will be labelled as confidential and kept in a locked office at all times. Access to these folders will be restricted to study investigators, study statisticians, and appointed audit authorities. The study sponsors – Kings College London and Guy’s and St Thomas’ Foundation NHS Trust may also review the records for regulatory purposes. Any information that is stored electronically will be kept ‘locked’ by password access. With your consent your GP will be informed that your child is taking part in the study and of any diagnoses (e.g. asthma or eczema) that may be made during the study.

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Can I withdraw?
You are free to withdraw from the EAT study at any time without giving reason. If you do decide to withdraw from the study we will ask you why you do not wish to continue, however you are under no obligation to give a reason. Withdrawal from the trial will not affect any entitlement to treatment for any conditions that are discovered whilst on the trial.

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What if I still have questions?
The study is now closed to new participants.