Background: Over recent decades there has been a substantial increase in asthma and allergic disease especially in children. Given the high prevalence, and the associated high disease burden and costs, there is a need to identify effective strategies for the primary prevention of asthma and allergy. A recent systematic review of the literature found strong supportive epidemiological evidence for a protective role of the Mediterranean diet, which now needs to be confirmed through formal experimental studies. This pilot trial in pregnant women aims to establish recruitment, retention and acceptability of a dietary intervention, and to assess the likely impact of the intervention on adherence to a Mediterranean diet during pregnancy.Methods/Design: This study was a pilot, two-arm, randomised controlled trial in a sample population of pregnant women at high risk of having a child who will develop asthma or allergic disease.Discussion: The work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned large-scale, parallel group, randomised controlled trial.Trial registration: ClinicalTrials.gov: NCT01634516.
Bibliographical noteThis research is funded by the Chief Scientist Office of The Scottish Government/Chief Medical Officer Directorate (Grant CZG/2/558). The authors would like to acknowledge the staff involved in the NHS ethical and research and development review processes, and staff at the Health Records Department of the Edinburgh Royal Infirmary for their help in getting the recruitment material to potential participants. The staff at the ultrasound/X-ray clinics at the two NHS Lothian sites where the participants are met by the researcher are most helpful and accommodating. The authors thank Anne Galloway (dietitian) who, when available, is delivering the intervention at one of the sites. They would also like to thank the participants for volunteering to take part, Dr Rob Elton the independent statistician, and Julia Clark (dietitian), Dr Ulugbek Nurmatov (researcher), and our Consumer Involvement Group for their input.
- Mediterranean diet