Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: Protocol for a pilot randomised controlled trial

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.