title: A pilot randomised controlled trial investigating a Mediterranean diet intervention in pregnant women for the primary prevention of allergic diseases in infants.
abstract: Observational studies suggest a potentially protective role of the Mediterranean diet (MD) in allergic diseases, including asthma. Large scale randomised controlled trials (RCTs) are needed to test the hypothesised allergy-prevention benefits of a MD during pregnancy. The present two-arm pilot RCT in pregnant women at high-risk of having a child who would develop allergic disease investigated maternal recruitment, retention and acceptability of an MD dietary intervention in the UK. The trial also assessed the effect of the intervention on MD adherence scores at 12 and at 24 weeks post-randomisation.
  
  
  
  Thirty women were recruited at around 12 weeks of gestation. Retention was high (28 out of 30; 93%). The intervention was acceptable to participants. Mean (SD) adherence to the MD at baseline was 12.4 (2.9) in the intervention arm (n = 14) and 13.0 (1.9) in the control arm (n = 16), where 24 represents maximal adherence. There was a favourable short-term change in MD score: the adjusted mean difference (intervention - control) in the change in MD score from baseline to 12 weeks post-randomisation was 2.4 (95% confidence interval = 0.6-4.2, P = 0.012).
  
  
  
  The trial provides important insights into recruitment, retention and sustaining the dietary intervention, which will be used in the design of a large RCT.
authors.affiliation: School of Energy, Geosciences, Infrastructure and Society, Heriot-Watt University, Edinburgh, UK.
authors.forename: D A
authors.initials: DA
authors.lastname: Sewell
authors.affiliation: School of Energy, Geosciences, Infrastructure and Society, Heriot-Watt University, Edinburgh, UK.|Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.
authors.forename: V S
authors.initials: VS
authors.lastname: Hammersley
authors.affiliation: Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.
authors.forename: A
authors.initials: A
authors.lastname: Robertson
authors.affiliation: Child Health, University of Aberdeen, Royal Aberdeen Children's Hospital, Aberdeen, UK.
authors.forename: G
authors.initials: G
authors.lastname: Devereux
authors.affiliation: Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.|Edinburgh Health Services Research Unit, Edinburgh, UK.
authors.forename: A
authors.initials: A
authors.lastname: Stoddart
authors.affiliation: Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.|Edinburgh Health Services Research Unit, Edinburgh, UK.
authors.forename: C J
authors.initials: CJ
authors.lastname: Weir
authors.affiliation: Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.|Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh, UK.
authors.forename: A
authors.initials: A
authors.lastname: Worth
authors.affiliation: Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Edinburgh, UK.
authors.forename: A
authors.initials: A
authors.lastname: Sheikh
mesh_terms: D000080242:8-Hydroxy-2'-Deoxyguanosine; D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood / Q000652:urine; D003849:Deoxyguanosine / Q000031:analogs & derivatives / Q000652:urine; D004032:Diet; D038441:Diet, Mediterranean; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000517:prevention & control*; D007223:Infant; D008297:Male; D009566:Nitrates / Q000097:blood; D009609:Nitrous Oxide / Q000097:blood; D015596:Nutrition Assessment; D010865:Pilot Projects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011322:Primary Prevention; D055815:Young Adult
chemical_list: D015415:Biomarkers; D009566:Nitrates; D000080242:8-Hydroxy-2'-Deoxyguanosine; D003849:Deoxyguanosine; D009609:Nitrous Oxide
keywords: allergy; asthma; diet; mediterranean; pregnancy