Effectiveness of Mediterranean Diet Intervention in Pregnant Women
There has been an increase in asthma and allergic disease prevalence, especially in children. Given the high prevalence, and the associated high disease burden and costs, there is an urgent need to identify effective strategies for the primary prevention of asthma and allergy. A systematic review of the literature has found strong supportive epidemiological evidence of a protective role for the Mediterranean Diet (MD).
The investigators aim is to undertake a pilot trial in a sample of pregnant women to establish recruitment, retention, a measurable change to a dietary intervention encouraging greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet modifications.
This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of around 50 Scottish pregnant women.
This 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 definitive parallel group RCT.
|Allergy||Behavioral: Dietary support Behavioral: No dietary support||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Investigation of the Effectiveness of the Mediterranean Diet in Pregnant Women at Risk of Developing Allergy in Their Infants: Pilot Randomised Controlled Trial|
- Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease. [ Time Frame: 4 months ]
- Mediterranean Diet score in pregnancy [ Time Frame: 12 and 24 weeks post-intervention ]
|Study Start Date:||May 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Dietary support||
Behavioral: Dietary support
Face to face intervention plus subsequent telephone support
|Placebo Comparator: No dietary support||
Behavioral: No dietary support
No face to face intervention or subsequent telephone support
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634516
|Leith Community Treatment Centre|
|Edinburgh, Scotland, United Kingdom|
|St John's Hospital|
|Livingston, Scotland, United Kingdom, EH54 6PP|
|Principal Investigator:||Dean A. Sewell, PhD||Heriot-Watt University|
|Study Chair:||Aziz Sheikh, MBBS, MD||University of Edinburgh|