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Effectiveness of Mediterranean Diet Intervention in Pregnant Women

This study has been completed.
University of Edinburgh
Information provided by (Responsible Party):
Dean A. Sewell, Heriot-Watt University Identifier:
First received: July 3, 2012
Last updated: March 30, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Allergy Behavioral: Dietary support Behavioral: No dietary support Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Dean A. Sewell, Heriot-Watt University:

Primary Outcome Measures:
  • Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Mediterranean Diet score in pregnancy [ Time Frame: 12 and 24 weeks post-intervention ]

Enrollment: 30
Study Start Date: May 2012
Study Completion Date: August 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant in first trimester
  • Age 16 years and above
  • One or more first degree blood relatives of the baby with atopic dermatitis(eczema), food allergy, allergic rhinitis (persistent or intermittent) or asthma
  • Willing to give informed consent

Exclusion Criteria:

  • Age <16 years
  • No first degree blood relatives of the baby with atopic dermatitis (eczema), food allergy, allergic rhinitis (persistent or intermittent) or asthma
  • Recent (within the last 3 months) or current involvement in a dietary or supplementation trial
  • Unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01634516

United Kingdom
Leith Community Treatment Centre
Edinburgh, Scotland, United Kingdom
St John's Hospital
Livingston, Scotland, United Kingdom, EH54 6PP
Sponsors and Collaborators
Heriot-Watt University
University of Edinburgh
Principal Investigator: Dean A. Sewell, PhD Heriot-Watt University
Study Chair: Aziz Sheikh, MBBS, MD University of Edinburgh
  More Information

Responsible Party: Dean A. Sewell, Senior Lecturer in Human Physiology and Metabolism, Heriot-Watt University Identifier: NCT01634516     History of Changes
Other Study ID Numbers: HWU113821/UoE
CZG/2/558 ( Other Grant/Funding Number: CSO )
Study First Received: July 3, 2012
Last Updated: March 30, 2015

Keywords provided by Dean A. Sewell, Heriot-Watt University:

Additional relevant MeSH terms:
Immune System Diseases processed this record on June 28, 2017