Effectiveness of Mediterranean Diet Intervention in Pregnant Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
Dean A. Sewell, Heriot-Watt University
ClinicalTrials.gov Identifier:
NCT01634516
First received: July 3, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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 Heriot-Watt University:

Primary Outcome Measures:
  • Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mediterranean Diet score in pregnancy [ Time Frame: 12 and 24 weeks post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01634516

Locations
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
Investigators
Principal Investigator: Dean A. Sewell, PhD Heriot-Watt University
Study Chair: Aziz Sheikh, MBBS, MD University of Edinburgh
  More Information

No publications provided by Heriot-Watt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dean A. Sewell, Senior Lecturer in Human Physiology and Metabolism, Heriot-Watt University
ClinicalTrials.gov Identifier: NCT01634516     History of Changes
Other Study ID Numbers: HWU113821/UoE, CZG/2/558
Study First Received: July 3, 2012
Last Updated: June 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Heriot-Watt University:
Diet
Pregnant

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014