We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Mediterranean Diet Intervention in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01634516
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Allergy Behavioral: Dietary support Behavioral: No dietary support

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Primary Completion Date : July 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dietary support
Face to face intervention plus subsequent telephone support
Behavioral: Dietary support
Face to face intervention plus subsequent telephone support
Placebo Comparator: No dietary support
No face to face intervention plus subsequent telephone support
Behavioral: No dietary support
No face to face intervention or subsequent telephone support


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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 ( Other Grant/Funding Number: CSO )
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases