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Effectiveness of Mediterranean Diet Intervention in Pregnant Women

NCT01634516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-14

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

BEHAVIORAL

Dietary support

Face to face intervention plus subsequent telephone support

BEHAVIORAL

No dietary support

No face to face intervention or subsequent telephone support

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • Heriot-Watt University

    lead OTHER

Principal Investigators

  • Dean A. Sewell, PhD · Heriot-Watt University

  • Aziz Sheikh, MBBS, MD · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-07-31
Completion
2014-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01634516 on ClinicalTrials.gov