NCT01634516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

July 3, 2012

Last Update Submit

August 11, 2017

Conditions

Allergy

Keywords

DietPregnant

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease.

    4 months

Secondary Outcomes (1)

  • Mediterranean Diet score in pregnancy

    12 and 24 weeks post-intervention

Study Arms (2)

Dietary support

EXPERIMENTAL

Face to face intervention plus subsequent telephone support

Behavioral: Dietary support

No dietary support

PLACEBO COMPARATOR

No face to face intervention plus subsequent telephone support

Behavioral: No dietary support

Interventions

Dietary supportBEHAVIORAL

Face to face intervention plus subsequent telephone support

Dietary support
No dietary supportBEHAVIORAL

No face to face intervention or subsequent telephone support

No dietary support

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leith Community Treatment Centre

Edinburgh, Scotland, United Kingdom

Location

St John's Hospital

Livingston, Scotland, EH54 6PP, United Kingdom

Location

Related Publications (2)

  • Sewell DA, Hammersley VS, Devereux G, Robertson A, Stoddart A, Weir C, Worth A, Sheikh A. Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial. Trials. 2013 Jun 14;14:173. doi: 10.1186/1745-6215-14-173.

    PMID: 23768094BACKGROUND

  • Sewell DA, Hammersley VS, Robertson A, Devereux G, Stoddart A, Weir CJ, Worth A, Sheikh A. A pilot randomised controlled trial investigating a Mediterranean diet intervention in pregnant women for the primary prevention of allergic diseases in infants. J Hum Nutr Diet. 2017 Oct;30(5):604-614. doi: 10.1111/jhn.12469. Epub 2017 Feb 16.

    PMID: 28211106BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Dean A. Sewell, PhD

    Heriot-Watt University

    PRINCIPAL INVESTIGATOR

  • Aziz Sheikh, MBBS, MD

    University of Edinburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Human Physiology and Metabolism

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2014

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)