A Pilot Study of Migraine and Appetite Behaviour in Children

February 19, 2012 updated by: Alder Hey Children's NHS Foundation Trust

Migraine, Appetite Behaviour and Obesity: is There a Link?. A Pilot Study of Migraine and Appetite Behaviour in Children.

The purpose of this study is to determine whether there is an association between migraine in children and certain patterns of appetite or eating behaviour that may lead to later obesity.

Study Overview

Status

Completed

Conditions

Detailed Description

Migraine is a chronic neurological disorder characterized by recurrent episodes of headache and associated symptoms. The condition affects approximately 11% of the child population and it can impose considerable burdens on the sufferer either due to the headache itself, or associated co-morbidities such as psychological stress, obesity, sleep problems, etc. Increasing attention is focussing on the shared genetic, environmental and neurobiological mechanisms of migraine co-morbidities to gain further insights into improving outcomes.

We are interested in studying eating behaviours in children with migraine since there is evidence that altered patterns of eating behaviour (and underlying changes in appetite) are seen in migraineurs although not studied systematically. Altered appetite and eating behaviours may be a mechanism for the emerging association between obesity (or degree of adiposity) and migraine severity, detected in both adult and paediatric studies to varying extents. Studying the putative association between migraine, degree of adiposity and patterns of eating behaviour in children may help to tease out causal mechanisms, since both migraine and obesity often evolve over the course of childhood.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

New referrals to outpatient general paediatric and paediatric neurology service (both accepting primary care referrals) within a single multispecialty children's hospital.

Description

Inclusion Criteria:

  • Children and adolescents between 5 years and 16 years of age.
  • Clinical diagnosis of migraine (for cases).
  • Controls are recruited from children referred with headache, who do not receive diagnosis of migraine.

Exclusion Criteria:

  • Adolescents 17 years or over.
  • Secondary migraine-like disorder e.g., post-craniotomy headache.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pearson's correlation between PedMIDAS score (measure of migraine severity) and eating behaviour subscale score on the Child Eating Behaviour Questionnaire or Dutch Eating Behaviour Questionnaire.

Secondary Outcome Measures

Outcome Measure
Regression coefficient of PedMIDAS score or categories of headache frequency on eating behaviour subscale scores, with covariates of Achenbach Child Behavior Checklist score, current BMI, age, sex, length of history of migraine.
Descriptive analysis of type and severity of typical food cravings and dietary habits using the Food Craving Inventory score and a food intake questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Hey Children's NHS Foundation Trust

Collaborators

University of Liverpool

Investigators

  • Principal Investigator: Ram Kumar, MRCP, Alder Hey Children's NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 19, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H1017/51
  • 09/15/RE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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