A Pilot Study of Migraine and Appetite Behaviour in Children

This study has been completed.
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00930852
First received: June 30, 2009
Last updated: February 19, 2012
Last verified: February 2012
  Purpose

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.


Condition
Migraine Disorders
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Migraine, Appetite Behaviour and Obesity: is There a Link?. A Pilot Study of Migraine and Appetite Behaviour in Children.

Resource links provided by NLM:


Further study details as provided by Alder Hey Children's NHS Foundation Trust:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]
  • Descriptive analysis of type and severity of typical food cravings and dietary habits using the Food Craving Inventory score and a food intake questionnaire. [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930852

Locations
United Kingdom
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
University of Liverpool
Investigators
Principal Investigator: Ram Kumar, MRCP Alder Hey Children's NHS Foundation Trust
  More Information

Publications:
Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00930852     History of Changes
Other Study ID Numbers: 09/H1017/51, 09/15/RE
Study First Received: June 30, 2009
Last Updated: February 19, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Alder Hey Children's NHS Foundation Trust:
Migraine
Children
Primary headache disorders
Appetite
Obesity
Feeding Behavior

Additional relevant MeSH terms:
Obesity
Migraine Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014