Clinical trial NCT00930852: A Pilot Study of Migraine and Appetite Behaviour in Children
Official title: Migraine, Appetite Behaviour and Obesity: is There a Link?. A Pilot Study of Migraine and Appetite Behaviour in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Obesity
Keywords: Migraine
Children
Primary headache disorders
Appetite
Obesity
Feeding Behavior
Lead sponsor: Alder Hey Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Liverpool
First posted: 2009-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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 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.

Primary outcomes:
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 outcomes:
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.
measure: Descriptive analysis of type and severity of typical food cravings and dietary habits using the Food Craving Inventory score and a food intake questionnaire.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: Merseyside
Study officials:
affiliation: Alder Hey Children's NHS Foundation Trust
name: Ram Kumar, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bigal ME, Lipton RB, Holland PR, Goadsby PJ. Obesity, migraine, and chronic migraine: possible mechanisms of interaction. Neurology. 2007 May 22;68(21):1851-61. doi: 10.1212/01.wnl.0000262045.11646.b1.
citation: Carnell S, Wardle J. Appetite and adiposity in children: evidence for a behavioral susceptibility theory of obesity. Am J Clin Nutr. 2008 Jul;88(1):22-9. doi: 10.1093/ajcn/88.1.22.
citation: Pinhas-Hamiel O, Frumin K, Gabis L, Mazor-Aronovich K, Modan-Moses D, Reichman B, Lerner-Geva L. Headaches in overweight children and adolescents referred to a tertiary-care center in Israel. Obesity (Silver Spring). 2008 Mar;16(3):659-63. doi: 10.1038/oby.2007.88. Epub 2008 Jan 17.