A Pilot Study of Migraine and Appetite Behaviour in Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930852
• Other study ID #: 09/H1017/51
• Secondary ID: 09/15/RE
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: February 19, 2012
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2012
• Source: Alder Hey Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Migraine Disorders
• Obesity

Locations

Country	Name	City	State
United Kingdom	Alder Hey Children's Hospital	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Alder Hey Children's NHS Foundation Trust	University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	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.			No
Secondary	Descriptive analysis of type and severity of typical food cravings and dietary habits using the Food Craving Inventory score and a food intake questionnaire.			No