Migraine DisordersNCT00930852
A Pilot Study of Migraine and Appetite Behaviour in Children
An observational study of Migraine Disorders and Obesity, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Migraine Disorders, Obesity
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: New referrals to outpatient general paediatric and paediatric neurology service (both accepting primary care referrals) within a single multispecialty children's hospital.
Who may be able to join
- 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.
Who cannot join
- Adolescents 17 years or over.
- Secondary migraine-like disorder e.g., post-craniotomy headache.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Alder Hey Children's Hospital
Liverpool, Merseyside, L12 2AP
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine Disorders, Obesity
- Keywords
- Migraine, Children, Primary headache disorders, Appetite, Obesity, Feeding Behavior
- Medical subject headings
- Migraine Disorders, Obesity, Headache Disorders, Primary, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alder Hey Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Ram Kumar, MRCP, Principal investigator, Alder Hey Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930852
- Sponsor's protocol ID
- 09/H1017/51
- Other IDs
- 09/15/RE
- Status last verified
- Feb 2012
- First submitted
- 30 Jun 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17515549Carnell 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.
PubMed 18614720Pinhas-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.
PubMed 18239560
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine, Appetite Behaviour and Obesity: is There a Link?. A Pilot Study of Migraine and Appetite Behaviour in Children.
- ClinicalTrials.gov ID
- NCT00930852
- Acronym / sponsor ID
- 09/H1017/51
- Conditions
- Migraine Disorders, Obesity
- Keywords
- Migraine, Children, Primary headache disorders, Appetite, Obesity, Feeding Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alder Hey Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- New referrals to outpatient general paediatric and paediatric neurology service (both accepting primary care referrals) within a single multispecialty children's hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Adolescents 17 years or over.
- Secondary migraine-like disorder e.g., post-craniotomy headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Background: PubMed 17515549Bigal 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.
- Background: PubMed 18614720Carnell 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.
- Background: PubMed 18239560Pinhas-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Kumar, MRCP principal investigator
Alder Hey Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Obesity, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930852, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.