Migraine | Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Migraine research study
What is the primary objective of this study?
This study involves a randomized controlled trial to test the efficacy of behavioral weight loss as a treatment for migraine in obese females aged 18 to 50 years. The primary aim is to examine whether participants assigned to a behavioral weight loss treatment condition report greater pre- to post-treatment reductions in migraine headache frequency than participants assigned to a migraine education condition.
Who is eligible to participate?
Inclusion criteria: - Neurologist-confirmed diagnosis of migraine with or without aura - Experience at least 3 headaches and 4-20 headache days per month - Body Mass Index of 25.0-49.9 kg/m2 Exclusion criteria: - Have primary headache disorder other than migraine or tension-type headache - Have both migraine and tension-type headache and are unable to distinguish the two headache types and/or report 2 or more tension-type headaches per month - Have a secondary headache disorder - Have initiated or changed prophylactic medications within 2 months of study entry, or intend to change these medications during the trial - Have changed medications used to abort migraine attacks, treat depression, or provide oral contraception within 2 months of study entry, or intend to change these medications during the trial. - Have experienced recent weight loss (>=5% within the past 6 months), are currently involved in a commercial weight loss program, are presently taking weight loss medications, or have had bariatric surgery. - Are pregnant, were pregnant within the last 6 months, or plan to become pregnant during the trial. - Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire. Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise participation will be required to obtain written physician consent to participate. - Have been diagnosed with cancer or are currently undergoing cancer treatment. - Are unable to read or understand the study materials. - Report any condition that in the opinion of investigators would reduce the likelihood of adherence to the headache monitoring protocol or clinical trial prescriptions, including terminal illness, planning to relocate, or a history of substance abuse, bulimia nervosa, or other significant psychiatric problems.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Behavioral Weight Loss InterventionParticipants assigned to this condition will receive an intensive group-based lifestyle program modeled after the DPP and Look AHEAD trials. Participants will attend 16 weekly sessions involving provision of behavioral goals and strategies to modify diet and exercise behaviors in order to achieve a weight loss of at least 7% of initial body weight.
Other:Migraine EducationParticipants assigned to this condition (Healthy Living for Migraine Relief [HLMR]) will receive basic education and didactic instruction in migraine headaches and treatments that are the standard of care. Participants will attend 4 months of weekly group lectures focused on 3 different major topic areas: 1) migraine symptomatology and pathophysiology, 2) standard abortive and preventive pharmacological treatment options, and 3) standard and alternative non-pharmacological treatment options.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Behavioral weight loss
Start Date: July 2012
Completed Date: June 2017
Primary Outcome: Change in the number of migraine headache days
Secondary Outcome: Change in body weight
Study sponsors, principal investigator, and references
Principal Investigator: Dale S. Bond, Ph.D.
Lead Sponsor: The Miriam Hospital
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)