Status:
COMPLETED
Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Migraine
Obesity
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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...
Detailed Description
Migraine is a highly prevalent, debilitating and costly disorder. Eighteen percent of women and 6% of men are affected by migraine; a neurovascular disorder characterized by severe recurrent headache ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01197196
Start Date
June 1 2012
End Date
December 1 2017
Last Update
August 31 2021
Active Locations (1)
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1
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903