Behavioral Weight Loss as a Treatment for Migraine in Obese Women

Completed · Not applicable

Conditions studied: Migraine, Obesity

In brief

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.

Key facts

Study ID

NCT01197196

Run by

The Miriam Hospital

People needed

112

Starts

2012-06-01

Expected to finish

2017-12-01

Last updated by the study team

2021-08-31

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Miriam Hospital Weight Control and Diabetes Research Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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