Clinical trial NCT01197196: Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Official title: Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Obesity
Keywords: Migraine
Obesity
Weight loss
Lifestyle
Behavior
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-09-09
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 pain episodes involving nausea, photophobia, phonophobia and aversion to physical activity.

There is increasing evidence that obesity exacerbates migraine. Obesity is associated with more frequent headaches in episodic migraineurs, and is a risk factor for progression to chronic migraine. Several plausible mechanisms have been proposed to underlie the migraine-obesity link including common pro-inflammatory processes, psychological conditions that are comorbid to both disorders (e.g., depression), and similar behavioral risk factors (e.g., low physical activity and high fat intake).

No research to date has examined the impact of standard behavioral weight loss programs on migraine in obese adults. Behavioral weight loss programs focused on improving diet and physical activity consistently produce weight losses of 8-10 kg at 6 months which reduces the risk of diabetes and improves cardiovascular disease risk factors. Weight loss may also improve each of the physiological, psychological, and behavioral pathways that purportedly link migraine and obesity. Thus, behavioral weight loss programs may serve as an innovative approach to treating migraine headaches.

This study involves a randomized controlled trial to examine the efficacy of behavioral weight loss as a treatment for migraine. One hundred and forty obese females who meet research criteria for migraine, as confirmed by a study neurologist and completion of an electronic headache diary will be assigned to 16 weekly group sessions of either: (1) Behavioral weight loss (BWL) treatment (n=70) or (2) Healthy Living for Migraine Relief (HLMR) education (n=70). BWL will provide a combination of empirically validated diet and exercise prescriptions and behavior change strategies such as self-monitoring, goal-setting and stimulus control. HLMR will provide education on migraine and pharmacological and behavioral (e.g., stress management) treatments. Both groups will use smartphones to record their headaches for 4 weeks at a time during pre-treatment, post-treatment, and the end of a 16-week weight maintenance period. Weight and other potential physiological (inflammation), psychological (depression), and behavioral (diet and physical activity) mediators of the treatment effect will be assessed at the end of treatment for tests of prospective effects on migraine days at post-treatment. The primary hypothesis is that BWL participants will report greater pre- to post-treatment reductions in number of migraine days than HLMR participants.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the number of migraine headache days
timeFrame: Baseline, end of treatment, end of 16-week weight maintenance period
Secondary outcomes:
measure: Change in body weight
timeFrame: baseline, end of treatment, end of 16-week weight maintenance period
measure: Changes in serum inflammatory markers (C-reactive protein, Interleukin-6)
timeFrame: Baseline, end of treatment
measure: Changes in depression
timeFrame: Baseline, end of treatment
measure: Changes in physical activity
timeFrame: Baseline, end of treatment
measure: Changes in fat intake and other diet/eating behavior components
timeFrame: Baseline, end of treatment
Other outcomes:
measure: Changes in additional migraine headache parameters
timeFrame: Baseline, end of treatment
measure: Changes in waist circumference and cardiometabolic risk factors
timeFrame: Baseline, end of treatment
measure: Changes in anxiety symptoms and level of psychological stress.
timeFrame: Baseline, end of treatment
measure: Changes in sleep quality
timeFrame: Baseline, end of treatment
Locations:
city: Providence
country: United States
facility: The Miriam Hospital Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Dale S. Bond, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith KE, Thomas JG, Steffen KJ, Lipton RB, Farris SG, Pavlovic JM, Bond DS. Naturalistic assessment of patterns and predictors of acute headache medication use among women with comorbid migraine and overweight or obesity. Transl Behav Med. 2021 Aug 13;11(8):1495-1506. doi: 10.1093/tbm/ibab027.
citation: Farris SG, Thomas JG, Kibbey MM, Pavlovic JM, Steffen KJ, Bond DS. Treatment effects on pain catastrophizing and cutaneous allodynia symptoms in women with migraine and overweight/obesity. Health Psychol. 2020 Oct;39(10):927-933. doi: 10.1037/hea0000920. Epub 2020 Jul 13.
citation: Lillis J, Thomas JG, Lipton RB, Rathier L, Roth J, Pavlovic J, O'Leary KC, Bond DS. The Association of Changes in Pain Acceptance and Headache-Related Disability. Ann Behav Med. 2019 Jun 4;53(7):686-690. doi: 10.1093/abm/kay076.
citation: Farris SG, Thomas JG, Abrantes AM, Lipton RB, Pavlovic J, Smitherman TA, Irby MB, Penzien DB, Roth J, O'Leary KC, Bond DS. Pain worsening with physical activity during migraine attacks in women with overweight/obesity: A prospective evaluation of frequency, consistency, and correlates. Cephalalgia. 2018 Oct;38(11):1707-1715. doi: 10.1177/0333102417747231. Epub 2017 Dec 13.
citation: Bond DS, Thomas JG, Lipton RB, Roth J, Pavlovic JM, Rathier L, O'Leary KC, Evans EW, Wing RR. Behavioral Weight Loss Intervention for Migraine: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Jan;26(1):81-87. doi: 10.1002/oby.22069. Epub 2017 Nov 27.
citation: Bond DS, Buse DC, Lipton RB, Thomas JG, Rathier L, Roth J, Pavlovic JM, Evans EW, Wing RR. Clinical Pain Catastrophizing in Women With Migraine and Obesity. Headache. 2015 Jul-Aug;55(7):923-33. doi: 10.1111/head.12597. Epub 2015 Jun 18.
citation: Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4.