Behavioral Weight Loss as a Treatment for Migraine in Obese Women
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.
Behavioral: Behavioral Weight Loss Intervention
Other: Migraine Education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Behavioral Weight Loss as a Treatment for Migraine in Obese Women|
- Change in the number of migraine headache days [ Time Frame: Baseline, end of treatment, end of 16-week weight maintenance period ] [ Designated as safety issue: No ]Measured via 28-day mobile smartphone headache diary
- Change in body weight [ Time Frame: baseline, end of treatment, end of 16-week weight maintenance period ] [ Designated as safety issue: No ]
- Changes in serum inflammatory markers (C-reactive protein, Interleukin-6) [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Changes in inflammation will be tested as a mediator of the treatment effect.
- Changes in depression [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Changes in depressive symptoms will be tested as a mediator of the treatment effect.
- Changes in physical activity [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Physical activity will be objectively assessed via a multi-sensor monitor. Changes in physical activity will be tested as a mediator of the treatment effect.
- Changes in fat intake and other diet/eating behavior components [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Diet and eating behavior will be measured via a multi-call 24 hour dietary recall procedure. Changes in fat intake will be tested as as mediator of the treatment effect.
- Changes in additional migraine headache parameters [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Additional headache parameters include daily headache activity (severity and duration of attacks, clinical features (photophobia, phonophobia, nausea), abortive medication usage, allodynia, and headache management self-efficacy.
- Changes in waist circumference and cardiometabolic risk factors [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Cardiometabolic risk factors will include systolic and diastolic blood pressure, total and HDL cholesterol, triglycerides, and insulin sensitivity.
- Changes in anxiety symptoms and level of psychological stress. [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]
- Changes in sleep quality [ Time Frame: Baseline, end of treatment ] [ Designated as safety issue: No ]Sleep duration and quality will be assessed via self-report and objectively using a multi-sensor monitor.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
|Experimental: Behavioral weight loss||
Behavioral: Behavioral Weight Loss Intervention
Participants 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.
|Active Comparator: Migraine Education||
Other: Migraine Education
Participants 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197196
|Contact: Dale S Bond, Ph.D.||email@example.com|
|United States, Rhode Island|
|The Miriam Hospital Weight Control and Diabetes Research Center||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Dale S Bond, Ph.D. 401-793-8950 firstname.lastname@example.org|
|Principal Investigator: Dale S. Bond, Ph.D.|
|Sub-Investigator: Graham Thomas, Ph.D.|
|Sub-Investigator: Rena R Wing, Ph.D.|
|Sub-Investigator: George D Papandonatos, Ph.D.|
|Sub-Investigator: Julie Roth, M.D.|
|Sub-Investigator: Richard B Lipton, M.D.|
|Principal Investigator:||Dale S. Bond, Ph.D.||The Miriam Hospital|