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Behavioral Weight Loss as a Treatment for Migraine in Obese Women

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ClinicalTrials.gov Identifier: NCT01197196
Recruitment Status : Unknown
Verified September 2016 by The Miriam Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE September 7, 2010
First Posted Date  ICMJE September 9, 2010
Last Update Posted Date December 21, 2016
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
Change in the number of migraine headache days [ Time Frame: Baseline, end of treatment, end of 16-week weight maintenance period ]
Measured via 28-day mobile smartphone headache diary
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
Change from baseline to 20 week endpoint in the number of migraine headaches (measured via 28-day diary) [ Time Frame: Baseline, 20 weeks ]
Change History Complete list of historical versions of study NCT01197196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • Change in body weight [ Time Frame: baseline, end of treatment, end of 16-week weight maintenance period ]
  • Changes in serum inflammatory markers (C-reactive protein, Interleukin-6) [ Time Frame: Baseline, end of treatment ]
    Changes in inflammation will be tested as a mediator of the treatment effect.
  • Changes in depression [ Time Frame: Baseline, end of treatment ]
    Changes in depressive symptoms will be tested as a mediator of the treatment effect.
  • Changes in physical activity [ Time Frame: Baseline, end of treatment ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
  • Change from baseline to 20 week endpoint in migraine headache severity (measured via 28-day diary) [ Time Frame: Baseline, 20 weeks ]
  • Change in headache disability from baseline to 20 week endpoint [ Time Frame: Baseline, 20 weeks ]
    Measures of headache disability include: Migraine Disability Assessment questionnaire (MIDAS) and Headache Impact Test-6 (HIT-6)
Current Other Pre-specified Outcome Measures
 (submitted: October 31, 2012)
  • Changes in additional migraine headache parameters [ Time Frame: Baseline, end of treatment ]
    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 ]
    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 ]
  • Changes in sleep quality [ Time Frame: Baseline, end of treatment ]
    Sleep duration and quality will be assessed via self-report and objectively using a multi-sensor monitor.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Official Title  ICMJE Behavioral Weight Loss as a Treatment for Migraine in Obese Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Behavioral weight loss
    Intervention: Behavioral: Behavioral Weight Loss Intervention
  • Active Comparator: Migraine Education
    Intervention: Other: Migraine Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
112
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2010)
30
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01197196
Other Study ID Numbers  ICMJE 0068-10
R01NS077925-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Dale S. Bond, Ph.D. The Miriam Hospital
PRS Account The Miriam Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP