Behavioral Weight Loss as a Treatment for Migraine in Obese Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Miriam Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01197196
First received: September 7, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Migraine
Obesity
Behavioral: Behavioral Weight Loss Intervention
Other: Migraine Education

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 140
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)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Neurologist-confirmed diagnosis of migraine with or without aura
  • Experience at least 3 headaches and 4-14 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197196

Contacts
Contact: Dale S Bond, Ph.D. 401-793-8950 dbond@lifespan.org

Locations
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    dbond@lifespan.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.         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Dale S. Bond, Ph.D. The Miriam Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01197196     History of Changes
Other Study ID Numbers: 0068-10, 1R01NS077925-01A1
Study First Received: September 7, 2010
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Migraine
Obesity
Weight loss
Lifestyle
Behavior

Additional relevant MeSH terms:
Obesity
Weight Loss
Migraine Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014