NCT01197196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 31, 2021

Status Verified

September 1, 2016

Enrollment Period

5.5 years

First QC Date

September 7, 2010

Last Update Submit

August 30, 2021

Conditions

MigraineObesity

Keywords

MigraineObesityWeight lossLifestyleBehavior

Outcome Measures

Primary Outcomes (1)

  • Change in the number of migraine headache days

    Measured via 28-day mobile smartphone headache diary

    Baseline, end of treatment, end of 16-week weight maintenance period

Secondary Outcomes (5)

  • Change in body weight

    baseline, end of treatment, end of 16-week weight maintenance period

  • Changes in serum inflammatory markers (C-reactive protein, Interleukin-6)

    Baseline, end of treatment

  • Changes in depression

    Baseline, end of treatment

  • Changes in physical activity

    Baseline, end of treatment

  • Changes in fat intake and other diet/eating behavior components

    Baseline, end of treatment

Other Outcomes (4)

  • Changes in additional migraine headache parameters

    Baseline, end of treatment

  • Changes in waist circumference and cardiometabolic risk factors

    Baseline, end of treatment

  • Changes in anxiety symptoms and level of psychological stress.

    Baseline, end of treatment

  • +1 more other outcomes

Study Arms (2)

Behavioral weight loss

EXPERIMENTAL
Behavioral: Behavioral Weight Loss Intervention

Migraine Education

ACTIVE COMPARATOR
Other: Migraine Education

Interventions

Behavioral Weight Loss InterventionBEHAVIORAL

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.

Behavioral weight loss
Migraine EducationOTHER

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 Education

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (7)

  • 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.

    PMID: 33823051DERIVED

  • 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.

    PMID: 32658497DERIVED

  • 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.

    PMID: 30289426DERIVED

  • 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.

    PMID: 29237284DERIVED

  • 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.

    PMID: 29178659DERIVED

  • 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.

    PMID: 26087348DERIVED

  • 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.

    PMID: 25475207DERIVED

Related Links

MeSH Terms

Conditions

Migraine DisordersObesityWeight LossBehavior

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Dale S. Bond, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

June 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 31, 2021

Record last verified: 2016-09

Locations

US(1)