MigraineNCT01197196
Behavioral Weight Loss as a Treatment for Migraine in Obese Women
A study testing Behavioral Weight Loss Intervention and Migraine Education in people with Migraine and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Behavioral Weight Loss Intervention and Migraine Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Being tested
- Behavioral Weight Loss Intervention, Migraine Education
- Keywords
- Migraine, Obesity, Weight loss, Lifestyle, Behavior
- Medical subject headings
- Migraine Disorders, Obesity, Weight Loss, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss InterventionBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral weight loss | Experimental | Not described Receives: Behavioral: Behavioral Weight Loss Intervention |
| Migraine Education | Active comparator | Not described Receives: Other: Migraine Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of migraine headache days
Measured via 28-day mobile smartphone headache diary
Measured: Baseline, end of treatment, end of 16-week weight maintenance period
Secondary outcomes (5)
Change in body weight
Measured: baseline, end of treatment, end of 16-week weight maintenance period
Changes in serum inflammatory markers (C-reactive protein, Interleukin-6)
Changes in inflammation will be tested as a mediator of the treatment effect.
Measured: Baseline, end of treatment
Changes in depression
Changes in depressive symptoms will be tested as a mediator of the treatment effect.
Measured: Baseline, end of treatment
Changes in physical activity
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.
Measured: Baseline, end of treatment
Changes in fat intake and other diet/eating behavior components
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.
Measured: Baseline, end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJun 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale S. Bond, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197196
- Sponsor's protocol ID
- 0068-10
- Other IDs
- R01NS077925-01A1
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2010
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33823051Farris 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.
PubMed 32658497Lillis 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.
PubMed 30289426Farris 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.
PubMed 29237284Bond 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.
PubMed 29178659Bond 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.
PubMed 26087348Bond 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.
PubMed 25475207
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight Loss as a Treatment for Migraine in Obese Women
- ClinicalTrials.gov ID
- NCT01197196
- Acronym / sponsor ID
- 0068-10
- Keywords
- Migraine, Obesity, Weight loss, Lifestyle, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral weight loss | Experimental | Behavioral: Behavioral Weight Loss Intervention |
| Migraine Education | Active comparator | Other: Migraine Education |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight Loss InterventionParticipants 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. | Behavioural | Behavioral weight loss |
| Migraine EducationParticipants 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. | Other | Migraine Education |
Primary outcome
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
5 secondary outcomes
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 depression
Time frame: Baseline, end of treatment
Changes in physical activity
Time frame: Baseline, end of treatment
Changes in fat intake and other diet/eating behavior components
Time frame: Baseline, end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 33823051Smith 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.
- Derived from this study: PubMed 32658497Farris 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.
- Derived from this study: PubMed 30289426Lillis 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.
- Derived from this study: PubMed 29237284Farris 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.
- Derived from this study: PubMed 29178659Bond 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.
- Derived from this study: PubMed 26087348Bond 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.
- Derived from this study: PubMed 25475207Bond 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale S. Bond, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss Intervention and Migraine Education in people with Migraine and Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of migraine headache days (time frame: Baseline, end of treatment, end of 16-week weight maintenance period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197196, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.