Behavioral Weight Loss as a Treatment for Migraine in Obese Women

Not Applicable

Completed

• Conditions: Migraine; Obesity
• Interventions: Other: Migraine Education; Behavioral: Behavioral Weight Loss Intervention

• Registration Number: NCT01197196
• Lead Sponsor: The Miriam Hospital

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 Timeline

• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Study Start: 2012-06
• Status Verified: 2016-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine Education	Migraine Education	-
Behavioral weight loss	Behavioral Weight Loss Intervention	-

Primary Outcome Measures

Name	Time	Method
Change in the number of migraine headache days	Baseline, end of treatment, end of 16-week weight maintenance period	Measured via 28-day mobile smartphone headache diary

Secondary Outcome Measures

Name	Time	Method
Changes in physical activity	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 serum inflammatory markers (C-reactive protein, Interleukin-6)	Baseline, end of treatment	Changes in inflammation will be tested as a mediator of the treatment effect.
Changes in depression	Baseline, end of treatment	Changes in depressive symptoms will be tested as a mediator of the treatment effect.
Changes in fat intake and other diet/eating behavior components	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.
Change in body weight	baseline, end of treatment, end of 16-week weight maintenance period

Trial Locations

Locations (1)

The Miriam Hospital Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States