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Table 3 Summary of measures and timing of administration for exploratory analgesic dietary intervention for chronic daily headache as of May 2010

From: Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

Variable or Instrument

Usual Care - UC

Weeks 0 to 6

UC + Diet

Weeks 6 to 18

Primary outcome

Headache QOL - HIT-6 §

Week 0, Week 6

Week 18

Secondary outcomes

Headache Diary: Frequency

Daily

Daily

Perceived clinical change

Week 0, Week 6

Week 18

Headache disability - MIDAS#

Week 6

Week 18

Headache Diary: Intensity/Duration

Daily

Daily

Headache Diary: Sleep Duration

Daily

Daily

Headache Diary: Medication Use/Cost

Daily

Daily

Headache Diary: Health care visits

Daily

Daily

Satisfaction with care

Week 0, Week 6

Week 18

Psychological health: BSI-18

Week 0, Week 6

Week 18

Health status: Rand SF-12

Week 0, Week 6

Week 18

Process measures

Nutritional and Metabolic Biomarkers

Week 6

Weeks 10, 14, and 18

Dietary Intake Assessment

Week 5-6

Week 16-18

Food Intake Diary

 

3 days every 4 weeks

BMI, BP, Weight

Week 5-6

Weeks 10, 14, and 18

Effect modification measures

Demographics

Week 0

 

Clinical Characteristics

Week 0

 

Expectation of benefit†

 

After dietary instruction

  1. *International Classification of Headache Disorders, defined by expert members of the International Headache Society
  2. † Based on a measure developed by Borkovec and Nau to measure credibility of psychological interventions.
  3. § Headache Impact Test was developed to measure headache-related quality of life.
  4. # Migraine disability assessment score assesses the number of days of missed work or school in the past 3 months.