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 | Â | 3 days every 4 weeks |
BMI, BP, Weight | Week 5-6 | Weeks 10, 14, and 18 |
Effect modification measures | ||
Demographics | Week 0 | Â |
Clinical Characteristics | Week 0 | Â |
Expectation of benefit†|  | After dietary instruction |