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Table 3 Primary, secondary, and other outcome measures

From: Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial

Primary outcome measures:
 • Mediterranean Diet Adherence Screener (MEDAS) score
 • Body mass index (BMI)
 • Ventilatory threshold 1 (VT1) determined by bicycle spiroergometry
For all three outcome measures, the change between baseline and 12 months will be analyzed.
Secondary outcome measures:
Psychology:
 • Stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire
 • Grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire
 • Quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Physical activity:
 • Maximum oxygen consumption (VO2 peak), as measured by spiroergometry
 • Oxygen consumption (VO2) and watts at ventilation threshold 1 (VT1 and VT2), as measured by spiroergometry
 • Physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)
Nutrition:
 • Mediterranean Diet Adherence Screener (MEDAS) score
 • Dietary habits and calorie intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ)
 • BMI
Breast cancer incidence and mortality
 • Breast cancer incidence
 • Overall and breast cancer mortality rate
Other outcome measures:
 • Attitudes and beliefs regarding physical training and healthy diet, as measured by the “Bewertung koerperlicher Aktivitaet und Ernaehrung” (BKAE) questionnaire
 • Satisfaction with the study
 • Body fat content, as measured by skinfold measurement
 • Tobacco and alcohol consumption
 • Omega 3, 6, and 9 fatty acids in the erythrocyte membrane
 • Serum cholesterol including serum high- and low-density lipoprotein cholesterol
 • Serum triglycerides, glucose, high-sensitivity C-reactive protein, and insulin
 • Serum proenkephalin and proneurotensin
 • Hospitalization days for breast cancer
If appropriate, secondary and other outcome measures will be analyzed as the change from baseline over time of all available time points.