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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.