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Table 1 Schedule of enrolment, interventions, and assessments

From: Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study)

  Enrolment Start 3 months 6 months 9 months 12 months 24 months 36 months +12 months
Visit SE V0 V1 V1–6 V1–9 V2 V3 V4 Follow-up
Enrolment
 Eligibility screen X         
 Informed consent X         
 Randomisation X         
Interventions
 Intervention group (I) X X X X X X X X X
 Control group (C) X X     X X X X
Assessments
 Clinical baseline C + I         
 Clinical follow up       C + I C + I C + I C + I
 Spiroergometry C + I   C + I    C + I    
 Accelerometry C + I   C + I C + I C + I C + I    
 Questionnaire “training” (IPAQ-L)   C + I C + I C + I C + I C + I C + I C + I  
 Questionnaire “nutrition” (MEDAS, EPIC-FFQ) C + I   C + I I I C + I C + I C + I  
 Lab C + I   C + I    C + I C + I C + I  
 Clinical examination C + I   C + I    C + I C + I C + I  
 Anthropometry C + I   C + I    C + I C + I C + I  
 Psychological questionnaires C + I   C + I    C + I C + I C + I