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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