Participants will be randomly assigned at 1:1 ratio to an intervention (I) or a control (C) group after consenting and baseline assessment (see figure 1). Block randomisation (blocks of 10) will be used. An independent individual will generate a computer-generated random sequence of grouping identifiers (I or C). According to the sequence, the individual will place a grouping identifier into the opaque, identical, sealed and sequentially numbered envelopes. An independent mediator, who is not involved in recruitment, assessment or delivery of FBB, will store these envelopes in an undisclosed location, open the envelopes sequentially according to the participants’ time of enrolment, record and inform the principal investigator about the participants’ group allocations.

Flow of participants in the study.

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