Randomization and Blinding
Once the questionnaire and initial measurements were completed,
participants were randomized to either a control arm, HBPM alone or HBPM
plus HH4NM intervention in a 1:1:1 allocation. We utilized a block
randomization schema with block sizes of six generated by a blinded
statistician using the procedure PLAN in the statistical software
package SAS (SAS Institute, Inc., Cary, NC). Study staff and study
physicians and investigators interacting with prospective participants
during recruitment were blinded to which arm a participant would be
randomized. Study staff, who conducted the study visits and instructed
participants on study protocols were unblinded at the time of
randomization. Study physicians, investigators and the statistician
remained blinded until completion of all study visits.