Methods
This RCT was approved by the institutional review board at the University of Texas Health Science Center at San Antonio. Participants provided written informed consent, completed a baseline screening to determine eligibility, and were randomly assigned to treatment condition by the project biostatistician using an SAS random allocation sequence program version 9.3 (SAS Institute) with block sizes of 2, 4, and 6. This report follows the Consolidated Standards of Reporting Trials (