Potential participants called a toll-free number to
undergo eligibility screening. Those deemed eligible
attended an orientation session to learn more about the
study and, if interested in enrolling, followed informed
consent procedures and completed a baseline assessment
that included a blood sample, blood pressure
(BP), height, weight, body mass index (BMI), waist
circumference measurements, and a self-report survey.
Participants were then randomized to 1 of 2 arms: a
3-month DSME program followed by 12 months of
peer-led DSMS; or a 3-month DSME program alone.
Random sequence generation and group assignment
were determined centrally just prior to the initial
session. Participants and staff were blinded to randomization
results until completion of baseline assessment.
Data assessors remained blinded to group assignment
throughout the study. Participants received a stipend
of $40 upon completion of each of the 4 assessments—
baseline, 3-month, 9-month, and 15-month.