Volume 11 — February 27, 2014
Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial
The number of people who received spot blood glucose tests was 5,820. Of these, 4,789 had normal blood glucose levels and were ineligible for participation. The remaining 1,031 were eligible for hemoglobin A1c testing (HbA1c). After testing, 601 people were excluded for the following reasons: HbA1c test results were normal (n = 189), the participant was lost to follow-up (n = 268), the participant declined to participate (n = 121), and other reasons (n = 23). The number randomly assigned to the trial arms was 430. Of these, 219 were assigned to the immediate intervention arm and 211 to the delayed intervention arm. A total of 53 people assigned to the immediate intervention were excluded for the following reasons: refused (n = 28), moved (n = 3), lost to follow-up (n = 18), ineligible (n = 3), missing data (n = 1). From the group assigned to the delayed intervention, 57 were excluded for the following reasons: refused (n = 22), moved (n = 12), lost to follow-up (n = 15), ineligible (n = 2), missing data (n = 6). One hundred and sixty-six participants in the immediate intervention and 154 in the delayed intervention were available for the efficacy evaluable analysis. Participants who were late giving a blood sample (55 in the immediate arm and 37 in the delayed arm) were excluded as part of a sensitivity analysis. The sensitivity analysis was conducted on data from 111 people in the immediate intervention and 117 in the delayed intervention arm.
Figure 1. Overview of the process for the randomized-controlled prevention trial of the Partnership for a Hispanic Diabetes Prevention Program. Abbreviation: HbA1c, hemoglobin A1c.
This flowchart shows how and when trial participants entered the trial and received the intervention. After completing the baseline survey and having HbA1c tested, recruits were randomly assigned into 2 groups; one received the immediate intervention and one received the delayed intervention. Both groups had a second HbA1c test at 3 months postrandomization. Participants in the delayed intervention group began receiving the intervention at the trial’s 3-month time point. All participants completed a final survey and had a final HbA1c test at the 6-month time-point.
Figure 2. Timing of intervention and HbA1c measurements. Abbreviation: HbA1c, hemoglobin A1c.
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