Volume 11 — May 29, 2014
ORIGINAL RESEARCH
A Self-Management Intervention for African Americans With Comorbid Diabetes and Hypertension: A Pilot Randomized Controlled Trial
This diagram outlines the 4 stages of the study: enrollment, allocation, follow-up, and analysis. During enrollment, 183 people were assessed for eligibility; of these, 122 people were excluded for the following reasons: 40 did not have diabetes or did not take diabetes medications; 17 did not have hypertension or did not take hypertension medication; 13 had a body mass index that was out of range; 21 were excluded for other reasons (eg, pregnant, heart failure); and 31 refused to participate (eg, could not attend group sessions, did not return calls). Sixty-one people were randomized. During allocation, 30 were allocated to the intervention, and 31 were allocated to the control group. Of those allocated to the intervention, 21 people received the intervention (they attended 9 or more of 18 classes), and 9 did not receive the intervention (they attended fewer than 9 of 18 classes). Of the 31 allocated to the control group, 23 received the intervention (they attended at least 1 of the 2 classes), and 8 did not receive the intervention (they attended no classes). Four people in the intervention were lost to follow-up (they moved out of state or they did not return calls); none of the intervention participants discontinued the intervention. In the control group, 2 participants were lost to follow-up (they did not return calls), and none discontinued the intervention. During analysis, 26 intervention participants and 29 control participants were analyzed; none were excluded from analysis.
Figure. Recruitment, screening, and participation in LIFE intervention, Chicago, Illinois, 2009–2010.
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