Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes

BACKGROUND: African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS: This randomized controlled trial (n=211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS: At 6 months, A1c decreased significantly more in the intervention group than the control group (-0.76 vs -0.21%, p=0.03). However, by 12 and 18 months, the difference was no longer significant (12 months -0.63 intervention vs -0.45 control, p=0.52). There was a decrease in A1c over 18 months in both the intervention (beta=-0.026, p=0.003) and the comparison arm (beta=-0.018, p=0.048) but no difference in trend (p=0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p=0.002) and diet quality (4.0 vs -0.5 point change, p=0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p<0.05) at 12 months. CONCLUSIONS: The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.