Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes
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.
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 (β = − 0.026, p = 0.003) and the comparison arm (β = − 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.
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.
NIH Trial Registry Number
KEY WORDSdiabetes self-management randomized trials disparities
Joellen Wilbur, PhD, and Don Waddell, MA, provided assistance with an early phase of this project. Tangula Jefferson, Candace Nicks, and Syed Quadri provided assistance with data collection. Wil Mims and Denise Mason served as peer supporters. Don Waddell, Francine Stark, Sheila Reed, and LaDawne Jenkins served as group facilitators. Jadwiga Miernik, MD, and Rajeev Mehrotra, MD, directed the patient screening for recruitment.
E.B.L., principal investigator, developed the study concept, directed study operations, drafted the manuscript, integrated coauthor comments and edits, and is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. L.M. provided clinical supervision of study interventionists, led study operations, and contributed to the manuscript, particularly the methods section and tables. R.D. assisted with development of the intervention and served as project director, D.R. contributed to study design and supervised statistical analysis, and E.A. led data management and contributed to statistical analysis and study design. Y.W. conducted most statistical analyses, wrote the statistics section, and contributed to the RESULTS section. K.K. contributed to intervention design and supervised dietary data collection and performed quality control on dietary data, J.V. contributed to development and implementation of the intervention, B.A. provided clinical supervision of study interventionists and contributed to study design and editing the manuscript, B.T. assisted with study design and delivery of the intervention, and L.F. contributed to study design, manuscript and provided medical supervision for the study. Use of the ©MMAS is protected by US copyright laws. Permission for use is required. A license agreement is available from Donald E. Morisky, MMAS Research, LLC 14725 NE 20th St., Bellevue, WA, 98007.
This research was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number R01DK092271 and the National Institute for Heart Lung and Blood (NHLBI), grant number 1P50HL105189-01.
Compliance with Ethical Standards
The study was approved by the Rush University Medical Center and Cook County Health and Hospitals System (CCHHS) Institutional Review Boards. All participants gave written informed consent.
Conflict of Interest
The authors declare that they do not have a conflict of interest.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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