Lifestyle Intervention Achieves Increased Reduction in A1C After Six Months for African Americans with Type 2 Diabetes

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Jun 12, 2016, 05:45 ET

NEW ORLEANS, June 12, 2016 /PRNewswire-USNewswire/ -- A study designed to test the impact of an intensive lifestyle intervention program on lowering blood glucose levels in low-income, African Americans with type 2 diabetes successfully reduced A1C after six months, relative to standard-of-care diabetes education. However, the study found no significant difference in reductions in the two groups by the end of the study period of one year, according to results reported at the American Diabetes Association's 76th Scientific Sessions^®, June 12, 2016, at the Ernest N. Morial Convention Center in New Orleans.

African Americans with type 2 diabetes suffer disproportionate rates of diabetes complications and hospitalizations, mostly due to poor glycemic control. This study evaluated if an intensive lifestyle intervention for low-income African Americans could help reduce blood glucose levels through a culturally-tailored and interactive intensive diabetes education program and increased social support that would lead to changes in diet and physical activity.

The study included 211 low-income, African American patients (55±10 years of age) with uncontrolled type 2 diabetes (A1C>7%) attending five outpatient clinics in the Cook County Health and Hospitals System (CCHHS) in Chicago. Participants were 70 percent female and 58 percent had an income of ≤$20,000 per year. They were randomly assigned to an intensive diabetes self-management arm known as the Lifestyle Improvement through Food and Exercise (LIFE) program (n=106), or a control arm (n=105) that received standard of care diabetes education. Participants had BMI of 35.6±8 kg/m2 and a duration of diabetes of 11.3±9 years. Participant retention was 93 percent in the LIFE arm and 95 percent in the control arm.

Patients in the LIFE arm were offered 28 group counseling sessions with dietitians and peer supporters in a community setting during the study period of one year, meeting weekly for the first four months; biweekly for the second four months; and monthly for the last four months of the study. The group sessions consisted of interactive and culturally-tailored diabetes nutrition education; group exercise sessions; and social support in the form of supportive group discussions and problem solving assistance. The LIFE arm patients also received weekly phone calls from peer supporters in their community during the same 12-month period. Participants were educated and counseled to be able to self-monitor blood glucose levels and to interpret the levels in order to actively participate in their diabetes management. .

Patients in the control group participated in two diabetes self-management education group classes, led by a registered dietitian in the first six months of the study. While this level of education meets national standards, it is not usual care for diabetes patients in the Cook County Health and Hospitals System.

At six months, patients in the LIFE arm had a significantly greater reduction of A1C (-0.76 vs. -0.21 in control, p=0.026), as well as a higher percentage of participants who saw a decline of more than 0.5 percent in their average blood glucose levels (63 percent in the LIFE group vs. 42 percent in the control group, p=0.005). These differences, however, were not maintained at 12 months. By the end of the 12-month study period, patients in the control group also exhibited a decrease in A1C (-0.63 for the LIFE group vs. -0.45 for the control, p=0.47), and an equal number of patients in each group achieved a reduction in A1C of more than 0.5 percent compared to those in the LIFE arm (53 percent in the LIFE group vs. 51 percent in the control group, p=0.89). A greater number of participants in the LIFE group achieved glycemic control at 12 months (61 percent in the LIFE group vs. 39 percent in the control group, p=0.16) but that difference was not statistically significant.

"Sustained behavior change is very difficult and may be especially difficult for low-income, high-risk patients with type 2 diabetes," said lead investigator Elizabeth B. Lynch, PhD, Associate Professor, Department of Preventive Medicine, Rush University Medical Center, Chicago. "While our results confirm positive results in a high-risk population with intensive educational and social support, they also suggest that, over time, motivated patients take the initiative and achieve glycemic control with standard-of-care education."

"One possible explanation for the decrease in A1C in the control group is that medication adherence increased in this group, relative to the intervention group," explained Lynch. "Additional research is needed to identify the most effective strategies to achieve sustained A1C control in African Americans with type 2 diabetes."

The American Diabetes Association's 76th Scientific Sessions, to be held June 10-14, 2016, at the Ernest N. Morial Convention Center in New Orleans, is the world's largest scientific meeting focused on diabetes. The 2016 Scientific Sessions is expected to attract more than 16,000 attendees and offers researchers and health care professionals from around the world the opportunity to share ideas and learn about the significant advances in diabetes research, treatment and care. During the five-day meeting, attendees receive exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight theme areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Margaret A. Powers, PhD, RD, CDE, President, Health Care & Education, will deliver her address on Saturday, June 11, and Desmond Schatz, MD, President, Medicine & Science, will present his address on Sunday, June 12. The top eight abstracts of this year's Scientific Sessions will be presented on Tuesday, June 14, in the Presidents Oral Session. In total, the 2016 Scientific Sessions includes 378 abstracts in 50 oral sessions, 2,021 poster presentations including 59 moderated poster discussions, and 335 published-only abstracts. The Association's 2016 Scientific Achievement Awards and Lectures are:

Barbara B. Kahn, MD, Banting Medal for Scientific Achievement, the Association's highest honor. Kahn will deliver the Banting Medal Lecture, "Adipose Tissue, Inter-organ Communication, and the Path to T2D," on Sunday, June 12.
Tamas L. Horvath, DVM, PhD, Outstanding Scientific Achievement Award (OSAA), will present his OSAA Lecture, "Hunger-promoting Hypothalamic Neurons Control System Metabolism and Drive Complex Behaviors and Longevity," on Monday, June 13.
Sheri R. Colberg-Ochs, PhD, FACSM, Outstanding Diabetes Educator, will present her Lecture, "From Froot Loops^® to Fitness—My Journey as an Educator and PWD," on Saturday, June 11.
Edward W. Gregg, PhD, Kelly West Award for Outstanding Achievement in Epidemiology, will deliver his Lecture, "The Changing Tides of the Diabetes Epidemic—Smooth Sailing or Troubled Waters Ahead?," on Sunday, June 12.

Additional scientific research will be presented during 110 Symposia and nine Professional Interest Group sessions. The 76th Scientific Sessions also includes presence from more than 130 corporate and organizational exhibitors in nearly 100,000 square feet of exhibit space. Join the Scientific Sessions conversation on Twitter, #2016ADA.

About the American Diabetes Association
The American Diabetes Association is leading the fight to Stop Diabetes^® and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, the Association's mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

76th Scientific Sessions
News Briefing: Diabetes Prevention and Improved Management, Monday, June 13, 10:30 a.m. CT

Oral Presentation: Diversifying Our Portfolio of Self-Management Intervention Approaches
Location: Room 355
Session Time: Sunday, June 12, 2016, 4:30 p.m.–6:30 p.m.

282–OR

Lifestyle Improvement through Food and Exercise (LIFE): Randomized Trial of a Self-Management Intervention for Underserved African Americans with Type 2 Diabetes

ELIZABETH B. LYNCH, LAURIN MACK, ELIZABETH AVERY, KATHRYN S. KEIM, BRADLEY APPELHANS, REBECCA LIEBMAN, JENNIFER VENTRELLE, BETTINA TAHSIN, YAMIN WANG, BHARAT RAJAN, LEON FOGELFELD, Chicago, IL

African Americans experience increased morbidity and mortality from type 2 diabetes (T2DM). Prior diabetes self-management programs have failed to demonstrate long-term efficacy in this population. This RCT compared an intensive, diabetes self-management training program (the LIFE Program) to standard of care diabetes education on change in glycemic control (A1C) over 12 months. The LIFE program consisted of 20 group sessions in the first 6 months and 8 sessions in the second 6 months. Sessions featured culturally-tailored nutrition education taught by a registered dietitian, group exercise and supportive group discussion and problem-solving. Participants also received regular telephone support from a peer educator. The control group received two group-based diabetes education classes. African Americans (N=211) with A1C ≥ 7.0 were recruited from 5 Cook County safety net clinics, and randomized to the LIFE intervention (n=105) or control (n=106). Retention was 94%. Participants averaged 55±10 years of age, 58% had income < $20K, and 70% were female. Baseline A1C was 9.0±1.7, BMI was 35.6±8 kg/m2, duration of diabetes was 11.3±9 years, and 45% were treated with insulin. The intervention group had a significantly greater reduction in A1C at 6-months (-0.76 vs -0.21 in control, p=0.026), but not at 12-months (-0.63 vs -0.45, p=0.47). There was also a significantly higher percentage of intervention vs control participants who had a 0.5% or more decline in A1C at 6 months (63 vs 42%, p=0.005) but not at one year (53 vs 51%, p=0.89). This study shows significant A1C improvement in the intervention group at 6 months. The lack of a treatment effect at 12 months may be due to a difference in treatment intensity between the first and second study periods and improvement in control A1C. More investigation is needed to identify intervention components that will result in sustained A1C reduction in African AmericanT2DM patients.

Author Disclosure Block:

E.B. Lynch: None. L. Mack: None. E. Avery: None. K.S. Keim: None. B. Appelhans: None. R. Liebman: None. J. Ventrelle: None. B. Tahsin: None. Y. Wang: None. B. Rajan: None. L. Fogelfeld: None.