Cost Results from Look AHEAD Study

San Diego—The annual costs associated with managing patients with type 2 diabetes through a structured lifestyle intervention decreased during a 4-year period, according to results of an ongoing multicenter, randomized controlled trial. Ping Zhang, PhD, from the Centers for Disease Control and Prevention’s Division of Diabetes Translation, presented the findings at the ADA meeting in an oral abstract session. The Look AHEAD (Action for Health in Diabetes) study enrolled 5145 overweight patients with type 2 diabetes and randomly assigned them in a 1:1 ratio to an intensive lifestyle intervention program (n=2570) or a control group that received a diabetes support and education program (n=2575). Patients will be followed for up to 13.5 years. The study is sponsored by the Department of Health and Human Services and the National Institute of Diabetes and Digestive and Kidney Diseases. The trial is focused on examining the long-term effects of decreasing caloric intake and increasing physical activity on cardiovascular morbidity and mortality. Patients were included in the study if they were between 45 and 76 years of age, had a body mass index (BMI) ≥25 kg/m2 or ≥27 kg/m2 if they were on insulin, had a hemoglobin A1c level ≤11%, had a blood pressure reading ≤160/100 mm Hg, and a triglyceride level ≤600 mg/dL. The 2 groups had similar baseline characteristics. There were approximately 60% males and 37% minorities, the average age was approximately 59 years, the average BMI was approximately 36.0 mm Hg, approximately 15% were insulin users, and approximately 15% had a history of cardiovascular disease. Dr. Zhang said structured lifestyle interventions have proven effective for preventing and managing type 2 diabetes. In this trial, the researchers were hoping to see a 7% weight loss for the lifestyle intervention group, while individuals had a goal to lose 10% of their body weight. People were instructed to spend 175 minutes per week on moderate intensity activity. During the first 6 months, patients in the lifestyle intervention group had weekly meetings (3 group meetings and 1 individual meeting per month). From months 7 through 12, patients had 2 group sessions and 1 individual session per month. In years 2, 3, and 4, they had a monthly individual counseling session as well as refresher courses or campaigns 2 or 3 times per year. Patients who received diabetes support education had 3 to 4 meetings per year on topics such as diet, exercise, and social support. The authors estimated the average clinic-specific personnel cost of a patient visit and had the study’s staff complete questionnaires detailing the types of personnel and time involved in individual and group sessions. They excluded research costs. Each site also reported the salaries and benefits associated with each type of worker. In year 1, the average cost per participant in the lifestyle intervention group was $3175. The cost decreased to $1760 per participant in year 2, $1214 per participant in year 3, and $1176 per participant in year 4. Meanwhile, the average cost per participant in the diabetes support education group was $83 in the first year, $64 in the second year, $65 in the third year, and $72 in the fourth year. Dr. Zhang said the data presented at the ADA meeting will be combined with other cost data, such as laboratory tests, food, and exercise, to determine the cost-effectiveness of implementing the lifestyle intervention program. Dr. Zhang said the following companies were major study donors: Abbott Nutrition, FedEx Corp, Health Management Resources, Hoffmann-La Roche, Inc, LifeScan, Inc, Nestle HealthCare Nutrition, Inc, and Unilever.