OBJECTIVE: To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: The study consisted of a 12-month randomized controlled trial of 147 health plan members with type 2 diabetes and obesity (BMI >or=27 kg/m(2)). Participants were randomized to lifestyle case management or usual care. Case management entailed individual and group education, support, and referral by registered dietitians; intervention cost was US dollars 350 per person. Individuals treated with usual care received educational material. Both groups received ongoing primary care. Outcomes were difference between groups for change in weight (kilograms), waist circumference (centimeters), HbA(1c), fasting lipid levels, use of prescription medications, and health-related quality of life. RESULTS: Case management resulted in greater weight loss (P < 0.001), reduced waist circumference (P < 0.001), reduced HbA(1c) level (P = 0.02), less use of prescription medications (P = 0.03), and improved health-related quality of life (P < 0.001) compared with usual care. The 12-month group difference in weight loss and waist circumference was 3.0 kg (95% CI -5.4 to -0.6) and -4.2 cm (-6.8 to -1.6). HbA(1c) differences were greatest at 4 months (-0.59%, P = 0.006) but not significant by 12 months (-0.19%, P = 0.45). Participants in the case management group lowered their use of medications, primarily diabetes medications, by 0.8 medications per day more than participants treated with usual care (P = 0.03). In seven of nine quality-of-life domains, the case management group improved compared with usual care (P < 0.05). CONCLUSIONS: Moderate-cost dietitian-led lifestyle case management may improve diverse health indicators among obese patients with type 2 diabetes.
RCT Entities:
OBJECTIVE: To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obesepatients with type 2 diabetes. RESEARCH DESIGN AND METHODS: The study consisted of a 12-month randomized controlled trial of 147 health plan members with type 2 diabetes and obesity (BMI >or=27 kg/m(2)). Participants were randomized to lifestyle case management or usual care. Case management entailed individual and group education, support, and referral by registered dietitians; intervention cost was US dollars 350 per person. Individuals treated with usual care received educational material. Both groups received ongoing primary care. Outcomes were difference between groups for change in weight (kilograms), waist circumference (centimeters), HbA(1c), fasting lipid levels, use of prescription medications, and health-related quality of life. RESULTS: Case management resulted in greater weight loss (P < 0.001), reduced waist circumference (P < 0.001), reduced HbA(1c) level (P = 0.02), less use of prescription medications (P = 0.03), and improved health-related quality of life (P < 0.001) compared with usual care. The 12-month group difference in weight loss and waist circumference was 3.0 kg (95% CI -5.4 to -0.6) and -4.2 cm (-6.8 to -1.6). HbA(1c) differences were greatest at 4 months (-0.59%, P = 0.006) but not significant by 12 months (-0.19%, P = 0.45). Participants in the case management group lowered their use of medications, primarily diabetes medications, by 0.8 medications per day more than participants treated with usual care (P = 0.03). In seven of nine quality-of-life domains, the case management group improved compared with usual care (P < 0.05). CONCLUSIONS: Moderate-cost dietitian-led lifestyle case management may improve diverse health indicators among obesepatients with type 2 diabetes.
Authors: Michael D Jensen; Donna H Ryan; Caroline M Apovian; Jamy D Ard; Anthony G Comuzzie; Karen A Donato; Frank B Hu; Van S Hubbard; John M Jakicic; Robert F Kushner; Catherine M Loria; Barbara E Millen; Cathy A Nonas; F Xavier Pi-Sunyer; June Stevens; Victor J Stevens; Thomas A Wadden; Bruce M Wolfe; Susan Z Yanovski; Harmon S Jordan; Karima A Kendall; Linda J Lux; Roycelynn Mentor-Marcel; Laura C Morgan; Michael G Trisolini; Janusz Wnek; Jeffrey L Anderson; Jonathan L Halperin; Nancy M Albert; Biykem Bozkurt; Ralph G Brindis; Lesley H Curtis; David DeMets; Judith S Hochman; Richard J Kovacs; E Magnus Ohman; Susan J Pressler; Frank W Sellke; Win-Kuang Shen; Sidney C Smith; Gordon F Tomaselli Journal: Circulation Date: 2013-11-12 Impact factor: 29.690
Authors: Sheri J Hartman; Patricia M Risica; Kim M Gans; Bess H Marcus; Charles B Eaton Journal: Contemp Clin Trials Date: 2014-06-15 Impact factor: 2.226