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A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program
Foster GD, Wadden TA, la Grotte CA, Vander Veur SS, Hesson LA, Homko CJ, Maschak-Carey BJ, Barbor NR, Bailer B, Diewald L, Komaroff E, Herring SJ, Vetter ML
Nutrition & Diabetes 2013 Mar;3(3):e63
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: One-hundred participants with a mean +/- SD age of 55.6 +/- 10.6 year, body weight of 102.9 +/- 18.4kg and HbA1c of 7.7 +/- 1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1,250 to 1,550kcal per day) and physical activity (200min per week). RESULTS: While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3kg (95% confidence interval (CI) -5.8 to -8.8kg), compared with 2.2kg (95% CI -0.7 to -3.7kg) in the DSME group (p < 0.0001). Significantly more PCD than DSME participants lost 5% of initial weight (54.0% versus 14.0%, p < 0.0001) and 10% (26.0% versus 6.0%, p < 0.0001). HbA1c declined by 0.7% (95% CI -0.4 to -1.0%) in the PCD group, compared with 0.4% (95% CI -0.1 to -0.7%) in DSME (p < 0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r = 0.52, p < 0.0001). CONCLUSIONS: These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

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