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Six-month outcomes from living well with diabetes: a randomized trial of a telephone-delivered weight loss and physical activity intervention to improve glycemic control
Eakin EG, Reeves MM, Winkler E, Healy GN, Dunstan DW, Owen N, Marshal AM, Wilkie KC
Annals of Behavioral Medicine 2013 Oct;46(2):193-203
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; 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*

BACKGROUND: Intensive lifestyle intervention trials in type 2 diabetes contribute evidence on what can be achieved under optimal conditions, but are less informative for translation in applied settings. PURPOSE: Living well with diabetes is a telephone-delivered weight loss intervention designed for real-world delivery. METHODS: This study is a randomized controlled trial of telephone counseling (n = 151) versus usual care (n = 151); 6-month primary outcomes of weight, physical activity, HbA1c; secondary diet outcomes; analysis was by adjusted generalized linear models. RESULTS: Relative to usual care, telephone counseling participants had small but significantly better weight loss (-1.12% of initial body weight; 95% confidence interval (CI) -1.92 to -0.33%); physical activity (relative rate (RR) 1.30; 95% CI 1.08 to 1.57); energy intake reduction (-0.63 MJ/day; 95% CI -1.01 to -0.25); and diet quality (3.72 points; 95% CI 1.77 to 5.68), with no intervention effect for HbA1c (RR 0.99; 95% CI 0.96 to 1.01). CONCLUSIONS: Results are discussed in light of challenges to intervention delivery.

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