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Two-year weight-loss maintenance in primary care-based Diabetes Prevention Program lifestyle interventions
Xiao L, Yank V, Wilson SR, Lavori PW, Ma J
Nutrition & Diabetes 2013 Jun;3(6):e76
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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: To investigate whether the effects on weight loss and cardiometabolic risk factor reduction of two technology-mediated lifestyle interventions for 15 months in a primary care-based translation trial sustained at 24 months (that is, 9 months after the end of intervention). DESIGN: This study analyzed data from an extended follow-up of participants in the original 'E-LITE' (Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care) randomized controlled trial, which demonstrated the effectiveness of two adapted Diabetes Prevention Program (DPP) lifestyle interventions compared with usual primary care. SUBJECTS: E-LITE randomized 241 overweight or obese participants with pre-diabetes and/or metabolic syndrome to receive usual care alone (n = 81) or usual care plus a coach-led (n = 79) or self-directed intervention (n = 81). The interventions provided coach-led group behavioral weight-loss treatment or a take-home, self-directed DVD using the same 12-week curriculum, followed by 12 additional months of technology-mediated coach contact and self-monitoring support. Participants received no further intervention after month 15. A blinded assessor conducted 24-month visits by following the measurement protocols of the original trial. Measurements include weight and cardiometabolic risk factors (waist circumference, fasting plasma glucose, resting blood pressure, triglycerides, high- and low-density lipoprotein cholesterol, total cholesterol and triglyceride to high-density lipoprotein cholesterol ratio). RESULTS: At month 24, mean +/- se changes in body mass index (trial primary outcome) and weight (kg) from baseline were -1.9 +/- 0.3 (p = 0.001) and -5.4 +/- 0.9 (p < 0.001) in the coach-led intervention, and -1.6 +/- 0.3 (p = 0.03) and -4.5 +/- 0.9 (p = 0.001) in the self-directed intervention, compared with -0.9 +/- 0.3 and 2.4 +/- 0.9 in the usual care group. In addition, both interventions led to a greater percentage of participants maintaining >= 7% weight loss and sustained improvements in waist circumference and fasting plasma glucose levels than usual care. CONCLUSION: This study shows sustained benefits of the two primary care-based, technology-mediated DPP lifestyle interventions. The findings warrant replication in long-term studies involving diverse populations.

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