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Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial
The Look AHEAD Research Group
Archives of Internal Medicine 2010 Sep 27;170(17):1566-1575
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; 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: Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS: The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5,145 overweight or obese individuals (59.5% female; mean age 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS: Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% versus -0.88%; p < 0.001) and greater improvements in treadmill fitness (12.74% versus 1.96%; p < 0.001), hemoglobin A1c level (-0.36% versus -0.09%; p < 0.001), systolic (-5.33 versus -2.97 mmHg; p < 0.001) and diastolic (-2.92 versus -2.48 mmHg; p = 0.01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 versus 1.97 mg/dL; p < 0.001) and triglycerides (-25.56 versus -19.75 mg/dL; p < 0.001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 versus -12.84 mg/dL; p = 0.009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A1c levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS: Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial.

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