BACKGROUND: Most Americans do not meet diet and physical activity recommendations despite known health benefits. PURPOSE: To systematically review the benefits and harms of lifestyle counseling interventions in persons with cardiovascular risk factors for the US Preventive Services Task Force. DATA SOURCES: Medline, PsycINFO, the Database of Abstracts of Reviews of Effects, and the Cochrane Central Register of Controlled Trials (January 2001 to October 2013); experts; and existing systematic reviews. STUDY SELECTION: Two investigators independently reviewed 7218 abstracts and 553 articles against a set of inclusion and quality criteria. DATA EXTRACTION: Data from 74 trials were abstracted by one reviewer and checked by a second. DATA SYNTHESIS: At 12 to 24 months, intensive lifestyle counseling in persons selected for risk factors reduced total cholesterol levels by an average of 0.12 mmol/L (95% CI 0.16 to 0.07 mmol/L) (4.48 mg/dL (CI 6.36 to 2.59 mg/dL)), low-density lipoprotein cholesterol levels by 0.09 mmol/L (CI 0.14 to 0.04 mmol/L) (3.43 mg/dL (CI 5.37 to 1.49 mg/dL)), systolic blood pressure by 2.03 mmHg (CI 2.91 to 1.15 mmHg), diastolic blood pressure by 1.38 mmHg (CI 1.92 to 0.83 mmHg), fasting glucose levels by 0.12 mmol/L (CI 0.18 to 0.05 mmol/L) (2.08 mg/dL (CI 3.29 to 0.88 mg/dL)), diabetes incidence by a relative risk of 0.58 (CI 0.37 to 0.89), and weight outcomes by a standardized mean difference of 0.25 (CI 0.35 to 0.16). Behavioral changes in dietary intake and physical activity were generally concordant with changes in physiologic outcomes. LIMITATION: Sparse reporting of patient health outcomes, longer-term follow-up of outcomes, and harms. CONCLUSION: Intensive diet and physical activity behavioral counseling in persons with risk factors for cardiovascular disease resulted in consistent improvements across various important intermediate health outcomes up to 2 years. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

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