BACKGROUND: The efficacy of physical activity with a healthful diet to reduce obesity is established; however, little is known about the translation of effective lifestyle strategies for obesity reduction in primary care settings. METHODS: We assessed the effectiveness of a 2-year behaviorally based physical activity and diet program implemented entirely within clinical practices to reduce obesity. A total of 490 sedentary, obese adults were randomized to usual care (n = 241) or to the behavioral intervention (n = 249). The usual care group received advice from their physicians about lifestyle as a strategy for obesity reduction. The behavioral intervention included individual counseling from health educators to promote physical activity with a healthful diet. The primary outcome was change in waist circumference (WC). RESULTS: A total of 396 participants completed the trial (80.8%). A significant main effect was observed for WC change within the intervention compared with usual care (p < 0.001) that was sustained at 24 months (mean (SE) -0.9 (0.4) versus 0.2 (0.4) cm; p = 0.05). Secondary analyses revealed significant main effects for change in WC in men (p = 0.009) and women (p = 0.02). In men, the mean (SE) reduction in WC at 24 months was greater with behavioral intervention compared with usual care (-1.6 (0.6) versus 0.1 (0.6) cm; p = 0.049). In women, the behavioral intervention was associated with differences in WC compared with usual care at 6 and 12 months (p <= 0.01) but not at 24 months (p = 0.10). CONCLUSIONS: Behavioral intervention in clinical settings is associated with modest reductions in WC during a 2-year study in obese patients. However, the effectiveness of the intervention is restricted to men. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00665158.

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