OBJECTIVES: To assess the ability of a 12-week primary care-based intensive lifestyle intervention (ILI), to facilitate a 5% reduction in baseline weight compared with an education-only active comparator (AC). METHODS: A randomized clinical trial was conducted in a primary health care setting in Jeddah, Saudi Arabia between December 2014 and June 2015. Arab participants with obesity, but who were otherwise healthy (n = 140), were randomized to the ILI (n = 70) or AC (n = 70) group. The ILI group received 8 clinical visits throughout the study. The AC group received only an initial health education session. The primary outcome was the proportion of participants who achieved clinically significant weight loss (>= 5% of their baseline weight). RESULTS: Participants in the ILI group were significantly more likely than those in the AC group to achieve the primary outcome (p = 0.008, relative risk: 1.8 (95% confidence interval (CI) 1.15 to 2.93). At week 12, the ILI group exhibited a mean weight decrease of 5.58 +/- 5.60 kg (-5.37 +/- 5.31%), significantly greater than that observed in the AC group (-2.8 +/- 4.96 kg, -2.62 +/- 4.34%, p = 0.002), and corresponding to a weight loss advantage of 2.77 kg (95% CI 1.01 to 4.54 kg) or 2.75% (95% CI 1.13% to 4.37%). CONCLUSION: The 12-week primary care-based ILI program was effective in achieving a clinically meaningful weight reduction (>= 5%) among Saudi and Arab patients with obesity.

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