Abstract
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.