OBJECTIVE:To evaluate the effectiveness of a culturally appropriate lifestyle intervention combined with orlistat in producing weight loss with obese Mexican-American women. SUBJECTS: Mexican-American women (N ¼ 108), aged 21-65 y, with a body mass index (BMI) Z27 kg/m 2 were randomized to 1 y of treatment with orlistat and a culturally tailored lifestyle modification intervention (OLM; n ¼ 56) or a wait-list control group (WLC; n ¼ 52). DESIGN: A randomized, controlled, open-label 12-month study. Orlistat was dosed at 120 mg, three times per day. The OLM intervention included behavior modification, a low-fat (r30% of total daily calories) diet, and moderate physical activity (Z150 min/week). MEASUREMENT: Primary outcomes included changes in body weight (kg), BMI, waist circumference, blood pressure, glucose, and lipids. RESULTS: A total of 72 (37 OLM, 35 WLC) and 66 participants (32 OLM, 34 WLC) completed the 6-and 12-month follow-ups, respectively. Repeated-measures ANOVA demonstrated a significant time  treatment interaction (Wilks' l ¼ 12.61; Po0.001), indicating that OLM-treated patients achieved significant weight loss relative to the WLC group during the study (mean percentage weight loss7s.e.m.; À8.1%71.2 vs À1.6%70.7 at 6 months and À8.8%71.5 vs À0.2%71.0 at 12 months, respectively). OLM-treated patients also experienced significant reductions in waist circumference, low-density-lipoprotein, and total cholesterol. CONCLUSIONS: This study demonstrates the effectiveness of an intervention combining orlistat and lifestyle modification with Mexican-American women, a population with substantial risk for obesity. International Journal of Obesity (2003) 27, 1486-1493. doi:10.1038/sj.ijo.0802439Keywords: Mexican American; women; orlistat; culturally appropriate Mexican Americans in the United States are at increased risk for overweight and obesity and tend to develop obesity at an earlier age than non-Hispanics. 1-4 Currently, among Mexican-American women and men, the prevalence of overweight or obesity (body mass index (BMI) Z25 kg/m 2 ) is 71.9 and 74.7%, respectively. 5 The prevalence of abdominal obesity (ie, waist circumference 488 cm for women and 4102 cm for men) is 62.7% for Mexican-American women and 30.6% for Mexican-American men. 6 Mexican Americans are also predisposed to develop more atherogenic patterns of body fat distribution. 7,8 Early weight gain and centralized and upper body fat have been associated with the onset of diabetes in Mexican Americans. 9 For example, Mexican Americans with centralized obesity are at significantly greater risk for low HDL-C, high total cholesterol, and high blood glucose than nonobese individuals or those with nonabdominal obesity. 8 In addition, 50% of Mexican-American adults 35 y or older either have diabetes themselves or have a first-degree relative with diabetes. 10 Modest weight loss can have a beneficial effect on cardiovascular disease and diabetes risk factors. 1,[11][12][13][14] It is likely that Mexican Americans, and other minority groups, would also ...