BACKGROUND: Few randomized controlled trials on lifestyle interventions have been reported in non-Western populations; none have been reported in Arab populations. METHODS:From 2 Muslim Arab communities in Israel, obese, nondiabetic women aged 35 to 54 years with 1 or more components of the metabolic syndrome were randomized to either an intensive (n = 100) or a moderate (control) (n = 101) 12-month lifestyle intervention. Women in the intensive intervention had 11 individual and 11 group counseling sessions per year with a dietitian and 22 physical activity group sessions per year. Women in the moderate intervention had 3 individual and 2 group dietary counseling sessions per year and no guided physical activity. Cultural issues were addressed in the design and conduct of both interventions. The primary outcome measure was change in the metabolic syndrome and its components. RESULTS: At 12 months, the intensive intervention group had median declines of 3.0 mg/dL (to convert to millimoles per liter, multiply by 0.0555) in fasting plasma glucose and 4.5 mg/dL (to convert to millimoles per liter, multiply by 0.0113) in triglyceride levels compared with median increases of 1 mg/dL in fasting plasma glucose and 5.8 mg/dL in triglyceride levels in the moderate intervention group (P = .01 and P = .02, respectively). The median waist circumference decreased by 5.4 cm in the intensive intervention group and by 3.1 cm in the moderate intervention group (P = .10). The prevalence of the metabolic syndrome decreased by 4.0% in the intensive intervention group and increased by 5.2% in the moderate intervention group (P = .12). CONCLUSION: The 12-month culturally sensitive intensive lifestyle intervention was effective in improving some of the metabolic syndrome components in obese Arab women. Trial Registration clinicaltrials.gov Identifier: NCT00273572.
RCT Entities:
BACKGROUND: Few randomized controlled trials on lifestyle interventions have been reported in non-Western populations; none have been reported in Arab populations. METHODS: From 2 Muslim Arab communities in Israel, obese, nondiabetic women aged 35 to 54 years with 1 or more components of the metabolic syndrome were randomized to either an intensive (n = 100) or a moderate (control) (n = 101) 12-month lifestyle intervention. Women in the intensive intervention had 11 individual and 11 group counseling sessions per year with a dietitian and 22 physical activity group sessions per year. Women in the moderate intervention had 3 individual and 2 group dietary counseling sessions per year and no guided physical activity. Cultural issues were addressed in the design and conduct of both interventions. The primary outcome measure was change in the metabolic syndrome and its components. RESULTS: At 12 months, the intensive intervention group had median declines of 3.0 mg/dL (to convert to millimoles per liter, multiply by 0.0555) in fasting plasma glucose and 4.5 mg/dL (to convert to millimoles per liter, multiply by 0.0113) in triglyceride levels compared with median increases of 1 mg/dL in fasting plasma glucose and 5.8 mg/dL in triglyceride levels in the moderate intervention group (P = .01 and P = .02, respectively). The median waist circumference decreased by 5.4 cm in the intensive intervention group and by 3.1 cm in the moderate intervention group (P = .10). The prevalence of the metabolic syndrome decreased by 4.0% in the intensive intervention group and increased by 5.2% in the moderate intervention group (P = .12). CONCLUSION: The 12-month culturally sensitive intensive lifestyle intervention was effective in improving some of the metabolic syndrome components in obese Arab women. Trial Registration clinicaltrials.gov Identifier: NCT00273572.