OBJECTIVE: To determine if beneficial effects of a weight-management program could be sustained for up to 24 months in a randomized trial in an ethnically diverse obese population. PATIENTS AND METHODS: There were 209 obese children (BMI > 95th percentile), ages 8 to 16 of mixed ethnic backgrounds randomly assigned to theintensive lifestyle intervention or clinic control group. The control group received counseling every 6 months, and the intervention group received a family-based program, which included exercise, nutrition, and behavior modification. Lifestyle intervention sessions occurred twice weekly for the first 6 months, then twice monthly for the second 6 months; for the last 12 months there was no active intervention. There were 174 children who completed the 12 months of the randomized trial. Follow-up data were available for 76 of these children at 24 months. There were no statistical differences in dropout rates among ethnic groups or in any other aspects. RESULTS: Treatment effect was sustained at 24 months in the intervention versus control group for BMI z score (-0.16 [95% confidence interval: -0.23 to -0.09]), BMI (-2.8 kg/m(2) [95% confidence interval: -4.0-1.6 kg/m(2)]), percent body fat (-4.2% [95% confidence interval: -6.4% to -2.0%]), total body fat mass (-5.8 kg [95% confidence interval: -9.1 kg to -2.6 kg]), total cholesterol (-13.0 mg/dL [95% confidence interval: -21.7 mg/dL to -4.2 mg/dL]), low-density lipoprotein cholesterol (-10.4 mg/dL [95% confidence interval: -18.3 mg/dL to -2.4 mg/dL]), and homeostasis model assessment of insulin resistance (-2.05 [95% confidence interval: -2.48 to -1.75]). CONCLUSIONS: This study, unprecedented because of the high degree of obesity and ethnically diverse backgrounds of children, reveals that benefits of an intensive lifestyle program can be sustained 12 months after completing the active intervention phase.
RCT Entities:
OBJECTIVE: To determine if beneficial effects of a weight-management program could be sustained for up to 24 months in a randomized trial in an ethnically diverse obese population. PATIENTS AND METHODS: There were 209 obesechildren (BMI > 95th percentile), ages 8 to 16 of mixed ethnic backgrounds randomly assigned to the intensive lifestyle intervention or clinic control group. The control group received counseling every 6 months, and the intervention group received a family-based program, which included exercise, nutrition, and behavior modification. Lifestyle intervention sessions occurred twice weekly for the first 6 months, then twice monthly for the second 6 months; for the last 12 months there was no active intervention. There were 174 children who completed the 12 months of the randomized trial. Follow-up data were available for 76 of these children at 24 months. There were no statistical differences in dropout rates among ethnic groups or in any other aspects. RESULTS: Treatment effect was sustained at 24 months in the intervention versus control group for BMI z score (-0.16 [95% confidence interval: -0.23 to -0.09]), BMI (-2.8 kg/m(2) [95% confidence interval: -4.0-1.6 kg/m(2)]), percent body fat (-4.2% [95% confidence interval: -6.4% to -2.0%]), total body fat mass (-5.8 kg [95% confidence interval: -9.1 kg to -2.6 kg]), total cholesterol (-13.0 mg/dL [95% confidence interval: -21.7 mg/dL to -4.2 mg/dL]), low-density lipoprotein cholesterol (-10.4 mg/dL [95% confidence interval: -18.3 mg/dL to -2.4 mg/dL]), and homeostasis model assessment of insulin resistance (-2.05 [95% confidence interval: -2.48 to -1.75]). CONCLUSIONS: This study, unprecedented because of the high degree of obesity and ethnically diverse backgrounds of children, reveals that benefits of an intensive lifestyle program can be sustained 12 months after completing the active intervention phase.
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