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Effects of a Weight Management Program on Body Composition and Metabolic Parameters in Overweight ChildrenA Randomized Controlled Trial
Mary Savoye, RD, CD-N, CDE;
Melissa Shaw, BS;
James Dziura, PhD;
William V. Tamborlane, MD;
Paulina Rose, RD, CD-N, CDE;
Cindy Guandalini, APRN;
Rachel Goldberg-Gell, APRN;
Tania S. Burgert, MD;
Anna M. G. Cali, MD;
Ram Weiss, MD, PhD;
Sonia Caprio, MD
JAMA. 2007;297:2697-2704.
Context Pediatric obesity has escalated to epidemic proportions, leading to an array of comorbidities, including type 2 diabetes in youth. Since most overweight children become overweight adults, this chronic condition results in serious metabolic complications by early adulthood. To curtail this major health issue, effective pediatric interventions are essential.
Objective To compare effects of a weight management program, Bright Bodies, on adiposity and metabolic complications of overweight children with a control group.
Design One-year randomized controlled trial conducted May 2002-September 2005.
Setting Recruitment and follow-up conducted at Yale Pediatric Obesity Clinic in New Haven, Conn, and intervention at nearby school.
Participants Random sample of 209 overweight children (body mass index [BMI] >95th percentile for age and sex), ages 8 to 16 years of mixed ethnic groups were recruited. A total of 135 participants (60%) completed 6 months of study, 119 (53%) completed 12 months.
Intervention Participants were randomly assigned to either a control or weight management group. The control group (n = 69) received traditional clinical weight management counseling every 6 months, and the weight management group (n = 105) received an intensive family-based program including exercise, nutrition, and behavior modification. Intervention occurred biweekly the first 6 months, bimonthly thereafter. The second randomization within the weight management group assigned participants (n = 35) to a structured meal plan approach (dieting), but this arm of the study was discontinued while enrollment was ongoing due to a high dropout rate.
Main Outcome Measures Change in weight, BMI, body fat, and homeostasis model assessment of insulin resistance (HOMA-IR) at 6 and 12 months.
Results Six-month improvements were sustained at 12 months in weight management vs control, including changes in the following (mean [95% confidence interval]): weight (+0.3 kg [–1.4 to 2.0] vs +7.7 kg [5.3 to 10.0]); BMI (–1.7 [–2.3 to –1.1] vs +1.6 [0.8 to 2.3]); body fat (–3.7 kg [–5.4 to –2.1] vs +5.5 kg [3.2 to 7.8]); and HOMA-IR (–1.52 [–1.93 to –1.01] vs +0.90 [–0.07 to 2.05]).
Conclusion The Bright Bodies weight management program had beneficial effects on body composition and insulin resistance in overweight children that were sustained up to 12 months.
Trial Registration clinicaltrials.gov Identifier: NCT00409422
Author Affiliations: Yale Center for Clinical Investigation (Ms Savoye and Dr Dziura) and Department of Pediatric Endocrinology (Drs Tamborlane, Burgert, Cali, and Caprio, and Mss Shaw, Rose, Guandalini, and Goldberg-Gell), Yale University, New Haven, Conn; and Diabetes Center and Department of Pediatrics, Hadassah Hebrew University School of Medicine, Jerusalem, Israel (Dr Weiss).
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