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Laparoscopic Adjustable Gastric Banding in Severely Obese Adolescents: A Randomized Trial
O'Brien PE, Sawyer SM, Laurie C, et al. JAMA. 2010;303:519-526.
O'Brien and colleagues conducted a prospective, randomized trial comparing surgically placed gastric bands with lifestyle programs in severely obese adolescents. Outcomes of interest were the degree of weight loss, measures of health benefits (such as changes in blood pressure and evidence of the metabolic syndrome), and a measure of quality of life. The investigators hypothesized that the adolescents who had surgery would meet weight loss goals at higher rates than those enrolled in the lifestyle programs. The study ran from 2005 to 2008. Participants were 14-18 years of age; had body mass index (BMI) of at least 35; and had medical complications of obesity. In addition, all youths had attempted to lose weight for at least 3 years before enrollment. During a long run-in period, the investigators collected food diaries, baseline clinical data, and questionnaire information to obtain baseline psychosocial measures. After approximately 3 months of evaluation, the participants were randomly assigned in a 1:1 ratio to surgical intervention or a lifestyle program.
Participants were followed for 2 years and were seen clinically approximately every 6 weeks for reevaluation. The lifestyle program focused on reducing calorie intake and increasing activity. The caloric intake goal was between 800 and 2000 calories per day, and the activity goal was at least 30 minutes of daily activity, monitored by step counts. In addition, families received education, participated in group physical activities (eg, hikes and bike rides), and the participants had access to a personal trainer for 6 weeks. In the surgical group, the participants had the adjustable band placed within 1 month of random assignment. These youths were taught how to alter their diet to take smaller, more frequent meals and to exercise daily for at least 30 minutes. The primary outcome was the percentage of participants in each group who lost 50% of his or her excess weight (weight > 85th percentile of BMI for age and sex). The investigators also compared the groups on measures of health, quality of life, and number of adverse events. Quality of life measures were obtained at enrollment and at 2 years.
After screening 163 adolescents, 50 were randomly assigned to the lifestyle program or surgery group. Of the 25 participants assigned to the lifestyle program, 7 did not complete the study (4 withdrew because they were unhappy with their progress). Only 1 participant withdrew from the surgical intervention group. Data from all 50 participants were included in final analyses. The BMI of 46 of 50 (92%) participants was greater than the 99th percentile. In the surgical intervention group, 21 of 25 (84%) participants lost at least 50% of their excess weight, compared with only 3 of 25 (12%) participants in the lifestyle program group. The surgical group lost 10 times as much weight as the lifestyle group (mean, 34.5 kg vs 3.0 kg), corresponding to 28% weight loss among the surgical participants. At completion of the study, none of the surgical participants and 4 lifestyle program participants had the metabolic syndrome (compared with approximately 37% of all participants at enrollment). Eight patients in the surgical group required a revision during the 2-year period (30%), the only adverse event that differed between the groups. The surgical group demonstrated significantly improved quality of life on 5 of 8 subscales on the instrument used. The investigators concluded that surgical intervention with gastric banding was much more effective than a lifestyle modification program in reducing weight and improving health in adolescents.
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