ContextAdolescent obesity is becoming a national public health problem. Weight-loss medications including sibutramine facilitate weight control in adults and could be used with obese adolescents in combination with behavior therapy (BT).ObjectiveTo examine whether increased weight loss in obese adolescents is induced when sibutramine is added to a family-based, behavioral weight control program.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial consisting of 82 adolescents aged 13 to 17 years with a body mass index (BMI) of 32 to 44 conducted from March 1999 to August 2002 at a university-based clinic for 6 months, followed by open-label treatment during months 7 to 12.InterventionsFor the first 6 months, participants received either BT and sibutramine or BT and placebo. From months 7 to 12, all participants received sibutramine in open-label treatment.Main Outcome MeasuresPercentage change in BMI; systolic and diastolic blood pressure and pulse; and hunger.ResultsIn intention-to-treat analysis at month 6, participants in the BT and sibutramine group lost a mean (SD) of 7.8 kg (6.3 kg) and had an 8.5% (6.8%) reduction in BMI, which was significantly more than weight loss of 3.2 kg (6.1 kg) and reduction in BMI of 4.0% (5.4%) in the BT and placebo group. Significantly greater reductions in hunger (P = .002) also were reported by participants who received BT and sibutramine. From months 7 to 12, adolescents initially treated with sibutramine gained 0.8 kg (10.5 kg) with continued use of the medication, whereas those who switched from placebo to sibutramine lost an additional 1.3 kg (5.4 kg). Medication dose was reduced (n = 23) or discontinued (n = 10) to manage increases in blood pressure, pulse rate, or other symptoms.ConclusionsThe addition of sibutramine to a comprehensive behavioral program induced significantly more weight loss than did BT and placebo. Until more extensive safety and efficacy data are available, medications for weight loss should be used only on an experimental basis in adolescents and children.

BACKGROUND Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits. METHODS In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen. RESULTS At one year, subjects who received combined therapy lost a mean (+/-SD) of 12.1+/-9.8 kg, whereas those receiving sibutramine alone lost 5.0+/-7.4 kg, those treated by lifestyle modification alone lost 6.7+/-7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5+/-8.0 kg (P<0.001). Those in the combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently (18.1+/-9.8 kg vs. 7.7+/-7.5 kg, P=0.04). CONCLUSIONS The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone. The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.

BACKGROUNDThe contribution of familial factors to adiposity in children is poorly understood.OBJECTIVEThe objective was to assess differences in growth in the first 6 y of life in children born to either overweight or lean mothers.DESIGNThe body size and composition of 33 children at high risk and 37 children at low risk of obesity on the basis of the mother's overweight [body mass index (BMI; in kg/m(2)) of 30.2 +/- 4.2 and 19.5 +/- 1.1, respectively] were measured repeatedly from 3 mo to 6 y of age at the Children's Hospital of Philadelphia.RESULTSAt year 2, no significant differences in any measure were observed between the high- and low-risk groups. By year 4, weight, BMI, and lean body mass were greater in the high-risk than in the low-risk children. By year 6, weight was even greater in the high-risk than in the low-risk children (23.4 +/- 6.4 compared with 20.4 +/- 2.1 kg; P < 0.02), and, for the first time, fat mass was greater in the high-risk than in the low-risk children (6.7 +/- 5.7 compared with 3.8 +/- 1.2 kg; P < 0.02). Ten of 33 high-risk children exceeded the 85th percentile of BMI at year 6 compared with 1 of 37 low-risk children (odds ratio = 15.7). Accelerated weight gain was predicted by high-risk group status, greater weight at year 2, and lower family income.CONCLUSIONAnthropometric measures were not significantly different between groups at year 2; weight and lean body mass were greater at years 4 and 6, and fat mass was greater at year 6 in high-risk children.

BACKGROUNDSome investigators fear that dieting may precipitate binge eating and other adverse behavioral consequences.OBJECTIVEThe objective of the study was to examine whether dieting would elicit binge eating and mood disturbance in individuals free of these complications before treatment.DESIGNA total of 123 obese women were randomly assigned to 1) a 1000 kcal/d diet that included 4 servings/d of a liquid meal replacement (MR); 2) a 1200-1500 kcal/d balanced deficit diet (BDD) of conventional foods; or 3) a nondieting (ND) approach that discouraged energy restriction. All women attended weekly group sessions for 20 wk and biweekly sessions from week 20 to week 40.RESULTSAt week 20, participants in the MR, BDD, and ND groups lost 12.1 +/- 6.7%, 7.8 +/- 6.0%, and 0.1 +/- 2.4% of initial weight, respectively (P < 0.001). During the first 20 wk, there were no significant differences among groups in the number of persons who had objective binge episodes or in reports of hunger or dietary disinhibition. Symptoms of depression decreased significantly more (P < 0.001) in the MR and BDD groups than in ND participants. At week 28, significantly more (P < 0.003) cases of binge eating were observed in MR participants than in the 2 other groups. No differences, however, were observed between groups at weeks 40 or 65 (a follow-up visit). At no time did any participant meet criteria for binge-eating disorder.CONCLUSIONConcerns about possible adverse behavioral consequences of dieting should not dissuade primary care providers from recommending modest energy restriction to obese individuals.

Background. Parental feeding styles were linked to child weight in cross-sectional studies, which were unable to test the direction of effect. Prospective studies can best establish causal relationships among such variables. Objective. We tested the 2-year stability of parental feeding attitudes and styles and investigated whether these variables predict child body mass index (BMI) z scores 2 years later. We evaluated whether these associations were dependent on children’s predisposition to obesity. Methods. Participants were 57 families enrolled in an Infant Growth Study of children born at high risk or low risk for obesity, on the basis of maternal prepregnancy overweight or leanness. Children were evaluated for weight and height at 3, 5, and 7 years of age. Measures of parental feeding attitudes and styles were ascertained with the Child Feeding Questionnaire at 5 and 7 years of age. Correlation and multiple regression analyses tested whether parental feeding styles at age 5 predicted increased child BMI z scores 2 years later. Results. Parental feeding attitudes and styles were stable for child ages of 5 to 7 years. With respect to feeding attitudes, perceived responsibility at age 5 predicted reduced child BMI z scores at age 7 among low-risk families, whereas child weight concern and perceived child weight predicted increased child BMI z scores among high-risk families. With respect to feeding styles, monitoring predicted reduced child BMI z scores at age 7 among low-risk children. In contrast, restriction predicted higher BMI z scores and pressure to eat predicted reduced BMI z scores among high-risk children. These associations remained significant after controlling for child weight status at age 3. Conclusions. The relationship between parental feeding styles and child BMI z scores depends on child obesity predisposition, suggesting a gene-environment interaction. Among children predisposed to obesity, elevated child weight appears to elicit restrictive feeding practices, which in turn may produce additional weight gain. Parenting guidelines for overweight prevention may benefit from consideration of child characteristics such as vulnerability to obesity and current weight status.

BACKGROUND:Weight loss medications are recommended as an adjunct to diet and exercise modification but seem to be prescribed as a monotherapy by many physicians. This practice is likely to be associated with suboptimal weight loss.METHODS:This 1-year, randomized trial compared the effects of sibutramine hydrochloride used alone (ie, the drug-alone group) to sibutramine plus group lifestyle modification, prescribed with either a 5021- to 6276-kJ/d diet (1200-1500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4184-kJ/d diet (1000-kcal/d diet (ie, drug-plus-lifestyle with a portion-controlled diet [the combined treatment] group). Participants were 53 women with a mean (+/-SD) age of 47.2 +/- 9.8 years and weight of 101.3 +/- 9.7 kg. At baseline, they reported the number of pounds they expected to lose at the end of treatment.RESULTS:At month 12, patients treated with the drug alone lost (mean +/- SD) 4.1% +/- 6.3% of their initial body weight compared with significantly (P<.05) larger losses in the drug-plus-lifestyle group of 10.8% +/- 10.3% and the combined treatment group of 16.5% +/- 8.0%. Women in the 2 lifestyle groups achieved a significantly (P<.05) greater percentage of their expected weight loss than those in the drug-alone group and were significantly more satisfied with the medication and with changes in weight, health, appearance, and self-esteem (P<.05 for all). Significant reductions were observed at 12 months in triglyceride and low-density lipoprotein cholesterol levels but systolic and diastolic blood pressure both increased significantly (P<.05 for all).CONCLUSION:The addition of group lifestyle modification to the pharmacologic management of obesity significantly improved weight loss and patients' satisfaction with treatment outcome.

We have previously reported on the effects of 16 weeks of treatment by sibutramine, combined with either orlistat or placebo, in 34 women who had completed an initial 52 weeks of therapy with sibutramine alone (1, 2). Adding orlistat to sibutramine did not increase weight loss. Thus, the two medications did not seem to have additive effects, although there was a trend in this direction for women who lost <10% of their initial weight. The 26 women who completed our full 68-week study had a mean loss of 11.7% ± 9.7% of their initial weight. In an exit interview, all participants were encouraged by the study physician (R.I.B.) to continue to take sibutramine to facilitate the maintenance of weight loss. They also were sent a letter that reiterated this recommendation. Patients were advised to ask their personal physician to prescribe sibutramine, and they were expected to pay for the medication, which had been provided free of charge in the previous trial. The study physician offered to provide a 1-month carryover prescription for patients who expected delays in seeing their personal physician. These 26 women were contacted at week 104 (i.e., 2 years from baseline) to determine their success in maintaining their weight loss. Based on the results of two randomized trials (3, 4), we predicted that patients who continued to take sibutramine would maintain their weight loss significantly better than those who discontinued medication. We also wished to identify factors associated with the decision to continue or discontinue medication. Body weight was obtained for 24 of 26 women, 17 of whom returned to the clinic. Seven others reported their weights by returning questionnaires; 2 kg were added to self-reported weights to correct for underreporting. Two patients declined to participate in the follow-up study, citing disappointment with their outcomes. The five patients who remained on medication during the follow-up period (i.e., weeks 68 to 104) lost an additional 2.2 ± 7.6 kg during this time, whereas those who discontinued medication at the end of the 68-week trial (N = 13) or during the course of the follow-up (N = 6) gained 4.7 ± 5.7 kg and 4.1 ± 6.7 kg, respectively. (Patients who discontinued medication during follow-up did so at an average of 77.7 ± 6.5 weeks postbaseline.) ANOVA revealed a significant (p < 0.02) difference in weight change among the three groups from weeks 68 to 104, with women who continued on sibutramine achieving significantly better maintenance of weight loss than those in the two other groups. Patients who remained on medication rated the extent to which each of nine factors had motivated them to do so. Ratings were made on 9-point Likert-type scales, where 1 = strongly disagree and 9 = strongly agree. The top three reasons participants continued taking sibutramine were because “it helped me to keep my weight down” (7.2 ± 1.1), “it helped me control my appetite” (6.6 ± 0.7), and “the staff at the University of Pennsylvania encouraged me to continue taking MERIDIA” (6.2 ± 0.8; Knoll Pharmaceutical Co., Chicago, IL). Patients who discontinued medication at week 68 rated the extent to which 10 factors motivated them to do so. The top three reasons were because “I began to gain weight while taking MERIDIA” (5.0 ± 1.5), “I don't like the idea of taking any medication long-term” (5.0 ± 1.2), and “I was concerned about the side effects of MERIDIA” (4.9 ± 1.4). The principal finding of this study is that continued use of medication after weight loss seemed to facilitate weight maintenance, as has been shown in randomized trials of both sibutramine (3, 4) and orlistat (5, 6). However, fewer than 25% of participants continued to take medication after our 68-week trial concluded, despite our advice that they do so. Patients who discontinued therapy had a significantly poorer outcome. Weight-loss medications only work if patients take them long-term, yet most weight-loss prescriptions are filled for fewer than 75 days. This is a serious problem in the pharmacological treatment of obesity and in the management of other chronic conditions. Paradoxically, the patients who discontinued sibutramine at week 68 because they thought it was no longer effective could only fully realize the medication's benefit after they stopped taking it (and gained 4.7 kg during the follow-up period). We must find better ways to help patients understand the potential benefits of long-term pharmacological management of their obesity. This study was supported, in part, by National Institutes of Health Grant DK56124-02 and by a grant from Knoll Pharmaceutical Co., an Abbott company.

Objective: This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight while taking sibutramine alone.Research Methods and Procedures: Patients were 34 women with a mean age of 44.1 +/- 10.4 years, weight of 89.4 +/- 13.8 kg, and body mass index (BMI) of 33.9 +/- 4.9 kg/m(2) who had lost an average of 11.6 +/- 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double-blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification visits during the 16-week continuation trial.Results: Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight loss as compared with treatment by sibutramine alone (mean changes = +0.1 +/- 4.1 kg vs. +0.5 +/- 2.1 kg, respectively).Discussion: These results must be interpreted with caution because of the study's small sample size. The findings, however, suggest that the combination of sibutramine and orlistat is unlikely to have additive effects that will yield mean losses greater than or equal to 15% of initial weight, as desired by many obese individuals.

Background: It has been proposed that the primary determinants of body weight at 1 y of age are genetic background, as represented by parental obesity, and low total energy expenditure. Objective: The objective was to determine the relative contributions of genetic background and energy intake and expenditure as determinants of body weight at 1 y of age. Design: Forty infants of obese and 38 infants of lean mothers, half boys and half girls, were assessed at 3 mo of age for 10 risk factors for obesity: sex, risk group (obese or nonobese mothers), maternal and paternal body mass index, body weight, feeding mode (breast, bottle, or both), 3-d energy intake, nutritive sucking behavior during a test meal, total energy expenditure, sleeping energy expenditure, and interactions among them. Results: The only difference between risk groups at baseline was that the high-risk group sucked more vigorously during the test meal. Four measures accounted for 62% of the variability in weight at 12 mo: 3-mo weight (41%, P = 0.0001), nutritive sucking behavior (9%, P = 0.0002), 3-d food intake (8%, P = 0.0002), and male sex (3%, P = 0.05). Food intake and sucking behavior at 3 mo accounted for similar amounts of variability in weight-for-length, body fat, fat-free mass, and skinfold thickness at 12 mo. Contrary to expectations, neither total nor sleeping energy expenditure at 3 mo nor maternal obesity contributed to measures of body size at 12 mo. Conclusions: Energy intake contributes significantly to measures of body weight and composition at 1 y of age; parental obesity and energy expenditure do not.

OBJECTIVE: To assess the relationship between the measures of body weights of parents and those of their children during the first two years of life. SUBJECTS: Seventy-eight infants born to obese (‘high risk’) or nonobese (‘low risk’) mothers. METHODS: Weight, weight for length and skinfold thicknesses of the high and low risk infants were measured at 3 months, 12 months and 24 months of age. A multiple linear regression analysis assessed the contributions of nine risk factors, including paternal and maternal body mass index (BMI: kg/m2), to the weight and weight for length of infants at 12 months and 24 months of age. RESULTS: There were no differences between the high and low risk groups in weight, weight for length or skinfold thicknesses at 3 months, 12 months or 24 months of age. Neither paternal nor maternal BMI entered the multiple regression. CONCLUSIONS: These results suggest that genetic influences on the body weight of infants may be independent of those that influence BMI in adults, a circumstance that could complicate the search for genetic determinants of obesity.

The goal of obesity treatment has changed significantly in the past decade. Where once the goal was a reduction to ideal weight, the current objective is the achievement of a healthier weight. For many obese individuals, this means losing as little as 5-15% of their initial weight. This article briefly describes behavioural methods to help obese individuals modify their eating and activity habits in order to achieve these new goals. A review of recent studies shows that patients treated by a comprehensive group behavioural programme lose approximately 9% of their initial weight in 20 weeks and, without further treatment, maintain a loss of 5% 1 year later. Methods of improving the maintenance of weight loss include increasing physical activity, extending the length of behavioural treatment and, with appropriately selected individuals, combining behavioural and pharmacological interventions. The importance of helping obese individuals adopt realistic treatment expectations is also discussed.

OBJECTIVE To assess weight loss, as well as the prevalence of valvular heart disease, in 21 obese women who completed 2 years of treatment by fenfluramine and phentermine (fen-phen) in June 1997. RESEARCH METHODS AND PROCEDURES Patients were 21 of 22 women who had completed a 1-year, open-label trial of fen-phen combined with lifestyle modification. This study describes the results of a second year of treatment. The presence of valvular heart disease, defined as aortic regurgitation of mild or greater severity and/or mitral regurgitation of moderate or greater severity, was assessed using two-dimensional, color Doppler and pulsed- and continuous-wave Doppler examinations. RESULTS At 2 years, the 21 patients had a mean reduction in initial weight of 13.9 + 10.0%, which was significantly (p<0.001) smaller than their 1-year loss of 17.1 +/- 8.7%. Nine of 21 patients reported that they took fen-phen irregularly during the last 4 months of the study because of fears of developing health complications. These nine patients had a 2-year weight loss of 8.7 +/- 7.5%, compared with a significantly (p<0.04) larger loss of 17.6 +/- 10.5% for participants who reported taking medication regularly. Six of 20 (30%) patients met criteria for valvular heart disease. None of the six had signs or symptoms of this condition. DISCUSSION Fenfluramine was withdrawn from the market on September 15, 1997 because of concerns that it was associated with valvular heart disease. The present findings are discussed in terms of the potentially favorable long-term benefits of combining lifestyle modification with weight loss medications that are both safe and effective.

To measure infant nutritive sucking reproducibly, nipple flow resistance must be controlled. Previous investigators have accomplished this with flow-limiting venturis, which has two limitations: flow resistance is highly dependent on fluid viscosity and older infants often reject the venturi nipple. This report describes the validation of calibrated-orifice nipples for the measurement of infant nutritive sucking. The flow characteristics of two infant formulas and water through these nipples were not different; those through venturi nipples were (analysis of variance; p < 0.0001). Flow characteristics did not differ among calibrated-orifice nipples constructed from three commercial nipple styles, indicating that the calibrated-orifice design is applicable to different types of baby bottle nipples. Among 3-month-old infants using calibrated-orifice nipples, acceptability was high, and sucking accounted for 85% of the variance in fluid intake during a feeding. We conclude that calibrated-orifice nipples are a valid and acceptable tool for the measurement of infant nutritive sucking. (J Pediatr 1998;132:523-6)