Mean Body Mass Index Reduction Research Articles

Metabolic outcomes of matched patient populations initiating exenatide BID vs. insulin glargine in an ambulatory care setting

This observational study evaluated the clinical effectiveness of exenatide BID (exenatide) vs. insulin glargine (glargine) in patients with type 2 diabetes mellitus in ambulatory clinical practice. Retrospective analyses were conducted using an electronic medical record (EMR) database among adult patients with type 2 diabetes mellitus initiating exenatide or glargine between 1 November 2006 and 30 April 2009. The cohorts were propensity-score matched to control baseline demographics, clinical measures, health status and medication use. The changes from baseline to a 12-month follow-up period for A1C (primary outcome), weight, body mass index (BMI), blood pressure and lipid levels were compared between the matched cohorts using paired tests. Propensity-score matching between the exenatide (n = 4494) and glargine (n = 5424) cohorts led to 2683 matched pairs with comparable characteristics, including age, gender and baseline clinical values. The exenatide cohort achieved a greater mean reduction in A1C (-0.6% vs. -0.4%, p < 0.01), weight (-2.6 kg vs. -0.2 kg, p < 0.01), BMI (-0.8 kg/m(2) vs. -0.04 kg/m(2) , p < 0.01) and systolic blood pressure (SBP) (-1.8 mmHg vs. -0.1 mmHg, p < 0.01) in the follow-up period. The changes in diastolic blood pressure and lipid levels were not significantly different between cohorts. Compared to glargine, exenatide-treated patients experienced significant reductions in A1C, weight, BMI and SBP. Acknowledging the limitations of observational research, exenatide showed greater clinical effectiveness than glargine from a large EMR database in the ambulatory care setting.

Effects of dietary weight loss on obstructive sleep apnea: a meta-analysis

Clinical and epidemiologic investigations suggest a strong association between obesity and obstructive sleep apnea (OSA). The purpose of this study is to evaluate the currently available literature reporting on the effectiveness of dietary weight loss in treating OSA among obese patients. Relevant studies were identified by computerized searches of PubMed, EMBASE, CINAHL, Web of Science, and The Cochrane Central Register of Controlled Trials through September 2011 as well as the reference lists of all obtained articles. Information on study design, patient characteristics, pre- and post-dietary weight loss measures of OSA and body mass index (BMI), and study quality was obtained. Data were extracted by two independent analysts. Weighted averages using a random-effects model are reported with 95 % confidence intervals. Nine articles representing 577 patients were selected. Dietary weight loss program resulted in a pooled mean BMI reduction of 4.8kg/m(2) (95 % confidence interval [CI] 3.8-5.9). The random-effects pooled apnea hypopnea (AHI) indices at pre- and post-dietary intervention were 52.5 (range 10.0-91.0) and 28.3 events/h (range 5.4-64.5), respectively (p < 0.001). Compared to control, the weighted mean difference of AHI was decreased by -14.3 events/h (95 % CI -23.5 to -5.1; p = 0.002) in favor of the dietary weight loss programs. Dietary weight loss programs are effective in reducing the severity of OSA but not adequate in relieving all respiratory events. Weight reduction programs should be considered as adjunct rather than curative therapy.

Obesity trends in Russia. The impact on health and healthcare costs

Similar to most developed countries, obesity rates inRussiahave been steadily increasing. This has led to a high burden of obesity related diseases and associated healthcare costs. The micro-simulation model has been utilized to project body mass index (BMI) and BMI related disease burden and healthcare costs. Incidence, mortality, survival and healthcare costs were collected for thirteen diseases. The results have been simulated for 3 hypothetical scenarios to project a potential impact of policy interventions: 1) assuming no reduction in BMI; 2) 1% reduction in mean BMI across the population; 3) 5% reduction in mean BMI across the population. Nearly 58% of the female population was obese (BMI ≥30 kg/m2) or overweight (BMI 25 -29.9 kg/m2) in 2010, and the prevalence is projected to decrease to 54% in 2050. The rates are predicted to increase for men from 51% in 2010 to 76% in 2050. The prevalence rates will triple for some obesity-related diseases. A one percent decrease in BMI across the population will save more than two billion US Dollars in 2030 and 2050. Despite female obesity prevalence starting at a higher point than the men, obesity is predicted to increase in males but not females. Disease and economic burden attributed to these obesity rates are still severe and the country should implement strong policies to tackle the obesity epidemic.

Revisionary bariatric surgery: indications and outcome of 100 consecutive operations at a single center

A growing number of revisionary and secondary bariatric operations have been performed in recent years, with the number of operations doubling each year at the authors' center. Diagnostics, indications, and most revisionary operations should be performed by an experienced bariatric surgeon. This study was undertaken to evaluate indications and outcomes of revisionary bariatric operations at a specialized center. At the Centre of Obesity and Metabolic Surgery (University of Freiburg, Germany), 100 consecutive revisionary bariatric operations performed between March 2007 and September 2009 were analyzed concerning indications and outcomes. Only 9 of the 100 revisions were due to early complications (<30 days after the primary operation). The indication for most revisions was poor weight loss (n = 55). A mean body mass index reduction of 10 points could be achieved in 1 year, which equals a 56% excess weight loss (EWL). No significant difference in weight reduction between restrictive and malabsorptive revisions was observed. Revisions due to implant-related problems also were frequent (n = 25). Laparoscopic revision was possible in 95% of the cases. Insufficient weight loss is the most frequent indication for revisionary bariatric surgery. The surgery can be performed laparoscopically in most cases, and a significant EWL (> 50%) can be achieved in 1 year if the right revisionary procedure is chosen.

Effectiveness of interventions to promote healthy weight in general populations of children and adults: a meta-analysis

Responding to the obesity epidemic requires robust evidence to help prioritize the allocation of scarce resources to preventive interventions. The aim of this study was to evaluate interventions that promote healthy weight [defined as reduction in body mass index (BMI) or percentage body fat] in general populations (unselected by weight) using a comprehensive meta-analysis. Interventions with both single and multiple components were considered. Studies were first identified through well-conducted systematic reviews complemented by a search for single studies in five large medical databases up to 6 November 2008. Sixty-eight controlled studies were included. For each intervention type and age group, all relevant studies were pooled in a random effects meta-analysis. In children, the highest reductions in mean BMI were achieved through promoting reduced television viewing [-0.27 kg/m(2) (95% CI -0.4 to -0.13 kg/m(2))]. Programmes combining physical activity, specifically themed or general health education and nutrition achieved a lower reduction [-0.1 kg/m(2) (95% CI -0.17 to -0.04 kg/m(2))]. Other interventions had high heterogeneity or showed no statistically significant reduction in outcomes. In adults, single component interventions were found to reduce both outcome measures. Their mean percentage body fat was reduced through education by -1.22% (95% CI -1.92 to -0.52). The evidence for the effectiveness of promoting healthy weight in general populations is limited, though multi-component interventions in schools and encouraging reduced children's television viewing are promising strategies. Improving the reporting of outcomes is vital, as imputation of inadequately reported measures may have contributed to the observed heterogeneity. Longer follow-up is essential for understanding policy relevance.

Zonisamide produces weight loss in psychotropic drug-treated psychiatric outpatients

This study examined the long-term effectiveness and tolerability of zonisamide for weight control in psychiatric outpatients using various psychotropic medications. We conducted a systematic chart review of 82 psychiatric outpatients with unwanted weight gain after the introduction of psychotropic drugs between January 2008 and September 2009 at Korea University Ansan Hospital. The primary outcome measure was the effect of zonisamide on body mass index (BMI). Additional outcome measures included safety and tolerability as assessed by the clinical global impression-severity of illness scale (CGI-S) and discontinuation rate. The mean final dose of zonisamide was 124.6±53.4 mg/day and ranged from 50mg/day to 300 mg/day. The mean BMI reduction was 0.8±1.7 kg/m(2) and ranged from -2.9 kg/m(2) to 4.7 kg/m(2) (p<0.001). We also observed a significant reduction in CGI-S scores from the baseline (3.8±0.9) to the endpoint (3.3±0.8; p<0.001). Twelve patients (14.6%) discontinued their zonisamide treatment due to its side effects. Patients treated with zonisamide showed significant weight loss. Furthermore, its treatment was generally safe and well tolerated with few negative effects on patients' overall psychiatric symptoms. Additional research is required to confirm these results and to investigate whether patients have rebound weight gains after discontinuing zonisamide.

Changes in body weight, body composition and cardiovascular risk factors after long-term nutritional intervention in patients with severe mental illness: an observational study

BackgroundCompared with the general population, individuals with severe mental illness (SMI) have increased prevalence rates of obesity and greater risk for cardiovascular disease. This study aimed to investigate the effects of a long term nutritional intervention on body weight, body fat and cardiovascular risk factors in a large number of patients with SMI.MethodsNine hundred and eighty-nine patients with a mean ± S.D age of 40 ± 11.7 yrs participated in a 9 mo nutritional intervention which provided personalised dietetic treatment and lifestyle counselling every two weeks. Patients had an average body mass index (BMI) of 34.3 ± 7.1 kg.m-2 and body weight (BW) of 94.9 ± 21.7 kg. Fasted blood samples were collected for the measurement of glucose, total cholesterol, triglycerides and HDL- cholesterol. All measurements were undertaken at baseline and at 3 mo, 6 mo and 9 mo of the nutritional intervention.ResultsFour hundred and twenty-three patients of 989 total patients' cases (42.8%) dropped out within the first 3 months. Two hundred eighty-five completed 6 months of the program and 145 completed the entire 9 month nutritional intervention. There were progressive statistically significant reductions in mean weight, fat mass, waist and BMI throughout the duration of monitoring (p < 0.001). The mean final weight loss was 9.7 kg and BMI decreased to 30.7 kg.m-2 (p < 0.001). The mean final fat mass loss was 8.0 kg and the mean final waist circumference reduction was 10.3 cm (p < 0.001) compared to baseline. Significant and continual reductions were observed in fasting plasma glucose, total cholesterol and triglycerides concentrations throughout the study (p < 0.001).ConclusionThe nutritional intervention produced significant reductions in body weight, body fat and improved the cardiometabolic profile in patients with SMI. These findings indicate the importance of weight-reducing nutritional intervention in decreasing the cardiovascular risk in patients with SMI.

HEADS UP

This first published RCT randomised 50 Melbourne adolescents aged 14–18 years with a body mass index (BMI) > 35 kg/m2 to either a supervised lifestyle weight loss intervention program or to laparoscopic adjustable gastric banding. Outcomes included weight loss and markers of increased health risk after two years. The attrition rate was higher in the lifestyle intervention group (28%) than the gastric banding group (4%). The mean weight loss in the gastric banding group was 34.6 kg (28.3% of total body weight) with a mean reduction in BMI of 12.7 units and in BMI Z Score of 1.08 units. The lifestyle intervention group had a mean weight loss of 3 kg (3.1% of total body weight) with a mean reduction in BMI of 1.3 units and in Z Score of 0.23 units. The markers of increased health risk (metabolic syndrome and insulin resistance) and waist circumference significantly favoured gastric banding. None of the gastric banding group had metabolic syndrome at two years. Almost half the gastric banding participants (48%) experienced an adverse event and seven patients required a revisional procedure. General health improved significantly in both groups. The Royal Australasian College of Physicians is about to publish a policy document on gastric banding for adolescents, which includes ethical considerations. Link: http://jama.ama-assn.org/cgi/content/full/303/6/519 Submitted by Shirley Alexander (shirleya@chw.edu.au) Two randomised controlled trials studied prophylactic paracetamol for routine vaccinations. As expected, the proportion of febrile children (>38°C) was significant lower in the group receiving paracetamol (three doses over 24 h) following primary and booster vaccinations compared with the children who received no paracetamol. An unexpected finding was the possible influence of prophylactic paracetamol on vaccine immunogenicity. The children in the paracetamol group had significantly lower antibody geometric mean titres and/or opsonophagocytic activity following primary infant vaccination with pneumococcal conjugate, Haemophilus influenzae type b, diphtheria and tetanus vaccines. No differences were observed in responses to polio, hepatitis B and rotavirus. The differences persisted following pneumococcal booster vaccination. Importantly, however, there was no difference in the proportion of children considered ‘protected’, on the basis of quantitative antibody thresholds, between the two groups. This effect of paracetamol was unrelated to the effect on fever. An immunological effect of paracetamol, a cycloxygenase-2 inhibitor, has biological plausibility and is consistent with other reported detrimental effects of paracetamol. Since the relationship between peak serologic response post-vaccination and long-term clinical protection is not completely clear, the findings of this study do not necessarily imply that prophylactic paracetamol reduces vaccine efficacy. However, for pneumococcal conjugate vaccination, this study showed reduction in functional as well as quantitative responses. The public health implications of an attenuated immunological response associated with fever prophylaxis with vaccination invite caution. While further data are needed, these results support current practice of not routinely recommending prophylactic paracetamol with infant vaccinations. Submitted by Ben Gelbart (ben.gelbart@rch.org.au); Penelope Bryant (penelope.bryant@rch.org.au).

Analysis of Safety and Efficacy of Intragastric Balloon in Extremely Obese Patients

The implantation of an intragastric balloon constitutes a short-term effective non-surgical intervention to lose weight. The aim of this study was to evaluate retrospectively the clinical outcome and safety of gastric balloon therapy (GBT) in extremely obese patients. One hundred and nine super- and super-super-obese patients, 64 males and 45 females, mean age 39.1+/-8.4 years, mean body mass index (BMI) 68.8+/-8.9 kg/m2, who underwent GBT for weight loss, were studied retrospectively. GBT was assessed in massively obese patients concerning tolerance, weight loss, number of comorbidities and complications. A significant reduction in patients' weight and BMI was evident after GBT. Regarding safety, no major complications occurred. Minor complications at balloon placement and removal occurred in one (0.9%) and three patients (2.8%) respectively. Mean duration of GBT was 177.6+/-56.8 days. After GBT, the mean weight loss was 26.3+/-15.2 kg (p<0.001) and the mean BMI reduction was 8.7+/-5.1 kg/m2 (p<0.001) representing a mean percentage of excess BMI lost (%EBL) of 19.7+/-10.2. The highest BMI loss was observed in patients with BMI>80 kg/m2. A noteworthy improvement of comorbidities in 56.8% of the patients was also noted. Of the 109 patients, 69 received subsequent bariatric surgery. All the procedures were performed laparoscopically. Ten patients, with a mean BMI of 68.6+/-10.6 kg/m2 after the removal of the first BIB, received a second BIB resulting in a non-significant weight and BMI loss of 6.3+/-9.4 kg and 1.8+/-2.9 kg/m2, respectively. Our study indicates the safety and efficacy of GBT in extremely obese patients particularly as a first step before a definitive anti-obesity operation. GBT appears to be a safe, tolerable, and potentially effective procedure for the initial treatment of morbid obesity.

Self-monitoring predicts change in fiber intake and weight loss in adults with diabetes following an intervention regarding the glycemic index

Objective Self-monitoring can facilitate behavioral change by providing feedback regarding goal attainment. Glycemic index (GI) quantifies the glycemic response to carbohydrate-containing foods. Low GI diets may improve weight and glycemic control. We examined the relation between self-monitoring and changes in diet and body weight following an intervention in which consumption of low GI foods was encouraged among adults aged 40–70 years with diabetes. Methods Pre/post-intervention dietary intake was assessed with 24-h dietary recalls and weight was obtained. Mean number of days participants kept self-monitoring records was determined. The impact of self-monitoring on the change in GI, fiber intake, weight and body mass index (BMI) was evaluated using regression analyses. Results Each additional day of self-monitoring was associated with a mean reduction in weight and BMI of −0.95 kg and −0.34 kg/m 2, respectively. The mean change in fiber intake increased in men but did not significantly change in women for each additional day of monitoring. Conclusion Self-monitoring was associated with weight loss in men and women and greater fiber intake in men. Practice Implications Men can self-monitor to lose weight and increase fiber intake. Self-monitoring facilitates weight loss in women but other behavioral strategies are needed to improve fiber intake.

Efectividad, seguridad y tolerancia del balón intragástrico asociado a una dieta hipocalórica para la reducción de peso en pacientes obesos

the endoscopic placement of an intragastric balloon (IGB) in association with a low-calorie diet is an option for the treatment of obesity. The aim of the present study was to evaluate its effectiveness, safety, and tolerance. thirty-eight patients with no contraindications for IGB were included in this prospective study from March 2004 to January 2007. Balloon removal was performed 6 months later. Weight and body mass index (BMI) were evaluated after IGB removal and at 6 months and 1 year thereafter. Tolerance and complications during treatment were evaluated. Patients filled out a questionnaire to evaluate their subjective perception of treatment. mean weight loss after 6 months on balloon treatment was 14.10 kg (0-46), and mean BMI reduction was 5.23 kg/m2 (0-18). At 12 months after balloon removal 48.4% of patients maintained their weight loss or kept loosing weight. Most common early symptoms included nausea (71.1%) and vomiting (57.9%) with a good response to symptomatic treatment. Complications were seen in 7 patients (18.4%): digestive intolerance in 4 patients, with early removal in 3 of them; moderate esophagitis in 2 patients; and gastric perforation complicated with septic shock and death in 1 patient. 1. IGB in association with low-calorie diet is an effective, safe, and well tolerated treatment for morbid obese patients.2. Almost half of patients maintained their weight loss after one year from balloon removal.

Efficacy of Add-On Topiramate Therapy in Psychiatric Patients with Weight Gain

Weight gain is a common adverse effect of many psychotropic medications including antipsychotics, antidepressants, and mood stabilizers. There is a growing body of evidence that topiramate may be useful as an add-on therapy to induce weight loss in patients who have experienced psychotropic-induced weight gain. To determine the efficacy and tolerability of topiramate for treatment of weight gain in a naturalistic mental health clinic setting. A retrospective chart review was conducted at a community mental health clinic. Subjects were non-elderly adults who received topiramate therapy beginning in 2002-2005 for documented weight gain during treatment with psychotropic drugs. Primary outcome measures included response rate (based on weight loss of any magnitude) and mean changes in weight and body mass index (BMI). Forty-one patients were included in the study. There was a 58.5% (n = 24) response rate. Mean reductions in weight and BMI were approximately 2.2 kg and 0.5 points, respectively. Responders lost an average of 7.2 kg, whereas nonresponders gained an average of 5.0 kg. Patients with a baseline weight of at least 91 kg and those receiving a greater number of psychotropic medications were more likely to experience success with topiramate therapy. Of the 24 patients who responded to therapy, 22 experienced onset of weight reduction by the next clinic visit (1-4 mo) following either initiation of therapy or titration to the eventual therapeutic dose, and the usual rate of weight loss was 0.45-1.4 kg per month. Therapy was typically initiated at 50 mg/day. The mean maximum dose was 93.9 mg/day and the median maximum dose was 100 mg/day. Seven (17.1%) patients had documented adverse effects to topiramate therapy. Topiramate therapy resulted in overall modest (ie, <2%) decreases in weight and BMI, but many patients experienced more impressive weight loss. Therapy was generally well tolerated.

GP supply and obesity

We investigate the relationship between area general practitioner (GP) supply and individual body mass index (BMI) in England. Individual level BMI is regressed against area whole time equivalent GPs per 1000 population plus a large number of individual and area level covariates. We use instrumental variables (area house prices and age weighted capitation) to allow for the endogeneity of GP supply. We find that that a 10% increase in GP supply is associated with a mean reduction in BMI of around 1 kg/m 2 (around 4% of mean BMI). The results suggest that reduced list sizes per GP can improve the management of obesity.

Laparoscopic Mini-gastric Bypass: Experience with Tailored Bypass Limb According to Body Weight

Gastric bypass surgery is an effective and long-lasting treatment of morbidly obese patients. However, the bypass limb may need to be tailored in morbidly obese patients with a wide range of obesity. The aim of the present study was to report clinical result of tailored bypass limb in a group of patients receiving laparoscopic mini-gastric bypass surgery. From Jan 2002 to Dec 2006, laparoscopic mini-gastric bypass was performed in 644 patients [469 women, 175 men: mean age 30.5 +/- 8.1 years; mean body mass index (BMI) 43.1 +/- 6.0] in our department. The gastric bypass limb was tailored according to the preoperative BMI. The clinical data and outcomes were analyzed. All the clinical data were prospectively collected and stored. Two hundred eighty-six patients belonged to lower BMI (BMI < 40; mean 36.0), 286 patients moderate BMI (BMI 40-50; mean 43.2), and 72 patients higher BMI (BMI > 50; mean 55.4). All procedures were completed laparoscopically. Mean operative time was 130 min, and mean hospital stay was 5.0 days. Twenty-three minor early complications (4.3%) and 13 major complications (2.0%) were encountered, with one death occurred (0.016%). There was no significant difference in operation time and complication rate between the groups. The mean bypass limb was 150 cm for the lower BMI group, 250 cm for moderate BMI group, and 350 cm for the higher BMI group. The mean BMI reduction 2 years after surgery was 10.7, 15.5, and 23.3 for the lower, moderate, and higher BMI group. The weight loss curves and resolution of obesity related comorbidities were compatible with the tailored bypass limbs between the groups. However, the lower BMI patients had more severe anemia than the other two groups. Morbidly obese patients receiving gastric bypass surgery may need to tailor the bypass limb according to BMI. The application of gastric bypass in lower BMI patients should be more carefully.

Long‐term maintenance of weight loss in patients with severe mental illness through a behavioural treatment programme in the UK

Obesity is common among people with severe mental illness (SMI). We report our experience from the first 4 years of The Cromwell House weight management clinic. Ninety-three patients with SMI aged 43.7 +/- 1.2 years referred themselves to this clinic. The patients were seen in weekly group sessions that involved weight measurement, discussion and education. Mean baseline weight was 89.5 +/- 1.8 kg [body mass index (BMI) 32.3 +/- 0.5 kg/m(2)]. Twenty-three per cent dropped out within the first 8 weeks. There was progressive statistically significant reduction in mean weight and BMI throughout the duration of monitoring with no suggestion of a plateau. The mean final weight loss was 6.2 +/- 0.6 kg. Weight loss was correlated only with the number of sessions attended (r = 0.53, P < 0.0001). Long-term weight management of obese and overweight patients with severe forms of mental illness was possible through the provision of simple lifestyle advice within the group setting.

Effects of Simvastatin and Metformin on Inflammation and Insulin Resistance in Individuals with Mild Metabolic Syndrome

In addition to lipid-lowering and insulin-sensitizing actions, statins (HMG-CoA reductase inhibitors) and metformin may have pleiotropic effects. To study the effect of simvastatin and metformin on insulin sensitivity and inflammatory markers. Forty-one subjects with body mass index (BMI) 25-39.9 kg/m(2) and impaired glucose tolerance were randomized to receive simvastatin or metformin for 16 weeks. Blood samples were obtained for measurement of metabolic and inflammatory parameters before and after each treatment. As expected, when compared with simvastatin, metformin therapy resulted in significant reductions in mean BMI, fasting plasma glucose, and homeostasis model assessment-insulin resistance (HOMA-IR), whereas simvastatin treatment resulted in significantly reduced total cholesterol, low-density lipoprotein-cholesterol (LDL-C), and apolipoprotein B levels. Independently of the medication used, significant decreases in C-reactive protein (CRP) and interleukin (IL)-6 were detected from baseline to treatment end. CRP showed a mean reduction of 0.12 +/- 0.04 mg/dL (p = 0.002) over the 16-week intervention period and IL-6 a mean reduction was 0.35 +/- 0.17 pg/mL (p = 0.046). No change was observed in the tumor necrosis factor-alpha levels. Baseline values of CRP and IL-6 and their percentage declines were correlated (r = 0.71 and r = 0.67, respectively; p < 0.001). In simvastatin recipients, no correlation was detected between reductions in CRP or IL-6 and lipids, whereas in metformin recipients, reductions in inflammatory markers were not correlated to BMI and HOMA-IR. Our findings suggest that both metformin and simvastatin have similar beneficial effects on low-grade inflammation, in addition to their classical effects on glucose and lipid metabolism. Moreover, they confirm the importance of treating at-risk individuals even before the precipitation of overt diabetes mellitus or full-blown metabolic syndrome.

Effects of an Educational Intervention on Weight Gain in Patients Treated With Antipsychotics

Increasing numbers of reports have raised concerns about significant increases in weight and adiposity over both short- and long-term treatment in patients treated with antipsychotics (APs). The management of overweight and obesity in patients treated with APs has included pharmacological interventions, dietary suggestions, and behavioral strategies. Nevertheless, current evidence does not support the use of pharmacological management of this specific type of obesity, and only a limited number of studies have been published regarding prevention and treatment of weight gain with other strategies. The aim of this study was to evaluate the effectiveness of an educational intervention (EI) that combines low-calorie diet with increased physical activity to prevent and treat weight gain in patients treated with APs. Data were from 53 subjects whose body mass index (BMI) had increased by more than 7% after starting an AP therapy and who consented to participate in a 12-week educational intervention study aimed at preventing further weight gain and, when possible, at inducing a weight loss. Weight and BMI were measured at baseline (at each of the monthly follow-up visits) and at study completion 12 weeks from entry in the study. Twenty-six patients completed the 12-week program. Completers showed a significant mean body weight decrease of 3.15 kg, with a mean BMI reduction of 1.2 (kg/m) at the end of the 3-month period. Educational intervention can be an important tool for the management of weight increase in patients treated with APs. A larger prospective and controlled study is now needed to confirm our findings.

Treatment of Obese Adolescents with Sibutramine: A Randomized, Double-Blind, Controlled Study

Adolescent obesity is becoming a health problem in both developed and developing countries. Antiobesity drug therapy is not currently indicated for the treatment of adolescent obesity and remains investigational at this time. The aim of this study was to determine the efficacy and safety of sibutramine in obese adolescents. A randomized, double-blind, placebo-controlled trial, enrolling 60 adolescents, aged 14-17 yr, for 6 months was conducted. In the first month, all patients received placebo and a hypocaloric diet plus exercise orientation. For the next 6 months, participants received either sibutramine or placebo. Patients assigned to sibutramine group lost an average of 10.3 +/- 6.6 kg, and patients in placebo group lost 2.4 +/- 2.5 kg (P < 0.001). The mean body mass index reduction was significantly greater in the sibutramine group (3.6 +/- 2.5 kg/m(2)) than in the placebo group (0.9 +/- 0.9 kg/m(2); P < 0.001). No participant withdrew because of adverse events, and no difference in blood pressure or heart rate was noted between groups. There were no changes in echocardiographic parameters. In conclusion, sibutramine plus diet and exercise induced significantly more weight loss in obese adolescents.

Incorporating a Quality of Life and Well-Being Instrument as an Additional Outcome Measure of a Comprehensive Weight Management Program

LEARNING OUTCOME: To understand the value of incorporating a psychosocial indicator with traditional outcome measures for obesity intervention. Traditional outcome measurements for weight management programs have focused on anthropometric changes such as body weight and body fat measures exclusively. The Institute Of Medicine report, Weighing the Options, underlined the importance of monitoring global outcome measures due to the multi-factorial nature of obesity. The Behavioral Modification Weight Management Program at Malcolm Grow Medical Center incorporates principles of sustainable lifestyle changes, healthy attitudes, increased physical activity, healthy food choices, and supportive relationships. Patterned largely after the LEARN® program developed by Kelly Brownell at Yale University, a registered dietitian and a clinical health psychologist conduct the 17 week course. After program completion, clients are encouraged to attend monthly follow-up sessions. The Quality of Life Inventory (QOLI), a comprehensive measure of life and health satisfaction, was incorporated in addition to more traditional outcome measures. Baseline, post-treatment, and quarterly follow-up data were collected for the following: Body Mass Index (BMI), waist to hip ratio, blood pressure, total cholesterol, and QOLI. The dietitian reviewed weekly food and exercise diaries during the program. The clients set weekly goals and perceived adherence to the goals was monitored. Sixty-six participants have completed this program in three separate groups, attending an average of 10 sessions. The mean age was 44 years old and 83 percent were women. Mean reduction in BMI was 1.79; total cholesterol was 16.67 mg/dL; weight loss was 11 lb. Well-being, as measured by the QOLI, improved by an average T-score of 6.66. These physical and psychosocial changes indicated a clinically significant increase in satisfaction with health and quality of life as well as a decreased health risk. Follow-up assessments indicate maintenance of these outcomes. Further research is needed to determine if these positive changes resulted from the content of the program, the frequency of contact, or compliance monitoring techniques utilized by the instructors.