Diabetes Disease Stage Predicts Weight Loss Outcomes with Long‐Term Appetite Suppressants

Objectives: Characterize degree of weight loss with stage of diabetes and describe its effect on cardiovascular disease risk factors in obese patients with and without diabetes. Research Methods and Procedures: Retrospective cohort analysis from patients participating in a long‐term weight management protocol using diet, exercise, behavioral modification, and appetite‐suppressant therapy. Patient groups, with (n = 19) and without diabetes (n = 19) were matched for age, gender, and weight before weight loss therapy. The effect of 12 months of therapy on weight, blood pressure, glycemic control, lipid profile, and medication requirements were tested. Additionally, patients were grouped or staged based upon therapy required for control of diabetes at the beginning of weight loss intervention. Analysis of covariance described relationships between diabetes disease stage and weight loss at 12 months. Results: Nondiabetic patients had greater mean reduction in BMI than the diabetic group (7.98 kg/m² vs. 4.77 kg/m², p < 0.01). A significant linear trend (p < 0.001) for decreasing weight loss with stage of diabetes was observed. Blood pressure, lipid profile, and glycemia improved significantly. The average daily glyburide‐equivalent dose decreased from 9.4 to 3.0 mg (p < 0.01). Discussion: Patients with diabetes lost less weight than similarly obese patients without diabetes. Regardless of differential weight loss between groups, cardiovascular disease risk factors improved. Hypoglycemic medication requirements decreased with weight loss therapy. A predictive relationship may exist between diabetes disease stage before weight loss therapy and future weight loss potential.     

Maintenance of Weight Loss: A Needs Assessment

This study identified facilitators and obstacles to maintenance of weight loss following a very-low-calorie-diet and behavior modification program. A survey was mailed to a random sample of 178 program completers and received a 61% response rate; the most frequent follow-up period was more than 2 years. Twenty-nine percent reported weighing the same (within 10 lbs) or less than the end of their participation in the treatment program (maintainers), while 71% reported their present weight was a mean of 65% higher than their initial weight loss (regainers). Maintainers were significantly more likely to report engaging in regular aerobic exercise, attending a maintenance support group, and confidence in their ability to manage their weight in the future, while regainers were more likely to report stress and motivation as frequent weight management obstacles. Respondents consistently identified the need for low/no cost ongoing support. Maintainers and relapsers reported similar challenges in managing their weight, yet with different results, suggesting the need to identify subgroups for which different post-treatment support options could be applied.     

Amount of Food Group Variety Consumed in the Diet and Long‐Term Weight Loss Maintenance

Objective: Decreases in variety of foods consumed within high‐fat‐dense food groups and increases in variety of foods consumed within low‐fat‐dense food groups are associated with lower energy intake and greater weight loss during obesity treatment and may assist with weight loss maintenance. This study examined food group variety in 2237 weight loss maintainers in the National Weight Control Registry, who had lost 32.2 ± 18.0 kg (70.9 ± 39.5 lbs) and maintained a weight loss of at least 13.6 kg (30 lbs) for 6.1 ± 7.7 years. Research Methods and Procedures: At entry into the registry, registry members completed a food frequency questionnaire from which amount of variety consumed from different food groups was assessed. To provide a context for interpreting the level of variety occurring in the diet of registry participants, food group variety was compared between registry participants and 96 individuals who had recently participated in a behavioral weight loss program and had lost at least 7% of initial body weight. Results: Registry members reported consuming a diet with very low variety in all food groups, especially in those food groups higher in fat density. Registry participants consumed significantly (p < 0.001) less variety within all food groups, except fruit and combination foods, than recent weight losers after 6 months of weight loss treatment. Discussion: These results suggest that successful weight loss maintainers consume a diet with limited variety in all food groups. Restricting variety within all food groups may help with consuming a low‐energy diet and maintaining long‐term weight loss.     

Topiramate: Long‐Term Maintenance of Weight Loss Induced by a Low‐Calorie Diet in Obese Subjects

Objective: To examine the safety and efficacy of topiramate (TPM) for maintaining weight following a low‐calorie diet. Research Methods and Procedures: Obese subjects (30 ≤ BMI < 50 kg/m²) 18 to 75 years old received a low‐calorie diet for 8 weeks. Those who lost ≥8% of their initial weight received TPM (96 or 192 mg/d) or placebo; all were on a lifestyle modification plan. Sixty weeks of medication were planned. Sponsor ended study early to develop a new controlled‐release formulation with the potential to enhance tolerability and simplify dosing in this patient population. Efficacy was analyzed in subjects who completed 44 weeks of treatment before study termination. Results: Of the 701 subjects enrolled, 80% lost ≥8% of their initial body weight and were randomized; 293 were analyzed for efficacy. Most withdrawals were due to premature termination of the study. Subjects receiving TPM lost 15.4% (96 mg/d) and 16.5% (192 mg/d) of their enrollment weight by week 44, compared with 8.9% in the placebo group (p < 0.001). Subjects on TPM continued to lose weight after the run‐in, whereas those on placebo regained weight. Significantly more TPM subjects lost 5%, 10%, or 15% of their randomization weight than placebo. Most adverse events were related to the central nervous system. Discussion: During a treatment period of 44 weeks, TPM was generally well tolerated, and subjects maintained weight loss initially achieved by a low‐calorie diet—and produced additional clinically significant weight loss beyond that achieved by a low‐calorie diet.     

Metabolic and Weight Loss Effects of Long‐Term Dietary Intervention in Obese Patients: Four‐Year Results

Objective: To investigate the contribution of meal and snack replacements for long‐term weight maintenance and risk factor reduction in obese patients. Research Methods and Procedures: Prospective, randomized, two‐arm, parallel intervention for 12 weeks followed by a prospective single‐arm 4‐year trial in a University Hospital clinic. One hundred patients, >18 years old and with a body mass index > 25 and ≤ 40 kg/m², were prescribed a 1200 to 1500 kcal/d control diet (Group A) or an isoenergetic diet, including two meal and snack replacements (vitamin‐ and mineral‐fortified shakes, soups, and bars) and one meal high in fruits and vegetables (Group B). Following a 3 months of weight loss, all patients were prescribed the same energy‐restricted diet (1200 to 1500 kcal) with one meal and one snack replacement for an additional 4 years. Results: All 100 patients were evaluated at 12 weeks. Mean percentage weight loss was 1.5 ± 0.4% and 7.8 ± 0.5% (mean ± SEM) for Groups A and B, respectively. At 12 weeks systolic blood pressure, plasma triacylglycerol, glucose, and insulin concentrations were significantly reduced in Group B, whereas no changes occurred in Group A. After 4 years, 75% of the patients were evaluated. Total mean weight loss was 3.2 ± 0.8% for Group A and 8.4 ± 0.8% (mean ± SEM) for Group B. Both groups showed significant improvement in blood glucose and insulin (p < 0.001), but only Group B showed significant improvement in triacylglycerol and systolic blood pressure compared to baseline values (p < 0.001). Discussion: Providing a structured meal plan via vitamin‐ and mineral‐fortified liquid meal replacements is a safe and effective dietary strategy for obese patients. Long‐term maintenance of weight loss with meal replacements can improve certain biomarkers of disease risk.     

Short‐Term Effects of Weight Loss on the Cardiovascular Risk Factors in Morbidly Obese Patients

Objective: To analyze the short‐term effects of weight loss on the cardiovascular risk factors in morbidly obese patients. Research Methods and Procedures: Five metabolic cardiovascular risk factors (blood glucose, blood pressure, total cholesterol, high‐density lipoprotein (HDL)‐cholesterol, and triglycerides) were determined before and 15.3 ± 2.1 months after laparoscopic gastric banding in 650 morbidly obese patients. Global cardiovascular risk was calculated according to the Prospective Cardiovascular Münster (PROCAM) scoring system. Results: Mean weight loss was 22.7 ± 20.4 kg. Normalization of the metabolic alteration was observed in 67.3% of patients with diabetes, 38.3% of patients with hypercholesterolemia, 72.5% of patients with low HDL‐cholesterol, 72.3% of patients with hypertriglyceridemia, and 46.7% of patients with hypertension. PROCAM score fell from 31.4 ± 11.6 to 28.0 ± 12.0 points (p < 0.001). The modifications of total cholesterol and blood pressure were unrelated to percentage weight loss. Percentage weight loss was significantly related to the reductions of fasting blood glucose, triglyceride level, and the PROCAM score and to the increase of HDL‐cholesterol concentrations observed after surgery. However, the strength of these four relationships was generally low. The variations of HDL‐cholesterol concentrations and blood pressure levels were more influenced by actual energy balance than by the extent of weight loss. Discussion: Weight loss observed in the first 12 to 18 months after gastric banding was associated with a significant improvement of single cardiovascular risk factors and global risk. On the other hand, the extent of weight loss was poorly related to the magnitude of improvement in cardiovascular risk.     

Predictors of Long‐term Weight Maintenance

Objective: The purpose of this study was to evaluate available variables of a long‐term weight maintenance study to investigate possible factors predisposing to weight regain after a period of weight loss. Research Methods and Procedures: The Maastricht Weight Maintenance Study is an ongoing longitudinal study of healthy men and women (29 men and 62 women; 18 to 65 years of age; BMI = 30.2 ± 3.1 kg/m²). A variety of parameters were measured before and after a very‐low‐energy diet and after a follow‐up of at least 2 years. Results: Mean weight loss was 7.9 ± 3.6 kg, and percent weight regain was 113.8 ± 98.1%. Percent BMI regain was negatively associated with an increase in dietary restraint (r = ?0.47, p < 0.05). Percent weight regain was negatively correlated with baseline resting metabolic rate (r = ?0.38, p = 0.01) and baseline fat mass (r = ?0.24, p = 0.05) and positively correlated with the magnitude of change in body weight (BW) expressed as maximum amplitude of BW (r = 0.21, p < 0.05). In addition, amplitude of BW was positively correlated with the frequency of dieting (r = 0.57, p < 0.01). Discussion: The best predictors for weight maintenance after weight loss were an increase in dietary restraint during weight loss, a high baseline resting metabolic rate, a relatively high baseline fat mass favoring a fat‐free mass–sparing effect during weight loss, a rather stable BW, and a low frequency of dieting. Therefore, BW maintenance after BW loss seems to be a multifactorial issue, including mechanisms that regulate an individuals’ energy expenditure, body composition, and eating behavior in such a way that energy homeostasis is maintained.     

Physical Activity and Long-Term Maintenance of Weight Loss

To examine the effect of exercise on the long-term maintenance of weight loss, two types of literature were reviewed - correlational studies of predictors of long-term weight loss, and randomized trials comparing diet, exercise, and the combination of diet plus exercise. Both literatures were striking in the consistency with which activity emerged as a determinant of long-term maintenance of weight loss. The benefits of exercise for long-term weight maintenance were observed with different types of populations, diets, and exercise interventions. Several possible explanations for these positive effects of diet plus exercise are presented, and suggestions made for future research on ways to maximize the benefit of this approach to weight control. Since adherence to exercise may ultimately prove to be the cornerstone for long-term weight maintenance, studying ways to improve exercise adherence is recommended.     

Relationship of Co-Morbidities of Obesity to Weight Loss and Four-Year Weight Maintenance/Rebound

This study examined the effect of weight loss (separate from energy restriction) and weight maintenance/rebound over time on blood pressure, serum lipids, and body composition in 24 obese (mean 137% ideal body weight (IEW)) females with mild to moderate hypertension. Weight loss was induced under tightly controlled General Clinical Research Center conditions until each subject had lost at least 10 kg (mean 13 kg) and attained normal body weight (<120% IBW). After 4 years subjects returned for repeat evaluation. Weight changes were compared with 24 pair-matched normal weight controls who were also followed for 4 years. With weight loss, significant improvements were seen in standing mean arterial pressure (MAP), serum total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Subjects regained 11 kg (87% of the weight lost) over the 4 year follow-up period while control subjects gained only 2 kg. Subjects who chose self-selected exercise gained less weight than nonexercisers (6 kg vs. 13 kg, P<0.05). With weight regain there were significant increases in standing and supine MAP, total cholesterol, and high-density lipoprotein (HDL) cholesterol. The amount of weight regained was significantly correlated with standing MAP (r=0.73), triglycerides (r=0.43), and HDL cholesterol (r=-0.47). The percentage fat of the weight regained was no greater than that of the weight previously lost. Weight loss, distinct from energy restriction, was associated with improvements in blood pressure and serum lipid levels. The ability to sustain these improvements in the co-morbidities of obesity was directly related to the persistence and magnitude of weight loss maintenance.     

Effort‐Related Calf Pain in the Obese and Long‐Term Changes after Surgical Obesity Treatment**

Objective: To compare the prevalence of effort‐related calf pain in an obese and a general population and to analyze the incidence of and recovery from such pain after surgical and conventional obesity treatment. Research Methods and Procedures: A random sample of 1135 subjects from a general population was compared with 6328 obese subjects in the Swedish Obese Subjects study. Obese subjects were followed longitudinally, and information about calf pain was obtained from surgically and conventionally treated patients for up to 6 years. Results: In both sexes, self‐reported calf pain was more common in the obese than in the general population [odds ratios (ORs) 5.0 and 4.0 in men and women, respectively, p < 0.001]. Obese patients undergoing surgery had a lower 6‐year incidence of calf pain compared with the conventionally treated control group (ORs 0.39 and 0.61, p < 0.05). Among subjects reporting symptoms at baseline, the 6‐year recovery rate was higher in the surgical group compared with the control group (ORs 15.3 and 5.9, p < 0.001). Discussion: Obese subjects have markedly more problems with effort‐related calf pain than the general population. Surgical obesity treatment reduces the long‐term risk of developing claudication symptoms and increases the likelihood of recovering from such symptoms.     

The Long‐Term Management of Obesity with Continuing Pharmacotherapy

Objective: Long‐term, possibly lifetime, use of medications for the management of obesity may be thought to be similar to the use of pharmacotherapy for other chronic diseases such as hypertension or diabetes. Because there have been no systematic studies of this extended use, the experience of eight patients who have used obesity medications in a sustaining manner was studied. Research Methods and Procedures: The clinical characteristics of eight adult patients, each of whom has experience with long‐term (more than 10 years) use of medications for weight loss and weight maintenance, were studied. Results: The clinical experience of these eight patients was analyzed. Each chose to sustain the use of weight management medications for more than 10 years because of perceived benefit, comfort, and the absence of significant side effects. There has been no evidence of the development of tolerance, addiction, or misuse and no adverse events related to the medication. The beneficial effects of the medication have not diminished with time. Discussion: The clinical characteristics of eight patients, each of whom has used obesity pharmacotherapy for more than 10 years, are described. The experience of these eight individuals cannot be generalized to the entire population of overweight or obese patients. It does suggest, however, that some patients respond successfully to this form of therapy and that they will derive value from it for the management of this disease. Efforts should be made to identify these patients, and consideration should be given to the use of chronic medications for the continuing management of obesity.     

Effects of a Personal Trainer and Financial Incentives on Exercise Adherence in Overweight Women in a Behavioral Weight Loss Program

Exercise is important for long-term weight loss, but few studies have examined ways to improve exercise adherence in overweight subjects participating in a behavioral weight loss program. This paper presents two studies, one conducted at the University of Pittsburgh and one at the University of Minnesota, that sought to improve exercise adherence by exerting more direct control over the environmental antecedents and consequences controlling exercise. Study 1 investigated the use of a personal trainer who called participants regularly and met them at their home or office at scheduled times for a walk. Study 2 investigated the effect of a lottery incentive for exercise adherence. In both studies, the effect of these manipulations was examined in the context of a 24-week standard behavioral weight control program with three supervised exercise sessions per week. Neither intervention achieved statistically significant improvements in exercise adherence compared to control conditions, perhaps due in part to the limited statistical power of the studies. Future studies should focus on better understanding the barriers to exercise and designing behavioral interventions that address these barriers.     

Population‐based Study of Trends,Costs, and Complications of Weight Loss Surgeries from 1990 to 2002

Objective: To describe the trends, costs, and complications associated with weight loss surgery (WLS). Research Methods and Procedures: Wisconsin inpatient hospital discharge data from 1990 to 2003 were used for analysis. A WLS case was defined as anyone with a WLS‐related procedure code and a primary diagnosis of morbid obesity. Charges were inflation‐adjusted to 2001 constant dollars; complications were defined on the basis of readmission, extended length of stay, repeat surgical procedures, or death. Results: The number of WLSs increased from 269 in 1990 to 1992 to 1884 in 2000 to 2002 (rate ratio = 4.6). Increases in WLSs were greatest among those 50 to 59 years of age (rate ratio = 6.4), women (rate ratio = 6.8), and blacks (rate ratio = 20.0). Between the two periods, inflation‐adjusted WLS charges increased 12‐fold, and the inflation‐adjusted charge per procedure doubled, despite a decreased length of stay. For 2000 to 2002, 23.3% of WLS patients had either an extended length of stay or readmission within 30 days, 7.4% required a repeat surgical procedure, and 0.7% died. Discussion: In Wisconsin, the rate and costs of WLSs have increased dramatically, and the incidence of postoperative complications was high. The epidemic of obesity in the United States makes it imperative to better assess the cost‐effectiveness of WLS and to improve its safety.     

Gender Differences in the Response of Plasma Leptin Concentrations to Weight Loss in Obese Older Individuals

Plasma leptin concentration is directly related to the degree of obesity and is higher in women than in men of the same body mass index (BMI). We hypothesized that fasting plasma leptin concentrations and the response of leptin to weight loss would differ in older men and women of a similar fat mass. Plasma leptin concentrations (radioimmunoassay) and fat mass (DXA) were measured in 47 older, obese (BMI=30 ± 4 kg/m²) women and 23 older, obese (BMI=31 ± 3 kg/m²) men after a 2 to 4 week period of weight and dietary stabilization, and then in 22 of the women and 18 of the men after a 6-month weight loss intervention (250–350 kcal/d deficit). Leptin correlated with fat mass in men and women (r=0.75 and r=0.77, respectively; p values<0.0001), but women had 3-fold higher leptin levels for a given fat mass than men (p=0.01). In response to the 6-month hypocaloric diet, men and women lost a similar percentage of fat mass (?13% and ?16%, respectively), but the relative decline in circulating leptin was greater in women than men (-45% and ?21%, respectively; p<0.0001). In addition, when leptin was normalized for fat mass using the ratio method, the decrease in leptin per kilogram of fat mass was greater in women than men (-0.37 ± 0.34 vs. ?0.04 ± 0.06 ng/mL/kg; p<0.01). After weight loss, the change in leptin concentrations correlated positively with the change in fat mass in men (r=0.60; p<0.01), but not in women (r=0.31; p=0.17). Furthermore, the loss in fat mass correlated negatively with baseline leptin levels in women (r=-0.47; p<0.05), but not in men (r=0.03, p=NS). These results indicate that the decline in leptin concentration with weight loss correlates with the loss in fat mass in men; but, in women, other factors affect the decrease in leptin concentration. This suggests that the role of leptin in the regulation of obesity is gender-specific and may account for gender differences in response to hypocaloric treatment and maintenance of lost weight.     

Effect of Degree of Weight Loss on Health Benefits

Although most dieters strive to achieve “ideal” body weight, clinical and laboratory evidence clearly supports the value of a modest weight loss goalto attain health and emotional benefit. Weight loss as low as 5% has been shown to reduce or eliminate disorders associated with obesity, though several questions remain partially or completely unanswered regarding the roles of degree of weight loss, method of weight loss, distribution of fat reduction, and other variables. This paper reviews the effect of degree of weight loss on specific disease states and risk factors and discusses the impact of ethnic background at distribution, age, and mode of weight loss on outcome.     

Provision of Foods Differing in Energy Density Affects Long‐Term Weight Loss

Objective: The energy density (kilocalories per gram) of foods influences short‐term energy intake. This 1‐year clinical trial tested the effect on weight loss of a diet incorporating one or two servings per day of foods equal in energy but differing in energy density. Research Methods and Procedures: Dietitians instructed 200 overweight and obese women and men to follow an exchange‐based energy‐restricted diet. Additionally, subjects were randomized to consume daily either one or two servings of low energy‐dense soup, two servings of high energy‐dense snack foods, or no special food (comparison group). Results: All four groups showed significant weight loss at 6 months that was well maintained at 12 months. The magnitude of weight loss, however, differed by group (p = 0.006). At 1 year, weight loss in the comparison (8.1 ± 1.1 kg) and two‐soup (7.2 ± 0.9 kg) groups was significantly greater than that in the two‐snack group (4.8 ± 0.7 kg); weight loss in the one‐soup group (6.1 ± 1.1 kg) did not differ significantly from other groups. Weight loss was significantly correlated with the decrease in dietary energy density from baseline at 1 and 2 months (p = 0.0001) but not at 6 and 12 months. Discussion: On an energy‐restricted diet, consuming two servings of low energy‐dense soup daily led to 50% greater weight loss than consuming the same amount of energy as high energy‐dense snack food. Regularly consuming foods that are low in energy density can be an effective strategy for weight management.     

Comparison of Obese NIDDM and Nondiabetic Women: Short- and Long-Term Weight Loss

Previous research suggests that overweight patients with diabetes lose less weight than non diabetics. We compared the response of obese women with NIDDM to non diabetic controls, matched for age and weight, to a behavior weight loss program. Forty-three overweight women (20 NIDDM, 23 non diabetic) participated in the study. NIDDM and non diabetic subjects were treated together and received the same 16-week behavioral weight loss program. Dependent measures included weight, 3-day food records, physical activity, fasting plasma glucose, and questionnaires assessing eating behavior and depressive symptomatology. Weight loss of NIDDM and non diabetic subjects at posttreatment was comparable (-7.4 ± 5.3 kg vs. ?6.4 ± 3.8 kg, respectively). Changes in caloric intake, eating behavior, exercise and depressive symptomatology were also similar between the two groups. However, during the 1-year follow-up period, NIDDM subjects regained 5.4 ± 6.1 kg compared to 1.0 ± 6.7 kg for nondiabetics (p=.058). These data indicate that NIDDM subjects can lose as much weight as their nondiabetic peers during active treatment Once treatment terminated, however, NIDDM subjects demonstrated poor weight loss maintenance. Thus the added motivation that comes from having diabetes and seeing improvements in glycemic control with weight loss were not sufficient to improve long term weight loss in diabetic subjects. A continuous care model of weight control may be particularly necessary for overweight patients with type II diabetes.     

Weight Loss Expectations in Patients with Binge‐Eating Disorder

Objective: To study weight loss expectations in patients with binge‐eating disorder and to examine whether expectations differed by sex and motivation for treatment. Research Methods and Procedures: One hundred and thirty patients (104 women and 26 men), aged 23 to 61 (mean age, 43.0 years), with BED completed a measure of desired weights that included their dream weight, happy weight, acceptable weight, and disappointed weight. In a structured interview, participants were asked their primary motivation for seeking treatment (appearance or health) and their lowest adult weight (LAW). Results: The BED participants reported weight loss expectations that far exceeded expert and governmental guidelines. In this sample, desired dream body mass index (BMI), happy BMI, and acceptable BMI averaged reductions in current weight of 36%, 29%, and 23%, respectively. Even the “disappointed” BMI was an average 14% reduction in current weight, and was 1.5 to 3 times greater than the expert recommendation (5% to 10%). Comparisons of desired weights were significantly different for women and men, whereas percent reductions from current weight were not. Although weight goal expectations were significantly lower for those motivated by appearance, compared with those motivated by health, percent reductions for current weight were not. Desired dream weight correlated with reported LAW, and the mean difference between these weights was not significant. Discussion: These findings suggest that patients with BED have weight loss expectations that far exceed expert and governmental guidelines and that these expectations do not differ by sex or motivation for seeking treatment. One possible explanation for these unrealistic desired weights may be the patients’ recollections of their LAWs.     

Targeting Parents Exclusively in the Treatment of Childhood Obesity: Long‐Term Results

Objective: To report the long‐term change in children's overweight following a family‐based health‐centered approach where only parents were targeted compared with a control intervention where only children were targeted. Research Methods and Procedures: Fifty of the 60 children who participated in the original study were located 7 years later, and their weight and height were measured. At the point of the 7‐year follow‐up, the children were 14 to 19 years of age. Repeated measure ANOVA was used to test differences between the groups in percent overweight at different time‐points. Results: Mean reduction in percent overweight was greater at all follow‐up points in children of the parent‐only group compared with those in the children‐only group (p < 0.05). Seven years after the program terminated, mean reduction in children's overweight was 29% in the parent‐only group vs. 20.2% in the children‐only group (p < 0.05). Discussion: Over the long term, treatment of childhood obesity with the parents as the exclusive agents of change was superior to the conventional approach.