The relationship between early weight loss and weight loss at 1 year with naltrexone ER/bupropion ER combination therapy.

BACKGROUND/OBJECTIVES: Weight management medications increase the likelihood that patients will achieve clinically meaningful improvements in cardiovascular, metabolic and other weight-related measures of health. However, the weight loss achieved with any weight management intervention can vary widely among individuals, and patients who do not respond to pharmacotherapy by achieving clinically meaningful weight loss should discontinue therapy. We characterized 1-year weight loss in the phase 3 clinical trial program of the weight management medication, naltrexone/bupropion 32/360 mg (NB), as well as the relationship between early weight loss and long-term weight loss, particularly with respect to participants who achieved the clinically recommended threshold of ⩾5% weight loss by Week 16. PARTICIPANTS/METHODS: Data from participants from each of the four phase 3, randomized, placebo-controlled, 56-week clinical trials with NB were pooled (modified intent-to-treat population; NB N=2043, Placebo N=1319). This exploratory analysis examined the relationship between participant achievement of various weight loss thresholds early in treatment (at Week 8, 12 or 16) and the associated weight loss at Week 56 (Completers population; NB N=1310, Placebo N=763). RESULTS: In the NB participants who completed 1 year of treatment, weight loss of at least 5% at Week 16 (n=873) was associated with least-squares mean weight loss of 11.7% at Week 56 and 85% of these participants had Week 56 weight loss of ⩾5%. Eighty percent (95% confidence interval: 78-82%) of the participants who would, and would not, achieve ⩾5% weight loss at Week 56 were correctly identified using the clinically recommended threshold of ⩾5% at Week 16. Safety and tolerability of NB was similar to previously published reports. CONCLUSIONS: Participants who meet the Week 16 threshold of ⩾5% weight loss are likely to maintain clinically significant weight loss after 1 year of treatment. Further evaluations are required to evaluate improvements in measures of cardiovascular and metabolic risk.

Factors associated with development of excessive fatness in children and adolescents: a review of prospective studies.

The purpose of this review was to examine the factors that predict the development of excessive fatness in children and adolescents. Medline, Web of Science and PubMed were searched to identify prospective cohort studies that evaluated the association between several variables (e.g. physical activity, sedentary behaviour, dietary intake and genetic, physiological, social cognitive, family and peer, school and community factors) and the development of excessive fatness in children and adolescents (5-18 years). Sixty-one studies met the eligibility criteria and were included. There is evidence to support the association between genetic factors and low physical activity with excessive fatness in children and adolescents. Current studies yielded mixed evidence for the contribution of sedentary behaviour, dietary intake, physiological biomarkers, family factors and the community physical activity environment. No conclusions could be drawn about social cognitive factors, peer factors, school nutrition and physical activity environments, and the community nutrition environment. There is a dearth of longitudinal evidence that examines specific factors contributing to the development of excessive fatness in childhood and adolescence. Given that childhood obesity is a worldwide public health concern, the field can benefit from large-scale, long-term prospective studies that use state-of-the-art measures in a diverse sample of children and adolescents.

Remission of metabolic syndrome following a 15-week low-calorie lifestyle change program for weight loss.

OBJECTIVE: To evaluate the rate of remission of metabolic syndrome (Met Syn) among patients undergoing a brief, low-calorie lifestyle change weight loss intervention and to compare the baseline characteristics of patients who were remitted and not remitted from Met Syn at post-treatment. RESEARCH METHODS AND PROCEDURES: Obese adults (N=36) meeting criteria for Met Syn enrolled in an outpatient fee-for-service behavioral weight loss intervention. Participants were assessed on key Met Syn variables (waist circumference, blood pressure, triglycerides, high-density lipoprotein (HDL) cholesterol and fasting blood glucose) at pre- and post-treatment. RESULTS: The majority of patients (61%) responded to treatment after a 9.9% mean weight loss. Although Met Syn responders did not differ significantly from Met Syn non-responders on any baseline Met Syn criterion variable, responders had significantly lower baseline body mass indices (BMI; kg/m(2)) and met criteria for fewer baseline Met Syn variables. As expected, Met Syn responders, compared with Met Syn non-responders, had significantly lower post-treatment waist circumference, systolic and diastolic blood pressures, triglycerides and fasting blood glucose. Patient groups did not differ significantly on weight lost (kg or %), or on the proportion of patients losing > or =10% of initial body weight. DISCUSSION: In a community population, Met Syn responds to weight loss through a low-calorie lifestyle intervention; for some patients, however, the recommended 10% weight loss may not be enough for Met Syn remission.

Utility and validity of the eating behavior inventory in clinical obesity research: a review of the literature.

The Eating Behavior Inventory (EBI) is a questionnaire designed to assess behaviours associated with weight loss and weight management. In the 25 years since it was first published, the EBI has been used to examine weight management behaviours of adults and children in more than 20 weight loss investigations. This paper systematically reviews the use of the EBI in these studies. Results indicate that baseline EBI scores have remained quite consistent over time and are generally not influenced by patient variables. The EBI has also been shown to be consistently sensitive to behavioural weight management interventions, but it appears that the amount of change in EBI scores has decreased slightly over time. Finally, the amount of change in EBI score with treatment typically correlates positively with the amount of weight subjects lose. Overall, the research that has used the EBI has provided solid and consistent evidence of the utility of the EBI as a valid tool for assessing weight management behaviours.

Night eating syndrome: effects of brief relaxation training on stress, mood, hunger, and eating patterns.

BACKGROUND: Night eating syndrome (NES) is characterized by a lack of appetite in the morning, consumption of 50% or more of daily food intake after 6:00 p.m., and difficulty falling and/or staying asleep. It has been associated with stress and with poor results at attempts to lose weight. OBJECTIVE: The purpose of this study was to determine whether a relaxation intervention (Abbreviated Progressive Muscle Relaxation Therapy, APRT) that has been shown to significantly reduce stress levels in normal, healthy adults would also benefit an NES sample. RESEARCH METHODS AND PROCEDURES: A total of 20 adults with NES were randomly assigned to either a relaxation training (APRT) or a Control (quietly sitting for the same amount of time) group, and all subjects attended two laboratory sessions 1 week apart. Pre- and postsession indices of stress, anxiety, relaxation, and salivary cortisol were obtained, as well as Day 1 and Day 8 indices of mood. Food diaries and hunger ratings were also obtained. RESULTS: The results indicated that 20 min of a muscle relaxation exercise significantly reduced stress, anxiety, and salivary cortisol immediately postsession. After practicing these exercises daily for a week, subjects exhibited lowered stress, anxiety, fatigue, anger, and depression on Day 8. APRT was also associated with significantly higher a.m. and lower p.m. ratings of hunger, and a trend of both more breakfast and less night-time eating. DISCUSSION: These data support the role of stress and anxiety in NES and suggest that practicing relaxation may be an important component of treatment for this condition.

Assessing dietary intake in the management of obesity.

This paper focuses on assessing the caloric-intake side of the energy balance equation in clinical settings. In the treatment of obesity, dietary assessment may have many purposes including the following: 1) establishing a baseline of eating patterns to determine targets of intervention and to gauge progress, 2) providing a means of monitoring change in the targeted dietary areas and behaviors, and 3) allowing for ongoing feedback to the patient. The types of data to be gathered in dietary assessment will depend on the purposes of the assessment. The nature, advantages, and disadvantages of the following dietary assessment methods are reviewed: 24-hour recall, diet history interview and questionnaire, and self-monitoring. When used on an ongoing basis in treatment, self-monitoring enhances weight-loss outcomes. However, compliance with self-monitoring varies widely across patients and over time. Possible methods of increasing compliance are discussed. Recent technological advances in software and hardware systems offer promise in improving compliance and effectiveness of self-monitoring.

Which comes first in the pathogenesis of bulimia nervosa: dieting or bingeing?

OBJECTIVE: Clinical experience has indicated that dieting usually precedes the onset of binge eating in the development of bulimia nervosa (BN). However, data confirming this in nonclinical, representative samples are lacking. METHOD: Using results obtained from the National Women's Study (NWS), we were able to determine the chronological relationship between age of onset of significant dieting (attempting to lose 15 lbs) and onset of bingeing in 85 respondents who met DSM-III-R criteria for BN. These respondents were a subset of over 3,000 female adult U.S. women who completed a random telephone interview (averaging 40 min and including screenings for rape, sexual molestation, aggravated assault, posttraumatic stress disorder [PTSD], and BN). RESULTS: We found that the age of first serious attempt to diet preceded the age of first binge in 46% of cases. There were no significant differences in histories of victimization experiences among the groups. First binge preceded first serious diet in 37% of cases, and these behaviors occurred during the same age in 17% of cases. DISCUSSION: These data confirm that dieting is more likely to precede binge eating, although binge eating precedes significant dieting in a substantial proportion of bulimic respondents.

The perceived relative worth of reaching and maintaining goal weight.

OBJECTIVE: To examine the perceived relative worth of reaching and maintaining a self-selected goal weight, for obese and non-obese individuals. DESIGN: Cross-sectional study. SUBJECTS: Twenty-five obese treatment-seekers (age 41.0 y, BMI 42.5) and a community sample of 31 obese (age 40.8 y, BMI 32.2) and 64 non-obese participants (age 32.4 y, BMI 23.4). MEASUREMENT: An 18-item forced-choice questionnaire evaluating what participants would hypothetically sacrifice to reach and maintain their goal weight. RESULTS: Most obese treatment-seekers would hypothetically endure much to achieve their desired weight. For example, 88% or more would forego a job promotion, retiring with full-pay, eliminating the national debt, or winning their dream house or car or an all-expense-paid vacation, and smaller majorities would suffer loss of half their income or a job demotion. Many non-treatment-seeking obese would forfeit future rewards to reach goal weight, but fewer would incur negative events. About a third of non-obese participants would forgo certain positive events, but few would suffer an adverse event to achieve goal weight. Within the combined obese sample, females viewed attaining goal weight as more important than did males, but there were no significant racial differences. An index of overall worth of weight goal was related positively to current weight and BMI and negatively to goal weight as percentage of current weight (P<0.01). CONCLUSION: Excessive value may be placed on attaining less than realistic weight goals, particularly but not exclusively by treatment-seeking and heavier obese people and those who desire greater weight loss. Clinicians should take this phenomenon into consideration, and public health initiatives should attempt to place body weight in a more balanced perspective.

Short-term impact of a church-based approach to lifestyle change on cardiovascular risk in African Americans.

While lifestyle modification decreases cardiovascular risk, there are barriers to lifestyle education in usual clinical practice, especially among the medically underserved. To address this gap, "Lighten Up," a church-based lifestyle program was developed in collaboration with the local African-American Christian community. Lighten Up includes a baseline health assessment (week 1), eight educational sessions (weeks 2-9) combining study of scripture and a health message, a short-term health check (week 10) and a long-term health check (week 52). Baseline and 10 week risk factor data have been obtained in 133 African Americans from eight sites (83% women) and form the basis of this report. At baseline, 76% of participants had two or more modifiable risk factors (overweight, hypertension, borderline high cholesterol, or diabetes). The entire group had significant short-term reductions in weight (-2.3 pounds, P<.01), mean blood pressure (BP, -2.1 mm Hg, P<.05), and triglycerides (-11 mg/dl, P<.05). Risk factor improvement was greater among the 60 subjects who attended 75% or more of the educational sessions. In this group, weight fell 2.9+/-0.6 pounds (mean +/- SEM; P<.01), mean BP declined 3.8+/-1.2 mm Hg (P<.01), total cholesterol was lowered 6+/-4 mg/ dl (P = .12), and triglycerides were reduced 17+/-9 mg/dl (P = .05). Lighten Up is reaching a group with multiple cardiovascular risk factors that is not optimally managed by existing healthcare resources. Of the 133 participants, 70% attended half or more of the sessions, and several components of the risk factor cluster were favorably affected.

A prospective study of holiday weight gain.

BACKGROUND: It is commonly asserted that the average American gains 5 lb (2.3 kg) or more over the holiday period between Thanksgiving and New Year's Day, yet few data support this statement. METHODS: To estimate actual holiday-related weight variation, we measured body weight in a convenience sample of 195 adults. The subjects were weighed four times at intervals of six to eight weeks, so that weight change was determined for three periods: preholiday (from late September or early October to mid-November), holiday (from mid-November to early or mid-January), and postholiday (from early or mid-January to late February or early March). A final measurement of body weight was obtained in 165 subjects the following September or October. Data on other vital signs and self-reported health measures were obtained from the patients in order to mask the main outcome of interest. RESULTS: The mean (+/-SD) weight increased significantly during the holiday period (gain, 0.37+/-1.52 kg; P<0.001), but not during the preholiday period (gain, 0.18+/-1.49 kg; P=0.09) or the postholiday period (loss, 0.07+/-1.14 kg; P=0.36). As compared with their weight in late September or early October, the study subjects had an average net weight gain of 0.48+/-2.22 kg in late February or March (P=0.003). Between February or March and the next September or early October, there was no significant additional change in weight (gain, 0.21 kg+/-2.3 kg; P=0.13) for the 165 participants who returned for follow-up. CONCLUSIONS: The average holiday weight gain is less than commonly asserted. Since this gain is not reversed during the spring or summer months, the net 0.48-kg weight gain in the fall and winter probably contributes to the increase in body weight that frequently occurs during adulthood.

Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study.

BACKGROUND: Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment. OBJECTIVE: This multicenter, double-blind, placebo-controlled study was designed to test the hypothesis that orlistat, a gastrointestinal lipase inhibitor, is significantly more effective than a placebo in preventing weight regain. DESIGN: Obese subjects who lost > or = 8% of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet (4180-kJ/d deficit) with no adjunctive pharmacotherapy were randomly assigned to receive placebo, 30 mg orlistat, 60 mg orlistat, or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain. Of 1313 recruited subjects [body mass index (in kg/m2): 28-43], 729 subjects lost > or =8% of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase. RESULTS: After 1 y, subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects (32.8 +/- 4.5% compared with 58.7 +/- 5.8% regain of lost weight; P < 0.001). Moreover, more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25% of lost weight (47.5% of subjects compared with 29.9%). In addition, orlistat treatment (120 mg 3 times daily) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo (P < 0.001). CONCLUSION: The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors.

Cognitive appraisals of dietary transgressions by obese women: associations with self-reported eating behavior, depression, and actual weight loss.

OBJECTIVE: To identify three groups of obese people entering weight loss treatment, who have distinctly different cognitive appraisals of dietary transgressions and to compare these groups on self-report inventories of eating patterns, dieting, and depression, as well as on treatment completion rates and weight loss. DESIGN: Retrospective review of clinical records. Using a measure which evaluates eating-related cognitive appraisals, participants were categorized into one of three cognitive groups (All-or-None, Rationalization, Matter-of-Degree). SUBJECTS: 289 treatment-seeking obese women (age: 40.9 y, body mass index (BMI): 34.7 kg/m2). MEASUREMENTS: Self-reported eating and dieting behavior (Three-Factor Eating Questionnaire and Eating Behavior Inventory); depression (Beck Depression Inventory); attendance information and body weight obtained during treatment. RESULTS: The cognitive group representing objective thinkers (Matter-of-Degree) reported significantly fewer problems with overeating and more personal control over eating than did the rigid, dichotomous thinkers (All-or-None). In addition, the Matter-of-Degree (MAT) group endorsed significantly less subjective hunger and fewer depressive symptoms than the other two cognitive groups. The Rationalization group was more likely to complete a treatment program than was the All-or-None group, with the MAT group not differing from either. Despite these findings, there were no significant differences among cognitive groups on total weight loss. CONCLUSIONS: Cognitive appraisals of weight-control lapses appear to be associated with self-reported eating behavior, depressive symptoms and treatment completion rates, but not with treatment-induced weight loss. The relationship between long-term weight loss and cognitive appraisals of dieting lapses is yet to be determined. It appears necessary to assess empirically the validity of assumptions regarding factors associated with treatment outcome.

The body mass index-mortality relationship in white and African American women.

OBJECTIVE: To examine the association of body mass index to all-cause and cardiovascular disease (CVD) mortality in white and African American women. RESEARCH METHODS AND PROCEDURES: Women who were members of the American Cancer Society Prevention Study I were examined in 1959 to 1960 and then followed 12 years for vital status. Data for this analysis were from 8,142 black and 100,000 white women. Body mass index (BMI) was calculated from reported height and weight. Associations were examined using Cox proportional hazards modeling with some analyses stratified by smoking (current or never) and educational status (less than complete high school or high school graduate). RESULTS: There was a significant interaction between ethnicity and BMI for both all-cause (p<0.05) and CVD mortality (p<0.001). BMI (as a continuous variable) was associated with all-cause mortality in white women in all four groups defined by smoking and education. In black women with less than a high school education, there were no significant associations between BMI mortality. For high school-educated black women, there was a significant association between BMI and all-cause mortality. Among never smoking women with at least a high school education, models using the lowest BMI as the reference indicated a 40% higher risk of all-cause mortality at a BMI of 35.9 in black women vs. 27.3 in white women. DISCUSSION: The impact of BMI on mortality was modified by educational level in black women; however, BMI was a less potent risk factor in black women than in white women in the same category of educational status.

The National Women's Study: relationship of victimization and posttraumatic stress disorder to bulimia nervosa.

OBJECTIVE: In recent years there has been increased interest regarding the role of crime victimization in the development and/or maintenance of eating disorders, particularly bulimia nervosa. METHOD: To examine the relationship among assault, bulimia nervosa, and binge eating disorder, a national, representative sample of 3,006 women completed structured telephone interviews. RESULTS: Lifetime prevalence of completed, forcible rape for respondents with bulimia nervosa was 26.6%, as compared with 11.5% for respondents with binge eating disorder and 13.3% for respondents without bulimia nervosa or binge eating disorder. Compared to respondents without bulimia nervosa or binge eating disorder, aggravated assault history was significantly more prevalent in women with bulimia nervosa (26.8%), as was a lifetime history of posttraumatic stress disorder (36.9%). Characteristics of sexual assault experiences were not associated with dysfunctional eating patterns. Specific types of disordered eating such as compensatory behaviors in bulimia nervosa were associated with higher rates of victimization. CONCLUSIONS: In sum, the significantly higher rates of both sexual and aggravated assault among women with bulimia nervosa compared with women without such a diagnosis support the hypothesis that victimization may contribute to the development and/or maintenance of bulimia nervosa.

Effects of body fat distribution on body size estimation accuracy among obese women.

UNLABELLED: Body fat distribution is a reliable predictor of the health risks of obesity. Abdominal obesity (AO) has been associated with various health complications whereas gluteal-femoral obesity (GFO) appears to be less hazardous. Body size overestimation, a type of body image disturbance, is found in a subset of obese persons. OBJECTIVE: The current study examined body size estimation accuracy as a function of body fat distribution. DESIGN: Cross-sectional, retrospective review of clinical records. SUBJECTS: 101 obese women (Mean age = 39.4) joining a weight loss program. MEASUREMENTS: Subjects provided body size estimates using a live video distortion procedure and were grouped into tertiles (AO; Mixed type obesity (MTO); GFO) on the basis of their waist-to-hip ratios. RESULTS: GFO women had significantly lower body size estimates and felt thinner than did AO or MTO women. In addition, more AO women (20.6% vs GFO: 8.8%) overestimated their body size by more than 15% whereas more GFO women (29.4% vs AO: 5.9%) underestimated their body size by more than 15%. CONCLUSION: Body fat distribution appears to be a mediator in body size estimation accuracy. These findings are discussed in terms of possible differences in perceptual and societal experiences among the groups.

Prevalence of binge eating disorder in obese adults seeking weight loss treatment.

Binge eating has been identified as a common problem in samples of obese persons. Earlier studies found that approximately 30% of participants presenting for weight loss treatment could be diagnosed with Binge Eating Disorder (BED). This study investigated the prevalence of BED using the Questionnaire on Eating and Weight Patterns (QEWP) and the Interview for the Diagnosis of Eating Disorders (IDED) in a sample of 468 obese adults seeking weight loss treatment at two research facilities. The study found that only a small percentage of the participants met Diagnostic and Statistical Manual for Mental Disorders, 4th Revision (DSM-IV) diagnostic criteria for BED using either the IDED (1.3%) or QEWP (7.3%). A larger percentage of the sample (10.7% based on the IDED and 20.5% based on the QEWP) reported binge eating, but did not endorse all criteria necessary to warrant a diagnosis of BED. The primary finding of the study was that the prevalence of BED in treatment seeking obese adults was much lower than was reported in previous studies. Also, there was significant discrepancy in prevalence rates of BED as defined by self-report and interview assessment methods, with the interview method yielding lower estimates of prevalence. These findings suggest that the prevalence of BED may be lower than estimates of earlier reports. We recommend that future studies of BED use reliable and valid interview methods and that this research focus on more diverse populations, including men and a variety of racial and ethnic groups.

Neurocognitive deficits in morbidly obese children with obstructive sleep apnea.

Neurocognitive abilities were measured in 14 morbidly obese children, five of whom had obstructive sleep apnea as determined by polysomnography. As in adults, children with obstructive sleep apnea had deficits in learning, memory, and vocabulary. Moreover, apneic/hypopneic events were inversely related to memory and learning performance among the entire sample.

Comorbidity of axis I psychiatric disorders in bulimia nervosa.

BACKGROUND: The coexistence of other psychiatric disorders in patients with bulimia nervosa is of major clinical and theoretical interest. We therefore studied a group of consecutively evaluated bulimic patients. METHOD: The Structured Clinical Interview for DSM-III-R (SCID) was administered to a sample of 59 female patients with DSM-III-R-defined bulimia nervosa. RESULTS: The following frequencies of lifetime Axis I comorbid diagnoses were found (in decreasing frequency): any affective disorder (75%), major depressive disorder (63%), any anxiety disorder (36%), any substance abuse disorder (20%), social phobia (17%), generalized anxiety disorder (12%), and panic disorder (10%). In the 44 cases with an affective disorder, 27 (61%) had the onset of affective disorder, 27 (61%) had the onset of their affective disorder prior to the onset of their bulimia, 15 (34%) afterward, and 2 (5%) concurrently. In the 21 cases with any anxiety disorder, 15 (71%) had the onset of their anxiety disorder prior to the onset of their bulimia, 4 (19%) afterward, and 2 (10%) concurrently. CONCLUSION: These data confirm previous reports of a strong association between bulimia nervosa and affective illness, which in most cases precedes the eating disorder. In addition, a high frequency of anxiety disorders, particularly social phobia, is seen in bulimic patients.

Preliminary report: placebo-controlled, double-blind study of the clinical and metabolic effects of desipramine in panic disorder.

Fifty-six males and females with panic disorder with or without agoraphobia participated in a 12-week, placebo-controlled treatment study of the efficacy of desipramine (DMI). Twenty-six of 28 patients receiving DMI completed the study; 17 of 28 placebo (PBO) recipients completed 12 weeks. Patients receiving DMI responded significantly better than did PBO recipients as measured by Hamilton Anxiety Scale (HAM-A) and global phobia ratings, with a trend toward greater global improvement, but no between-group differences on panic attack frequency were discerned. By Week 12, 22 of 26 (85%) DMI patients were panic-free; 13 of 17 (76%) PBO patients were panic-free. Resting metabolic rate (RMR) was tested on a subset of the patients. Patients receiving DMI showed no effects on RMR or thyroid indices but lost a significant amount of weight; the PBO recipients exhibited no weight loss or RMR effects. In this study, the high PBO response rate obscured treatment group differences on some measures. This study underscores the need for placebo comparisons in treatment studies. In summary, DMI appears to be an effective treatment for panic disorder. DMI appears to have little effect on RMR; a slight but significant weight loss was observed in the DMI but not PBO group.