Weight bias internalization in a commercial weight management sample: prevalence and correlates.

OBJECTIVE: Weight bias internalization (WBI) is associated with poor weight-related health. The purpose of this study was to identify the prevalence and correlates of WBI in a large sample of adults in a commercial weight management programme. METHODS: WW (the new Weight Watchers) members participated in an online survey. Participants (N = 18,769) completed the 10-item Weight Bias Internalization Scale - Modified (WBIS-M) and the Weight Self-Stigma Questionnaire (WSSQ). Participants reported details about weight-stigmatizing experiences, including the onset, frequency and distress, and interpersonal sources of weight stigma. Participants self-reported their demographics, weight history, and height and weight (to compute body mass index [BMI]). RESULTS: Weight bias internalization was relatively high compared with the general population (mean WBIS-M score = 4.3 ± 1.4; mean WSSQ total score = 35.2 ± 9.7). WBI was higher among participants who were female, younger and had higher BMIs (p < 0.001) and lower among those who were Black and were widowed or had a romantic partner (p < 0.001). Onset of weight stigma in childhood and young adulthood, and recent distress due to weight stigma, predicted higher WBI. Extended family and school sources of weight stigma had weaker associations with WBI than did other interpersonal sources. CONCLUSIONS: Weight bias was internalized by a significant proportion of adults enrolled in a commercial weight management programme. A phenotype of WBI includes demographic characteristics and the timing and sources of weight stigma.

A randomized controlled trial of lorcaserin and lifestyle counselling for weight loss maintenance: changes in emotion- and stress-related eating, food cravings and appetite.

Anti-obesity medication may help people maintain diet-induced reductions in appetite. The present exploratory analysis assessed the effects of lorcaserin on changes at 24 weeks post-randomization in emotion- and stress-related eating, food cravings and other measures of appetite (i.e. binge eating, cognitive restraint, disinhibition, hunger, preoccupation with eating and fullness). The parent study investigated the efficacy of combined lorcaserin and behavioural treatment in facilitating weight loss maintenance (WLM) in 137 adults (mean age = 46.1 years, 86.1% female, 68.6% black) who had lost ≥5% of initial weight during a 14-week, low-calorie diet (LCD) run-in. Participants were randomly assigned to lorcaserin or placebo and were provided with group WLM counselling sessions. Emotion- and stress-related eating, food cravings and appetite were measured at the start of the LCD (week -14), randomization (0) and week 24. From randomization, lorcaserin-treated participants had significantly greater improvements in emotion- and stress-related eating compared to placebo-treated participants (P = 0.04). However, groups did not differ significantly after randomization in changes in the frequency of food cravings, binge eating or other measures of appetite (Ps > 0.05). Compared to placebo, lorcaserin may improve emotion- and stress-related eating.

Everyday discrimination in a racially diverse sample of patients with obesity.

Weight discrimination affects a significant proportion of individuals with obesity and contributes to poor mental and physical health. Prior research on weight discrimination has been limited by a lack of racial diversity in samples and has not considered other potential forms of discrimination that individuals with obesity may experience. The current study assessed different reasons for discrimination in a racially diverse sample of treatment-seeking individuals with obesity (N = 122, 66.4% black, mean body mass index = 38.5 ± 6.2 kg/m2 ). Results showed that over half of participants reported experiencing at least one form of repeated discrimination, and 30% reported two or more reasons for discrimination. Race and weight were the most commonly reported reasons for repeated, everyday instances of discrimination. Among participants who reported experiencing weight discrimination (28.7%), over 80% reported experiencing at least one other form of discrimination, with 60% reporting discrimination due to race. These findings indicate that individuals with obesity may face multiple forms of discrimination in their daily lives. Further research is needed to understand how all forms of discrimination contribute to obesity-related health problems.

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

OBJECTIVE: The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. METHODS: The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. RESULTS: During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. CONCLUSIONS: The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

Changes in eating, physical activity and related behaviors in a primary care-based weight loss intervention.

OBJECTIVE: To examine changes in eating behaviors and physical activity, as well as predictors of weight loss success, in obese adults who participated in a 2-year behavioral weight loss intervention conducted in a primary care setting. DESIGN: A longitudinal, randomized controlled, multisite trial. SUBJECTS: Three hundred ninety obese (body mass index, 30-50 kg m(-2)) adults, ≥ 21 years, in the Philadelphia region. METHODS: Participants were assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education on diet and exercise); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly lifestyle counseling (LC) sessions about behavioral weight control); or (3) Enhanced Brief LC (the previous intervention with a choice of meal replacements or weight loss medication). RESULTS: At month 24, participants in both Brief LC and Enhanced Brief LC reported significantly greater improvements in mean (± s.e.) dietary restraint than those in Usual Care (4.4 ± 0.5, 4.8 ± 0.5 and 2.8 ± 0.5, respectively; both P-values ≤ 0.016). The percentage of calories from fat, along with fruit and vegetable consumption, did not differ significantly among the three groups. At month 24, both the Brief LC and Enhanced Brief LC groups reported significantly greater increases than usual care in energy expenditure (kcal per week) from moderately vigorous activity (+593.4 ± 175.9, +415.4 ± 179.6 and -70.4 ± 185.5 kcal per week, respectively; both P-values ≤ 0.037). The strongest predictor of weight loss at month 6 (partial R(2)=33.4%, P<0.0001) and at month 24 (partial R(2)=19.3%, P<0.001) was food records completed during the first 6 months. Participants who achieved a 5% weight loss at month 6 had 4.7 times greater odds of maintaining a ≥ 5% weight loss at month 24. CONCLUSIONS: A behavioral weight loss intervention delivered in a primary care setting can result in significant weight loss, with corresponding improvements in eating restraint and energy expenditure. Moreover, completion of food records, along with weight loss at month 6, is a strong predictor of long-term weight loss.

Effect of lifestyle intervention on cardiometabolic risk factors: results of the POWER-UP trial.

OBJECTIVE: To investigate the effects of three weight loss interventions on cardiometabolic risk factors, including blood pressure, lipids, glucose and markers of insulin resistance and inflammation. We also examined whether categories of incremental weight change conferred greater improvements on these parameters. METHODS: This 2-year trial was conducted in a primary care setting and included 390 obese participants who were randomly assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education about weight management); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly behavioral counseling provided by a trained auxiliary health-care provider); or (3) Enhanced Brief Lifestyle Counseling (the same care as described for the previous intervention, plus weight loss medications or meal replacements). The primary outcome was change in cardiometabolic risk factors among groups. RESULTS: At month 24, participants in Enhanced Brief Lifestyle Counseling lost significantly more weight than those in Usual Care (4.6 vs 1.7 kg), with no other significant differences between groups. Enhanced Brief Lifestyle Counseling produced significantly greater improvements in high-density lipoprotein (HDL) cholesterol and triglyceride levels at one or more assessments, compared with the other two interventions. Markers of insulin resistance also improved significantly more in this group throughout the 2 years. Collapsing across the three groups, greater weight loss was associated with greater improvements in triglycerides, HDL cholesterol and markers of insulin resistance and inflammation at month 24, but was not significantly associated with reductions in blood pressure, total cholesterol and low-density lipoprotein cholesterol at any time. CONCLUSIONS: Enhanced Brief Lifestyle Counseling, which produced the largest weight loss, was generally associated with the greatest improvements in cardiovascular risk factors. These findings suggest that an intensive weight loss intervention, delivered in a primary care setting, can help obese individuals improve some cardiometabolic risk factors.

The impact of a primary care-based weight loss intervention on the quality of life.

OBJECTIVE: This study investigated changes in the quality of life of men and women who participated in a primary care-based weight loss intervention program. METHODS: Participants were enrolled in a 2-year randomized clinical trial (POWER-UP) conducted at the University of Pennsylvania and in six affiliated primary care practices. Inclusion criteria included the presence of obesity (body mass index of 30-50 kg m(-2)) and at least two components of the metabolic syndrome. MAIN OUTCOME MEASURES: Quality of life was assessed by three measures: the Short Form Health Survey (SF-12); the Impact of Weight on Quality of Life-Lite; and the EuroQol-5D. RESULTS: Six months after the onset of treatment, and with a mean weight loss of 3.9 ± 0.3 kg, participants reported significant improvements on all measures of interest with the exception of the Mental Component Score of the SF-12. These changes remained significantly improved from baseline to month 24, with the exception of the EuroQol-5D. Many of these improvements were correlated with the magnitude of weight loss and, for the most part, were consistent across gender and ethnic group. CONCLUSIONS: Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of the quality of life with a modest weight loss of 3.7% of initial weight, which was achieved within the first 6 months of treatment. The majority of these improvements were maintained at month 24, when participants had lost 3.0% of their weight.

Managing obesity in primary care practice: an overview with perspective from the POWER-UP study.

Primary care practitioners (PCPs) have been encouraged to screen all adults for obesity and to offer behavioral weight loss counseling to the affected individuals. However, there is limited research and guidance on how to provide such intervention in primary care settings. This led the National Heart, Lung and Blood Institute in 2005 to issue a request for applications to investigate the management of obesity in routine clinical care. Three institutions were funded under a cooperative agreement to undertake the practice-based opportunities for weight reduction (POWER) trials. The present article reviews selected randomized controlled trials, published before the initiation of POWER, and then provides a detailed overview of the rationale, methods and results of the POWER trial conducted at the University of Pennsylvania (POWER-UP). POWER-UP's findings are briefly compared with those from the two other POWER trials, conducted at Johns Hopkins University and Harvard University/Washington University. The methods of delivering behavioral weight loss counseling differed markedly across the three trials, as captured by an algorithm presented in the article. Delivery methods ranged from having medical assistants and PCPs from the practices provide counseling to using a commercially available call center, coordinated with an interactive website. Evaluation of the efficacy of primary care-based weight loss interventions must be considered in light of costs, as discussed in relation to the recent treatment model proposed by the Centers for Medicare and Medicaid Services.

Cost-effectiveness of a primary care intervention to treat obesity.

BACKGROUND: Data on the cost-effectiveness of the behavioral treatment of obesity are not conclusive. The cost-effectiveness of treatment in primary care settings is particularly relevant. METHODS: We conducted a within-trial cost-effectiveness analysis of a primary care-based obesity intervention. Study participants were randomized to: Usual Care (UC; quarterly visits with their primary care provider); Brief Lifestyle Counseling (BLC; quarterly provider visits plus monthly weight loss counseling visits) or Enhanced Brief Lifestyle Counseling (EBLC; all above interventions, plus choice of meal replacements or weight loss medication). A health-care payer perspective was used. Intervention costs were estimated from tracking data obtained prospectively. Quality-adjusted life years (QALYs) were estimated with the EuroQol-5D. We estimated cost per kilogram-year of weight loss and cost per QALY. RESULTS: Weight losses after 2 years were 1.7, 2.9 and 4.6 kg for UC, BLC and EBLC, respectively (P=0.003 for comparison of EBLC vs UC). The incremental cost per kilogram-year lost was $292 for EBLC compared with UC (95% confidence interval (CI): $219-$437). The short-term incremental cost per QALY was $115,397, but the 95% CI were undefined. Comparison of short-term cost per kg with published estimates of longer-term cost per QALY suggested that the intervention could be cost-effective over the long term (≥ 10 years). CONCLUSIONS: A primary care intervention that includes monthly counseling visits and a choice of meal replacements or weight loss medication could be a cost-effective treatment for obesity over the long term. However, additional studies are needed on the cost-effectiveness of behavioral treatment of obesity.

Gender differences in the relationship between symptoms of depression and high-sensitivity CRP.

BACKGROUND: Depression has been associated with increased risk of cardiovascular disease. The inflammatory marker C-reactive protein (CRP) has also been identified as an independent predictor of short- and long-term cardiovascular disease events. Inflammation may influence the relationship between depression and cardiovascular disease. OBJECTIVE: The objective of this study was to investigate the association between symptoms of depression and high-sensitivity CRP (hs-CRP) in an obese clinical population. We also sought to determine whether this relationship was different in men and women, given prior reports of a gender effect. METHODS: Symptoms of depression and hs-CRP were measured in 390 participants enrolled in a weight loss intervention trial that was delivered in a primary care setting. Symptoms of depression were evaluated with the Patient Health Questionnaire-8 (PHQ-8), in which a score ≥ 10 is consistent with major depression. RESULTS: A total of 58 (15.2%) participants reported a PHQ-8 score ≥ 10. The median (interquartile range) hs-CRP concentration was significantly higher in participants with symptoms consistent with major depression (7.7 (4.2-13) mg l(-1)) compared with those without depression (5.1 (3-9.7) mg l(-1); P<0.01). Symptoms consistent with major depression were significantly associated with log-transformed hs-CRP concentrations in an analysis adjusted for age, gender, obesity class and other metabolic variables (P=0.04). When interaction by gender was examined, this relationship remained significant in men (P<0.01) but not in women (P=0.32). CONCLUSIONS: Symptoms consistent with major depression were significantly associated with hs-CRP in men only, even after adjusting for age, obesity class, metabolic variables and medications known to affect inflammation. This finding suggests that there are biologic differences between men and women that may modify the relationship between hs-CRP and depression. Further studies are needed to elucidate the biologic basis for these findings.

Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study.

OBJECTIVE: Liraglutide, a once-daily human glucagon-like peptide-1 analog, induced clinically meaningful weight loss in a phase 2 study in obese individuals without diabetes. The present randomized phase 3 trial assessed the efficacy of liraglutide in maintaining weight loss achieved with a low-calorie diet (LCD). METHODS: Obese/overweight participants (≥18 years, body mass index ≥30 kg m(-2) or ≥27 kg m(-2) with comorbidities) who lost ≥5% of initial weight during a LCD run-in were randomly assigned to liraglutide 3.0 mg per day or placebo (subcutaneous administration) for 56 weeks. Diet and exercise counseling were provided throughout the trial. Co-primary end points were percentage weight change from randomization, the proportion of participants that maintained the initial ≥5% weight loss, and the proportion that lost ≥5% of randomization weight (intention-to-treat analysis). ClinicalTrials.gov identifier: NCT00781937. RESULTS: Participants (n=422) lost a mean 6.0% (s.d. 0.9) of screening weight during run-in. From randomization to week 56, weight decreased an additional mean 6.2% (s.d. 7.3) with liraglutide and 0.2% (s.d. 7.0) with placebo (estimated difference -6.1% (95% class intervals -7.5 to -4.6), P<0.0001). More participants receiving liraglutide (81.4%) maintained the ≥5% run-in weight loss, compared with those receiving placebo (48.9%) (estimated odds ratio 4.8 (3.0; 7.7), P<0.0001), and 50.5% versus 21.8% of participants lost ≥5% of randomization weight (estimated odds ratio 3.9 (2.4; 6.1), P<0.0001). Liraglutide produced small but statistically significant improvements in several cardiometabolic risk factors compared with placebo. Gastrointestinal (GI) disorders were reported more frequently with liraglutide than placebo, but most events were transient, and mild or moderate in severity. CONCLUSION: Liraglutide, with diet and exercise, maintained weight loss achieved by caloric restriction and induced further weight loss over 56 weeks. Improvements in some cardiovascular disease-risk factors were also observed. Liraglutide, prescribed as 3.0 mg per day, holds promise for improving the maintenance of lost weight.

A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program.

OBJECTIVE: This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250-1550 kcal per day) and physical activity (200 min per week). RESULTS: While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): -5.8 to -8.8 kg], compared with 2.2 kg (95% CI: -0.7 to -3.7 kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost 5% of initial weight (54.0% vs 14.0%, P<0.0001) and 10% (26.0% vs 6.0%, P<0.0001). HbA1c declined by 0.7% (95% CI: -0.4 to -1.0%) in the PCD group, compared with 0.4% (95% CI: -0.1 to -0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r=0.52, P<0.0001). CONCLUSIONS: These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

Evidence for prospective associations among depression and obesity in population-based studies.

Obesity may lead to depression or be one of its consequences. We reviewed population-based studies in order to, first, identify the most commonly used research methods, and, second, to evaluate the strength of evidence for prospective associations among obesity and depression. We examined 25 studies, of which 10 tested 'obesity-to-depression' pathways, and 15 tested 'depression-to-obesity' pathways. Descriptive statistics summarized the frequency with which various measurements, designs and data analytic strategies were used. We tallied the number of studies that reported any vs. no statistically significant associations, and report on effect sizes, identified moderating variables within reports, and sought common findings across studies. Results indicated considerable methodological heterogeneity in the literature. Depression was assessed by clinical interview in 44% of studies, weight and height were directly measured in 32%, and only 12% used both. In total, 80% of the studies reported significant obesity-to-depression associations, with odds ratios generally in the range of 1.0 to 2.0, while only 53% of the studies reported significant depression-to-obesity associations. Sex was a common moderating variable. Thus, there was good evidence that obesity is prospectively associated with increased depression, with less consistent evidence that depression leads to obesity. Recommendations for future research regarding study samples, measurement and data analysis are provided.

Intentional weight loss and changes in symptoms of depression: a systematic review and meta-analysis.

OBJECTIVE: Obesity is related to increased risk of several health complications, including depression. Many studies have reported improvements in mood with weight loss, but results have been equivocal. The present meta-analysis examined changes in symptoms of depression that were reported in trials of weight loss interventions. Between-groups comparisons of different weight loss methods (for example, lifestyle modification, diet-alone and pharmacotherapy) were examined, as were within-group changes for each treatment type. METHOD: MEDLINE was searched for articles published between 1950 and January 2009. Several obesity-related terms were intersected with terms related to depression. Results were filtered to return only studies of human subjects, published in English. Of 5971 articles, 394 were randomized controlled trials. Articles were excluded if they did not report mean changes in weight or symptoms of depression, included children or persons with psychiatric disorders (other than depression), or provided insufficient data for analysis. Thirty-one studies (n=7937) were included. Two authors independently extracted a description of each study treatment, sample characteristics, assessment methods and changes in weight and symptoms of depression. Treatments were categorized as lifestyle modification, non-dieting, dietary counseling, diet-alone, exercise-alone, pharmacotherapy, placebo or control interventions. RESULTS: Random effects models found that lifestyle modification was superior to control and non-dieting interventions for reducing symptoms of depression, and marginally better than dietary counseling and exercise-alone programs. Exercise-alone programs were superior to controls. No differences were found for comparisons of pharmacologic agents and placebos. Within-group analyses found significant reductions in symptoms of depression for nearly all active interventions. A meta-regression found no relationship between changes in weight and changes in symptoms of depression in lifestyle modification interventions. CONCLUSIONS: On average, obese individuals in weight loss trials experienced reductions in symptoms of depression. Future studies should examine incidence and resolution of clinically significant depressive disorders with weight loss interventions.

Targeting dietary fat or glycemic load in the treatment of obesity and type 2 diabetes: a randomized controlled trial.

AIMS: To compare the effects of lifestyle modification programs that prescribe low-glycemic load (GL) vs. low-fat diets in a randomized trial. METHODS: Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction, delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity. Changes in weight, HbA(1c), and other metabolic parameters were compared at weeks 20 and 40. RESULTS: Weight loss did not differ between groups at week 20 (low-fat: -5.7±3.7%; low-GL: -6.7±4.4%, p=.26) or week 40 (low-fat: -4.5±7.5%; low-GL: -6.4±8.2%, p=.28). Adjusting for changes in antidiabetic medications, subjects on the low-GL diet had larger reductions in HbA(1c) than those on the low-fat diet at week 20 (low-fat: -0.3±0.6%; low-GL: -0.7±0.6%, p=.01), and week 40 (low-fat: -0.1±1.2%; low-GL: -0.8±1.3%; p=.01). Groups did not differ significantly on any other metabolic outcomes (p≥.06). CONCLUSIONS: Results suggest that targeting GL, rather than dietary fat, in a low-calorie diet can significantly enhance the effect of weight loss on HbA(1c) in patients with type 2 diabetes.

Relation of health-related quality of life to metabolic syndrome, obesity, depression and comorbid illnesses.

BACKGROUND: Metabolic syndrome has been associated with impaired health-related quality of life (HRQoL) in several studies. Many studies used only one HRQoL measure and failed to adjust for important confounding variables, including obesity, depression and comorbid conditions. OBJECTIVE: To investigate the relationship between metabolic syndrome and HRQoL using multiple measures. We also sought to determine whether increasing body mass index or diabetes status further modified this relationship. METHODS: This cross-sectional study included 390 obese participants with elevated waist circumference and at least one other criterion for metabolic syndrome. Of these 390 participants, 269 had metabolic syndrome (that is, they met 3 out of the 5 criteria specified by the NCEP (National Cholesterol Education Program)) and 121 did not. Participants were enrolled in a primary care-based weight-reduction trial. HRQoL was assessed using two generic instruments, the Medical Outcomes Study Short-Form 12 and the EuroQol-5D, as well as an obesity-specific measure, the Impact of Weight on Quality of Life. Differences in HRQoL were compared among participants with and without metabolic syndrome. Multivariable linear regression was used to determine how HRQoL varied according to metabolic syndrome status, and whether factors including weight, depression and burden of comorbid disease modified this relationship. RESULTS: Metabolic syndrome was not associated with HRQoL as assessed by any of the measures. In univariable analysis, depression, disease burden and employment status were significantly associated with worse HRQoL on all instruments. In multivariable models, only depression remained significantly associated with reduced HRQoL on all measures. Increasing obesity and diabetes status did not modify the relationship between metabolic syndrome and HRQoL. CONCLUSION: In contrast to previous studies, metabolic syndrome was not associated with impaired HRQoL as assessed by multiple measures. This suggests that metabolic syndrome in itself is not associated with decreased HRQoL, but other factors such as obesity, depression and greater disease burden may significantly influence the quality of life in this population.

Cardiovascular disease risk factors, depression symptoms and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes.

AIMS/HYPOTHESIS: To determine the associations of baseline depression symptoms and use of antidepressant medicines (ADMs) with baseline cardiovascular disease (CVD) risk factors in Look AHEAD (Action for Health in Diabetes) trial participants. METHODS: Look AHEAD participants (n = 5,145; age 58.7 +/- 6.8 years; BMI 35.8 +/- 5.8 kg/m(2)) were assessed for CVD risk factors (elevated HbA(1c) or insulin use, elevated BP or antihypertensive use, elevated lipid levels or lipid-lowering medication, current smoking, BMI > or = 30 kg/m(2), lower peak exercise capacity assessed as metabolic equivalents [METs], and ankle-brachial index <0.9 or >1.3). Participants also completed the Beck Depression Inventory (BDI) and reported their use of ADMs. RESULTS: Of the participants, 14.7% had BDI scores > or = 11, consistent with mild-moderate depression, and 16.5% took ADMs; 4.4% had both depression markers (i.e. elevated symptom scores and took ADMs). In logistic regression analyses of CVD risk (elevated risk factor or use of medication to control the risk factor), controlled for demographic factors, continuous BDI scores and ADM use were each independently associated with elevated BP (or medication), current smoking, BMI > or = 30 kg/m(2) and lower MET values. ADM use was also associated with elevated serum lipids or use of lipid-lowering medication. CONCLUSIONS/INTERPRETATION: Among Look AHEAD participants, depression symptoms or ADM use on entry to the study were each independently associated with a wide range of CVD risk factors. Future research should assess the temporal dynamics of the relationships of depression symptoms and ADM use with CVD risk factors. TRIAL REGISTRATION: Clinicaltrials.gov NCT00017953 FUNDING: This study is funded by the National Institutes of Health with additional support from the Centers for Disease Control and Prevention.

Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis.

Clinical trials of obesity treatments have been limited by substantial dropout. Participant-level variables do not reliably predict attrition, and study-level variables have not yet been examined. We searched MEDLINE and identified 24 large randomized controlled trials of weight loss medications. These trials were comprised of 23 placebo and 32 drug groups. Two authors independently extracted the following for each treatment group: (i) treatment received; (ii) design characteristics (inclusion of a lead-in period, selection of participants with weight-related comorbidities, study location and number of study visits); (iii) sample characteristics (sample size, % female, and mean baseline age and body mass index); and (iv) attrition (total, adverse event [AE]-related and non-AE-related) at 1 year. The primary outcome was total attrition, which was significantly related to treatment (i.e. 34.9%, 28.6%, 28.3% and 35.1% in placebo, orlistat, sibutramine and rimonabant groups, respectively, P < 0.0001). In adjusted multivariable models, total attrition was significantly lower in groups that completed a pre-randomization lead-in period than in those that did not (29.1% vs. 39.9%, P < 0.01). Gender also was significantly related to total attrition; groups with more women had higher dropout (P < 0.01). The pattern was similar for predicting non-AE-related attrition. Findings suggest ways to design studies that maximize retention.