Effects of Dietary Self-Monitoring, Physical Activity, Liraglutide 3.0 mg, and Placebo on Weight Loss in the SCALE IBT Trial.

INTRODUCTION: Individuals who enroll in intensive behavioral therapy (IBT) programs are asked to make several lifestyle changes simultaneously. However, few studies have examined the relative effects of adherence to different treatment components on weight loss. OBJECTIVE: This secondary analysis of the SCALE IBT trial assessed adherence to the medication regimen, dietary self-monitoring, and physical activity recommendations and their relative contributions to weight change in individuals with obesity who were provided with IBT combined with either liraglutide 3.0 mg or placebo. METHODS: SCALE IBT was a double-blinded, multicenter, randomized controlled trial comparing 56-week weight losses in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140), as an adjunct to IBT. Adherence to dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo) were measured during the 56-week treatment period. A regression model was used to estimate the relative contribution of adherence to each treatment component to weight loss at week 56. RESULTS: The proportion of individuals who adhered to each intervention component decreased over time. Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of -7.2% (95% CI -10.4 to -4.0; p < 0.0001) and -2.0% (95% CI -3.2 to -0.8; p = 0.0009), respectively. Complete adherence to liraglutide predicted an additional weight loss of -6.5% (95% CI -10.2 to -2.9; p = 0.0005) relative to individuals who did not adhere to the medication regimen, while adherence to placebo did not have a statistically significant effect on weight loss (p = 0.33). CONCLUSIONS: High adherence to dietary self-monitoring and use of liraglutide 3.0 mg was associated with clinically relevant weight loss with IBT and adjunctive pharmacotherapy. The effect of adherence to physical activity was significant but smaller.

Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study.

OBJECTIVE: This prospective, observational fMRI study examined changes over time in blood oxygen level dependent (BOLD) response to high- and low-calorie foods (HCF and LCF) in bariatric surgery candidates and weight-stable controls. METHODS: Twenty-two Roux-en-Y gastric bypass (RYGB) participants, 18 vertical sleeve gastrectomy (VSG) participants, and 19 weight-stable controls with severe obesity underwent fMRI before and 6 months after surgery/baseline. BOLD signal change in response to images of HCF vs. LCF was examined in a priori regions of interest. RESULTS: RYGB and VSG participants lost 23.6% and 21.1% of initial weight, respectively, at 6 months, and controls gained 1.0%. Liking ratings for HCF decreased significantly in the RYGB and VSG groups but remained stable in the control group. BOLD response in the ventral tegmental area (VTA) to HCF (vs. LCF) declined significantly more at 6 months in RYGB compared to control participants but not in VSG participants. Changes in fasting ghrelin correlated positively with changes in VTA BOLD signal in both RYGB and VSG but not in control participants. CONCLUSIONS: Results implicate the VTA as a critical site for modulating postsurgical changes in liking of highly palatable foods and suggest ghrelin as a potential substrate requiring further investigation.

Readiness redefined: a behavioral task during screening predicted 1-year weight loss in the look AHEAD study.

OBJECTIVE: Predicting outcome in weight loss trials from baseline characteristics has proved difficult. Readiness to change is typically measured by self-report. METHODS: Performance of a behavioral task, completion of food records, from the screening period in the Look AHEAD study (n = 549 at four clinical centers) was assessed. Completeness of records was measured by the number of words and Arabic numerals (numbers) recorded per day, the number of eating episodes per day, and days per week where physical activity was noted. The primary outcome was weight loss at one year. RESULTS: In univariable analysis, both the number of words recorded and the number of numbers recorded were associated with greater weight loss. In multivariable analysis, individuals who recorded 20-26, 27-33, and ≥34 words per day lost 9.12%, 11.40%, and 12.08% of initial weight, compared to 8.98% for individuals who recorded less than 20 words per day (P values of 0.87, 0.008, and <0.001, respectively, compared to <20 words per day). CONCLUSIONS: Participants who kept more detailed food records at screening lost more weight after 1 year than individuals who kept sparser records. The use of objective behavioral screening tools may improve the assessment of weight loss readiness.

Changes in depression and quality of life in obese individuals with binge eating disorder: bariatric surgery versus lifestyle modification.

BACKGROUND: Obese individuals with binge eating disorder frequently experience impairments in mood and quality of life, which improve with surgical or behavioral weight loss interventions. It is unclear whether these improvements are due to weight loss itself or to additional aspects of treatment, such as group support, or acquisition of cognitive-behavioral skills provided in behavioral interventions. The objective of the study was to compare changes in weight, symptoms of depression, and quality of life in extremely obese individuals with binge eating disorder undergoing bariatric surgery or a lifestyle modification intervention. The study setting was University Hospital. METHODS: Symptoms of depression and quality of life were assessed at baseline and 2, 6, and 12 months in participants undergoing bariatric surgery but no lifestyle intervention (n = 36) and in nonsurgery participants receiving a comprehensive program of lifestyle modification (n = 49). RESULTS: Surgery participants lost significantly more weight than lifestyle participants at 2, 6, and 12 months (P<.001). Significant improvements in mood (as measured by the Beck Depression Inventory-II [BDI-II]) and quality of life (as measured by the Short Form-36) were observed in both groups across the year, but there were no differences between the groups at month 12 (even when controlling for reductions in binge eating). A positive correlation was observed between the magnitude of weight loss and change in BDI-II score when collapsing across groups. Moreover, weight loss at one time point predicted BDI-II score at the next time point, but BDI-II score did not predict subsequent weight loss. CONCLUSIONS: We conclude that similar improvements in mood and quality of life can be expected from either bariatric surgery or lifestyle modification treatments for periods up to 1 year.

Four-year change in cardiorespiratory fitness and influence on glycemic control in adults with type 2 diabetes in a randomized trial: the Look AHEAD Trial.

OBJECTIVE: To examine an intensive lifestyle intervention (ILI) compared with diabetes support and education (DSE) on 4-year change in fitness and physical activity (PA), and to examine the effect of change in fitness and PA, adjusting for potential confounders, on glycemic control in the Look AHEAD Trial. RESEARCH DESIGN AND METHODS: Subjects were overweight/obese adults with type 2 diabetes mellitus (T2DM) with available fitness data at 4 years (n = 3,942).This clinical trial randomized subjects to DSE or ILI. DSE subjects received standard care plus information related to diet, PA, and social support three times per year. ILI subjects received weekly intervention contact for 6 months, which was reduced over the 4-year period, and were prescribed diet and PA. Measures included weight, fitness, PA, and HbA1c. RESULTS: The difference in percent fitness change between ILI and DSE at 4 years was significant after adjustment for baseline fitness and change in weight (3.70 vs. 0.94%; P < 0.01). At 4 years, PA increased by 348 (1,562) kcal/week in ILI vs. 105 (1,309) kcal/week in DSE (P < 0.01). Fitness change at 4 years was inversely related to change in HbA1c after adjustment for clinical site, treatment, baseline HbA1c, prescribed diabetes medication, baseline fitness, and weight change (P < 0.01). Change in PA was not related to change in HbA1c. CONCLUSIONS: A 4-year ILI increased fitness and PA in overweight/obese individuals with T2DM. Change in fitness was associated with improvements in glycemic control, which provides support for interventions to improve fitness in adults with T2DM.

Socially desirable responding by bariatric surgery candidates during psychological assessment.

BACKGROUND: Most bariatric surgery programs in the United States require preoperative psychological evaluations for candidates for surgery. Among those who perform these evaluations is concern that many patients engage in "impression management" or minimizing the symptoms of distress to receive a recommendation to proceed with surgery from the mental health professional. We sought to assess the prevalence of socially desirable responding and its associations with measures of psychological functioning among bariatric surgery candidates at 2 academic medical centers in the United States. METHODS: The participants were male (n = 66) and female (n = 293) bariatric surgery candidates who presented for psychological evaluation. The participants completed 2 measures of socially desirable response styles (Marlowe-Crowne Social Desirability Scale and Personality Assessment Inventory Positive Impression Management scale) and standardized measures of anxiety, depression, and alcohol-related problems. RESULTS: The participants exhibited elevated scores on the social desirability indicators, with 33.3-39.8% scoring above the recommended cut-score on the Personality Assessment Inventory Positive Impression Management scale and 62.3-67% scoring 1 standard deviation above the standardization mean on the Marlowe-Crowne Social Desirability Scale. Scores on the Marlowe-Crowne Social Desirability Scale and Personality Assessment Inventory Positive Impression Management scale correlated inversely with the clinical measures of anxiety and depression, and the high/low scorers on the social desirability indices exhibited significant differences in anxiety and depression. Thus, elevated scores on the social desirability indices were associated with underreporting of certain clinical symptoms. CONCLUSION: A substantial proportion of bariatric surgery candidates appear to present themselves in an overly favorable light during the psychological evaluation. This response style is associated with less reporting of psychological problems and might interfere with the accurate assessment of patient functioning.

Axis I psychopathology in bariatric surgery candidates with and without binge eating disorder: results of structured clinical interviews.

BACKGROUND: Prior studies have reached contradictory conclusions concerning whether binge eating disorder (BED) is associated with greater psychopathology in extremely obese patients who seek bariatric surgery. This study used the Structured Clinical Interview for DSM-IV Diagnoses (SCID) to compare rates of axis I psychopathology in surgery candidates who were determined to have BED or to be currently free of eating disorders. The relationship of BED to other psychosocial functioning and weight loss goals also was examined. METHODS: One hundred ninety five bariatric surgery patients completed the Weight and Lifestyle Inventory and the Beck Depression Inventory-II (BDI-II) and were later administered the Eating Disorder Examination. Of these 195, 44 who were diagnosed with BED, and 61 who were currently free of eating pathology, completed a telephone-administered SCID. RESULTS: Significantly more BED than non-BED participants had a current mood disorder (27.3% vs. 4.9%, p = 0.002) as well as a lifetime history of this condition (52.3% vs. 23.0%, p = 0.003). More BED than non-BED participants also had a current anxiety disorder (27.3% vs. 8.2%, p = 0.014) and lifetime anxiety disorder (36.4% vs. 16.4%, p = 0.019). BED also was associated with greater symptoms of depression, as measured by the BDI-II, as well as with lower self-esteem. BED and non-BED groups, however, did not differ in their desired weight loss goals following surgery. CONCLUSIONS: The present findings indicate that the presence of BED, in patients who seek bariatric surgery, is associated with an increased prevalence of axis I psychopathology, beyond the already elevated rate observed with severe (i.e., class III) obesity.

Weight reduction in diabetes.

Obesity and diabetes incidence and prevalence are rampant in our Westernized civilization; they are both increasing and carry with them many medical complications. There is clear evidence that aggressive treatment of these conditions, in particular preventing weight gain and ideally facilitating weight reduction in patients can minimize and reduce these complications. We review data supporting these observations, and review options and recommendations to support the practitioners in helping their patients achieve these goals safely.

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the Look AHEAD study.

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n = 5,145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5,129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6 ± 6.9% of initial weight at 1 year, compared to 0.7 ± 4.8% for DSE (P < 0.001, effect size = 1.33), and had a reduction of 1.4 ± 4.7 points on the BDI, compared to 0.4 ± 4.5 for DSE (P < 0.001, effect size = 0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly lower in the ILI than DSE group (6.3% vs. 9.6%) (relative risk (RR) = 0.66, 95% confidence interval (CI) = 0.5, 0.8; P < 0.001). In the ILI group, participants with and without symptoms of depression lost 7.8 ± 6.7% and 8.7 ± 6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.

Obesity, psychiatric status, and psychiatric medications.

This article has shown that obesity is related to several psychiatric disorders, the most thoroughly researched of which is depression. In both community and clinical populations, the observed relationship is more consistent in women than in men, and is stronger in more severely obese individuals. The presence of BED also is associated with elevated risk of additional psychopathology. Longitudinal research provides evidence to support a pathway from obesity to depression, as well as one from depression to obesity. Weight loss, particularly with nonpharmacologic methods, appears to have favorable group-level effects on mood, but may be associated with adverse outcomes for some individuals. Persons who require antipsychotic medications are at risk for weight gain and metabolic abnormalities, and their management should be informed by consensus guidelines.

Continuous glucose monitoring to assess the ecologic validity of dietary glycemic index and glycemic load.

BACKGROUND: The circumstances under which the glycemic index (GI) and glycemic load (GL) are derived do not reflect real-world eating behavior. Thus, the ecologic validity of these constructs is incompletely known. OBJECTIVE: This study examined the relation of dietary intake to glycemic response when foods are consumed under free-living conditions. DESIGN: Participants were 26 overweight or obese adults with type 2 diabetes who participated in a randomized trial of lifestyle modification. The current study includes baseline data, before initiation of the intervention. Participants wore a continuous glucose monitor and simultaneously kept a food diary for 3 d. The dietary variables included GI, GL, and intakes of energy, fat, protein, carbohydrate, sugars, and fiber. The glycemic response variables included AUC, mean and SD of continuous glucose monitoring (CGM) values, percentage of CGM values in euglycemic and hyperglycemic ranges, and mean amplitude of glycemic excursions. Relations between daily dietary intake and glycemic outcomes were examined. RESULTS: Data were available from 41 d of monitoring. Partial correlations, controlled for energy intake, indicated that GI or GL was significantly associated with each glycemic response outcome. In multivariate analyses, dietary GI accounted for 10% to 18% of the variance in each glycemic variable, independent of energy and carbohydrate intakes (P < 0.01). CONCLUSIONS: The data support the ecologic validity of the GI and GL constructs in free-living obese adults with type 2 diabetes. GI was the strongest and most consistent independent predictor of glycemic stability and variability.

Binge eating disorder and the outcome of bariatric surgery at one year: a prospective, observational study.

Previous studies have suggested that binge eating disorder (BED) impairs weight loss following bariatric surgery, leading some investigators to recommend that patients receive behavioral treatment for this condition before surgery. However, many of these investigations had significant methodological limitations. The present observational study used a modified intention-to-treat (ITT) population to compare 1-year changes in weight in 59 surgically treated participants, determined preoperatively to be free of a current eating disorder, with changes in 36 individuals judged to have BED. Changes in weight and binge eating in the latter group were compared with those in 49 obese individuals with BED who sought lifestyle modification for weight loss. BED was assessed using criteria proposed for the Diagnostic and Statistical Manual (DSM) 5. At 1 year, surgically treated participants without BED lost 24.2% of initial weight, compared with 22.1% for those with BED (P > 0.309). Both groups achieved clinically significant improvements in several cardiovascular disease (CVD) risk factors. Participants with BED who received lifestyle modification lost 10.3% at 1 year, significantly (P < 0.001) less than surgically treated BED participants. The mean number of binge eating days (in the prior 28 days) fell sharply in both BED groups at 1 year. These two groups did not differ significantly in BED remission rates or in improvements in CVD risk factors. The present results, obtained in carefully studied participants, indicate that the preoperative presence of BED does not attenuate weight loss or improvements in CVD risk factors at 1 year in surgically treated patients. Longer follow-up of participants is required.

Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.

BACKGROUND: Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. PURPOSE: As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons METHODS: The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial's interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared. RESULTS: Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. LIMITATIONS: Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. CONCLUSIONS: Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.

Predictors of attrition and weight loss success: Results from a randomized controlled trial.

Attrition is a common problem in weight loss trials. The present analysis examined several baseline and early-treatment process variables, as predictors of attrition and outcome in a clinical trial that combined pharmacotherapy and behavior therapy for weight loss. Participants were 224 obese adults who were treated with sibutramine alone, lifestyle modification alone, combined therapy, or sibutramine plus brief lifestyle modification. Predictors included baseline characteristics (e.g., demographic, weight-related, psychological, and consumption-related variables), plus attendance, adherence, and weight loss in the early weeks of treatment. Outcomes were attrition and weight loss success (i.e., >or=5% reduction in body weight) at 1 year. Multivariable models, adjusting for other relevant variables, found that younger age and greater baseline depressive symptoms were related to increased odds of attrition (ps

Obesity among those with mental disorders: a National Institute of Mental Health meeting report.

The National Institute of Mental Health convened a meeting in October 2005 to review the literature on obesity, nutrition, and physical activity among those with mental disorders. The findings of this meeting and subsequent update of the literature review are summarized here. Levels of obesity are higher in those with schizophrenia and depression, as is mortality from obesity-related conditions such as coronary heart disease. Medication side effects, particularly the metabolic side effects of antipsychotic medications, contribute to the high levels of obesity in those with schizophrenia, but increased obesity and visceral adiposity have been found in some but not all samples of drug-naïve patients as well. Many of the weight-management strategies used in the general population may be applicable to those with mental disorders, but little is known about the effects of these strategies on this patient population or how these strategies may need to be adapted for the unique needs of those with mental disorders. The minimal research on weight-management programs for those with mental disorders indicates that meaningful changes in dietary intake and physical activity are possible. Physical activity is an important component of any weight-management program, particularly for those with depression, for which a substantial body of research indicates both mental and physical health benefits. Obesity among those with mental disorders has not received adequate research attention, and empirically-based interventions to address the increasing prevalence of obesity and risk of cardiovascular and metabolic diseases in this population are lacking.

Changes in symptoms of depression with weight loss: results of a randomized trial.

Recent studies of rimonabant have re-awakened interest in the possible adverse psychiatric effects of weight loss, as well as of weight loss medications. This study examined changes in symptoms of depression in 194 obese participants (age = 43.7 +/- 10.2 years; BMI = 37.6 +/- 4.1 kg/m(2)) in a 1-year randomized trial of lifestyle modification and medication. Participants were assigned to (i) sibutramine alone; (ii) lifestyle modification alone; (iii) sibutramine plus lifestyle modification (i.e., combined therapy); or (iv) sibutramine plus brief therapy. Participants completed the Beck Depression Inventory-II (BDI-II) at baseline and weeks 6, 10, 18, 26, 40, and 52. At 1 year, participants in combined therapy lost the most weight and those in sibutramine alone the least (12.1 +/- 8.8% vs. 5.5 +/- 6.5%; P < 0.01). Mean BDI-II scores across all participants declined from 8.1 +/- 6.9 to 6.2 +/- 7.7 at 1 year (P < 0.001), with no significant differences among groups. Despite this favorable change, 13.9% of participants (across the four groups) reported potentially discernible increases (>or= 5 points on the BDI-II) in symptoms of depression at week 52. They lost significantly less weight than participants in the rest of the sample (5.4 +/- 7.8% vs. 9.0 +/- 7.8%, respectively; P < 0.03). The baseline prevalence of suicidal ideation was 3.6%. Seven new cases of suicidal ideation were observed during the year, with three in lifestyle modification alone. Further research is needed to identify characteristics of obese patients at risk of negative mood changes (and suicidal ideation) in response to behavioral and pharmacologic therapies.

Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetes.

BACKGROUND: Inconsistent findings have been reported regarding improved health-related quality of life (HRQOL) after weight loss. We tested the efficacy of a weight management program for improving HRQOL in overweight or obese adults diagnosed as having type 2 diabetes mellitus. METHODS: We conducted a randomized multisite clinical trial at 16 outpatient research centers with 2 treatment arms and blinded measurements at baseline and the end of year 1. A total of 5145 participants (mean [SD] age, 58.7 [6.9] years; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 36.0 [5.9]; 59.5% women; 63.1% white) were randomized to an intensive lifestyle intervention (ILI) or to diabetes support and education (DSE). Main outcome measures included the 36-Item Short-Form Health Survey physical component summary (PCS) and mental health component summary (MCS) scores and Beck Depression Inventory II (BDI-II) scores. Baseline mean (SD) scores were 47.9 (7.9) for PCS, 54.0 (8.1) for MCS, and 5.7 (5.0) for BDI-II. RESULTS: Improved HRQOL was demonstrated by the PCS and BDI-II scores (P < .001) in the ILI arm compared with the DSE arm. The largest effect was observed for the PCS score (difference, -2.91; 99% confidence interval, -3.44 to -2.37). The greatest HRQOL improvement occurred in participants with the lowest baseline HRQOL levels. Mean (SD) changes in weight (ILI, -8.77 [8.2] kg and DSE, -0.86 [5.0] kg), improved fitness, and improved physical symptoms mediated treatment effects associated with the BDI-II and PCS. CONCLUSIONS: Overweight adults diagnosed as having type 2 diabetes experienced significant improvement in HRQOL by enrolling in a weight management program that yielded significant weight loss, improved physical fitness, and reduced physical symptoms. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00017953.

Self-reported stigmatization among candidates for bariatric surgery.

The popularity of bariatric surgery has increased the focus on the psychological aspects of extreme obesity. Although a growing literature has documented the psychosocial burden associated with extreme obesity, surprisingly little attention has been paid to the experience of weight-related stigmatization among extremely obese individuals. The present study investigated self-reported experiences of weight-related stigmatization, weight-related quality of life, and depressive symptoms among 117 extremely obese individuals (BMI = 48.2 +/- 7.5 kg/m2) who presented for bariatric surgery at the Hospital of the University of Pennsylvania. In general, these individuals reported infrequent weight-related stigma, which was unrelated to BMI. Some specific forms of stigmatization, however, appear to be related to body size. The occurrence of stigmatization was associated with poorer weight-related quality of life and greater symptoms of depression.