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Context Observational studies suggest that low vitamin D status may be a risk factor for cancer. Objective In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine if vitamin D supplementation lowers the risk of cancer and precancers. Methods The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups. Results Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The HR of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07). Conclusion In the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.

Objective Fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG) from a 75-g oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) can lead to different results when diagnosing prediabetes and diabetes. The Hemoglobin Glycation Index (HGI) quantifies the interindividual variation in glycation resulting in discrepancies between FPG and HbA1c. We used data from the Vitamin D and Type 2 Diabetes (D2d) study to calculate HGI, to identify HGI-associated variables, and to determine how HGI affects prediabetes and diabetes diagnosis. Measurements A linear regression equation [HbA1c (%) = 0.0164 × FPG (mg/dL) + 4.2] was derived using the screening cohort (n = 6829) and applied to calculate predicted HbA1c. This was subtracted from the observed HbA1c to determine HGI in the baseline cohort with 2hPG data (n = 3945). Baseline variables plus prediabetes and diabetes diagnosis by FPG, HbA1c, and 2hPG were compared among low, moderate, and high HGI subgroups. Results The proportion of women and Black/African American individuals increased from low to high HGI subgroups. Mean FPG decreased and mean HbA1c increased from low to high HGI subgroups, consistent with the HGI calculation; however, mean 2hPG was not significantly different among HGI subgroups. Conclusions High HGI was associated with Black race and female sex as reported previously. The observation that 2hPG was not different across HGI subgroups suggests that variation in postprandial glucose is not a significant source of population variation in HGI. Exclusive use of HbA1c for diagnosis will classify more Black individuals and women as having prediabetes compared with using FPG or 2hPG.

Background Obesity is associated with heart failure with preserved ejection fraction (HFpEF). Weight loss can improve exercise capacity in HFpEF. However, previously reported methods of weight loss are impractical for widespread clinical implementation. We tested the hypothesis that an intensive lifestyle modification program would lead to relevant weight loss and improvement in functional status in patients with HFpEF and obesity. Methods and Results Patients with ejection fraction >45%, at least 1 objective criteria for HFpEF, and body mass index ≥30 kg/m 2 were offered enrollment in an established 15‐week weight management program that included weekly visits for counseling, weight checks, and provision of meal replacements. At baseline, 15 weeks, and 26 weeks, Minnesota Living With Heart Failure score, 6‐minute walk distance, echocardiography, and laboratory variables were assessed. A total of 41 patients completed the study (mean body mass index, 40.8 kg/m 2 ), 74% of whom lost >5% of their baseline body weight following the 15‐week program. At 15 weeks, mean 6‐minute walk distance increased from 223 to 281 m ( P =0.001) and then decreased to 267 m at 26 weeks. Minnesota Living With Heart Failure score improved from 59.9 to 37.3 at 15 weeks ( P r =0.452; P =0.000) and 6‐minute walk distance ( r =−0.388; P Conclusions In a diverse population of patients with obesity and HFpEF, clinically relevant weight loss can be achieved with a pragmatic 15‐week program. This is associated with significant improvements in quality of life and exercise capacity. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02911337.

WW is a validated behavioral weight management program that encourages healthy habits. WW developed a method of personalizing the SmartPoints® budget depending on dietary and lifestyle preferences, and participants were placed into one of three plans as a pilot evaluation of this new program. In this 6-month, single-arm pilot study, participants attended weekly workshops and used an app to monitor eating and physical activity. Baseline and 6-month assessments included weight, waist circumference, blood pressure, energy intake, cravings, happiness, health-related quality of life, hunger, and fullness. Of 145 adults assessed at baseline, 126 (87%) provided follow-up data. Pre–post changes showed significant reductions in body weight (7.39% ± 5.93%), calories consumed (24.79% ± 32.35%) and significant improvements in cravings, happiness, all SF-36 scales and hunger but not in fullness. Greater % weight loss was related to greater improvements in happiness (r = .38, p < .001), general health perceptions (r = .29, p = .001), and health change (r = .31, p = .001), and greater reduction in role limitations due to personal or emotional problems (r = .24, p = .01). Greater % reduction in caloric intake was associated with greater reductions in cravings (r = .23, p = .01), as well as with greater improvements in happiness (r = .23, p = .01), physical functioning (r = .23, p = .01), and general health perceptions (r = .23, p = .01). Participants in this modified program achieved significant weight loss, regardless of dietary plan, as well as improvements in a variety of other physical and psychological constructs. Those who achieved greater reductions in weight also reported greater improvements in cravings, happiness and some quality of life measures.

The aim of the study was to assess weight loss outcomes among participants (N = 1090) of a weight management program across multiple worksites (N = 10) in a retrospective analysis.Weekly classes focused on diet, exercise, and behavior change. One employer provided incentives for weight loss and two incentivized weight loss and class attendance.Mean weight loss (N = 1090; 79.3% female) was -2.9% (SD = 3.0%). Average number of classes attended was 6.87/10 (SD = 2.9) and was significantly correlated with percent weight change (r = -0.46; P 0.001). Participants incentivized for attendance attended significantly more classes (M = 7.5, SD = 2.8) than did those not so incentivized (M = 6.4, SD = 2.9, P 0.001), but did not lose more weight (P = 0.24). Participants incentivized for weight loss did not lose significantly more weight than those not so incentivized (P = 0.26).These data support the effectiveness of this worksite program. Utilizing incentives to promote class attendance may be beneficial for increasing engagement in similar programs.

IMPORTANCE: Weight loss improves cardiometabolic risk factors in people with overweight or obesity. Intensive lifestyle intervention and pharmacotherapy are the most effective noninvasive weight loss approaches. OBJECTIVE: To compare the effects of once-weekly subcutaneous semaglutide, 2.4 mg vs placebo for weight management as an adjunct to intensive behavioral therapy with initial low-calorie diet in adults with overweight or obesity. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30). INTERVENTIONS: Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks. MAIN OUTCOMES AND MEASURES: The co–primary end points were percentage change in body weight and the loss of 5% or more of baseline weight by week 68. Confirmatory secondary end points included losses of at least 10% or 15% of baseline weight. RESULTS: Of 611 randomized participants (495 women [81.0%], mean age 46 years [SD, 13], body weight 105.8 kg [SD, 22.9], and body mass index 38.0 [SD, 6.7]), 567 (92.8%) completed the trial, and 505 (82.7%) were receiving treatment at trial end. At week 68, the estimated mean body weight change from baseline was –16.0% for semaglutide vs –5.7% for placebo (difference, −10.3 percentage points [95% CI, −12.0 to −8.6]; P

Background: Obesity is associated with incident heart failure (HF), particularly HF with preserved ejection fraction (HFpEF). Weight loss is difficult to achieve in patients with limited physical capacity and the benefits remain uncertain in established HF. Methods: Patients with EF > 50% and at least 1 objective criteria for HFpEF (BNP 200 pg/ml, elevated resting or exercise wedge pressure (15 or 25 mmHg) or pulmonary edema on CXR) and BMI 30 kg/m2 were enrolled in a 15-week weight management program that entailed weekly counseling, weight checks, and meal replacement (twice daily weeks 1-8, once daily weeks 9-12). Primary endpoints were change from baseline to 15-weeks for weight, Minnesota Living With HF (MLWHF) score and 6 minute walk (6MW). Paired t-test was used to test for differences from baseline to the 15 week clinical endpoint, and one-way ANOVA was used to evaluate if these differences persisted at 26 week follow up. Results: 65 patients signed consent, 41 completed the 15-week program and 37 had 26-week follow up. Mean age was 67±9 years, BMI 41±6 kg/m 2 , 65% were female, and 43% black. Mean weight decreased by 8.1±6.6 kg at the 15-week endpoint (p Conclusions: Clinically relevant weight loss is possible in patients with established HFpEF and when it occurs, this is associated with significant improvements in quality of life and exercise capacity. There may be racial differences in the biochemical response to weight management in this population.

Background Obesity is a major public health issue, and new pharmaceuticals for weight management are needed. Therefore, we evaluated the efficacy and safety of the glucagon-like peptide-1 (GLP-1) analogue semaglutide in comparison with liraglutide and a placebo in promoting weight loss. Methods We did a randomised, double-blind, placebo and active controlled, multicentre, dose-ranging, phase 2 trial. The study was done in eight countries involving 71 clinical sites. Eligible participants were adults (≥18 years) without diabetes and with a body-mass index (BMI) of 30 kg/m 2 or more. We randomly assigned participants (6:1) to each active treatment group (ie, semaglutide [0·05 mg, 0·1 mg, 0·2 mg, 0·3 mg, or 0·4 mg; initiated at 0·05 mg per day and incrementally escalated every 4 weeks] or liraglutide [3·0 mg; initiated at 0·6 mg per day and escalated by 0·6 mg per week]) or matching placebo group (equal injection volume and escalation schedule to active treatment group) using a block size of 56. All treatment doses were delivered once-daily via subcutaneous injections. Participants and investigators were masked to the assigned study treatment but not the target dose. The primary endpoint was percentage weight loss at week 52. The primary analysis was done using intention-to-treat ANCOVA estimation with missing data derived from the placebo pool. This study is registered with ClinicalTrials.gov, number NCT02453711. Findings Between Oct 1, 2015, and Feb 11, 2016, 957 individuals were randomly assigned (102–103 participants per active treatment group and 136 in the pooled placebo group). Mean baseline characteristics included age 47 years, bodyweight 111·5 kg, and BMI 39·3 kg/m 2. Bodyweight data were available for 891 (93%) of 957 participants at week 52. Estimated mean weight loss was −2·3% for the placebo group versus −6·0% (0·05 mg), −8·6% (0·1 mg), −11·6% (0·2 mg), −11·2% (0·3 mg), and −13·8% (0·4 mg) for the semaglutide groups. All semaglutide groups versus placebo were significant (unadjusted p≤0·0010), and remained significant after adjustment for multiple testing (p≤0·0055). Mean bodyweight reductions for 0·2 mg or more of semaglutide versus liraglutide were all significant (−13·8% to −11·2% vs −7·8%). Estimated weight loss of 10% or more occurred in 10% of participants receiving placebo compared with 37–65% receiving 0·1 mg or more of semaglutide (p

Introduction In the US, obesity rates are higher in rural areas than in urban areas. Rural access to treatment of obesity is limited by a lack of qualified clinicians and by transportation and financial barriers. We describe a telemedicine weight management programme, Wellness Connect, developed through a partnership of academic clinicians and rural primary care providers in South Carolina, and present utilisation and weight outcomes from seven patient cohorts. Methods Eight bi-weekly sessions were provided via telemedicine videoconferencing for groups of patients at these rural primary care clinics. Protocol-based sessions were led by registered dietitians, exercise physiologists and clinical psychologists at a central urban location. Results Of 138 patients who started the programme, 62% ( N = 86) of patients met the criteria for completion. Completers lost an average of 3.5% (standard deviation (SD) = 3.9%) body weight, which was statistically significant ( p Discussion The use of innovative telemedicine interventions continues to be necessary to alleviate barriers to accessing evidence-based services to reduce chronic diseases and decrease obesity rates among rural populations.

OBJECTIVE To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100–125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140–199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7–6.4% (39–46 mmol/mol). RESULTS A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 60 (9.9) years and BMI 32.1 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

Objective Focusing on average weight loss (WL) from interventions provides useful efficacy data but masks large variability across patients. In this study, parameters of weight loss trajectories were determined that differentiated individuals during a 15-week clinical lifestyle intervention. Methods Patients (n = 595) were in a fee-for-service WL lifestyle program with a partial meal replacement diet and lifestyle change counseling. Parameters used in latent class analyses were percent WL (%WL), weight nadir, number of weekly weight gains, maximum weekly percent weight gain, standard deviation of weekly weight changes, linear slope values, and change in slope. Results Average %WL was 9.73%. Latent class analyses revealed three groups with considerable overlap in %WL ranges but differing significantly on all trajectory parameters (Ps

Objective ACTION (Awareness, Care, and Treatment in Obesity maNagement) examined obesity-related perceptions, attitudes, and behaviors among people with obesity (PwO), health care providers (HCPs), and employer representatives (ERs). Methods A total of 3,008 adult PwO (BMI ≥ 30 by self-reported height and weight), 606 HCPs, and 153 ERs completed surveys in a cross-sectional design. Results Despite several weight loss (WL) attempts, only 23% of PwO reported 10% WL during the previous 3 years. Many PwO (65%) recognized obesity as a disease, but only 54% worried their weight may affect future health. Most PwO (82%) felt “completely” responsible for WL; 72% of HCPs felt responsible for contributing to WL efforts; few ERs (18%) felt even partially responsible. Only 50% of PwO saw themselves as “obese,” and 55% reported receiving a formal diagnosis of obesity. Despite HCPs' reported comfort with weight-related conversations, time constraints deprioritized these efforts. Only 24% of PwO had a scheduled follow-up to initial weight-related conversations. Few PwO (17%) perceived employer-sponsored wellness offerings as helpful in supporting WL. Conclusions Although generally perceived as a disease, obesity is not commonly treated as such. Divergence in perceptions and attitudes potentially hinders better management. This study highlights inconsistent understanding of the impact of obesity and need for both self-directed and medical management.

Aims Type 2 diabetes mellitus (T2DM) can substantially decrease quality of life (QOL). This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM. Methods A year-long multi-site randomized clinical trial compared the Weight Watchers (WW) approach, supplemented with phone and email counseling with a certified diabetes educator (CDE), to brief standard diabetes nutrition counseling and education (Standard Care; SC). Participants were 400 women and 163 men (N = 279 WW; 284 SC) with T2DM [mean (± SD) HbA1c 8.32 ± 1%; BMI = 37.1 ± 5.7 kg/m2; age = 55.1 ± 9.1 years]. Psychosocial outcomes were assessed at baseline, month 6, and month 12 using a diabetes specific psychosocial measure (Diabetes Distress Scale [DDS]), Impact of Weight on Quality of Life-Lite scale (IWQOL), a generic QOL measure (SF-36), and a depression screen (PHQ-9). Results WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function, sex life and work domains (all ps Conclusions WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity. Available commercial WL programs, combined with scalable complementary program-specific diabetes counseling, may have benefits that extend to diabetes-related distress and weight-relevant QOL.

Summary Objective Research suggests that individuals seeking weight loss treatment do so for a variety of reasons. Limited work has explored relations of reasons for weight loss to patient characteristics or to weight loss outcomes. The current study examined these relations. Methods The sample consisted of 588 patients in a 15‐week fee‐for‐service weight loss programme. Prior to the intervention, patients completed questionnaires including items on reasons for weight loss, demographic characteristics, and a variety of weight‐based characteristics. Patients' weight change outcomes were expressed as percent weight loss and also categorized into one of three previously described weight loss trajectories. Results The results of chi‐squared and t‐test analyses suggested that endorsement of health concerns, mobility concerns, or another person's recommendation was associated with higher body mass index (BMI) and older age. These reasons were more likely to be endorsed by White patients than Black patients and by male patients than female patients. Endorsement of doctor recommendation was more likely to be seen among Black patients than White patients. There was no significant relation of any weight loss reason with weight loss outcome. Conclusions While certain reasons for weight loss were more often cited by certain patient groups, no specific reason predicted a better or worse outcome.

Objective Modest weight loss from clinical interventions improves glycemic control in type 2 diabetes (T2DM). Data are sparse on the effects of weight loss via commercial weight loss programs. This study examined the effects on glycemic control and weight loss of the standard Weight Watchers program, combined with telephone and email consultations with a certified diabetes educator (WW), compared with standard diabetes nutrition counseling and education (standard care, SC). Methods In a 12-month randomized controlled trial at 16 U.S. research centers, 563 adults with T2DM (HbA1c 7–11%; BMI 27–50 kg/m2) were assigned to either the commercially available WW program (regular community meetings, online tools), plus telephone and email counseling from a certified diabetes educator, or to SC (initial in-person diabetes nutrition counseling/education, with follow-up informational materials). Results Follow-up rate was 86%. Twelve-month HbA1c changes for WW and SC were −0.32 and +0.16, respectively; 24% of WW versus 14% of SC achieved HbA1c

Objective To identify an early response criterion for predicting ≥5% weight loss with liraglutide 3.0 mg at week 56 and to compare efficacy outcomes in early responders (ERs) and early nonresponders (ENRs). Methods Using pooled data from the SCALE Obesity and Prediabetes and SCALE Diabetes trials, weight loss of ≥4% at 16 weeks best predicted ≥5% weight loss after 56 weeks. Weight loss and changes in cardiometabolic risk factors and health-related quality of life were evaluated in ERs (≥4% weight loss at week 16) and ENRs (10%, and >15% weight loss at week 56 with liraglutide 3.0 mg. Greater improvements in cardiometabolic risk factors and health-related quality of life scores were observed in ERs versus ENRs. Conclusions The early response criterion was clinically useful to identify individuals who would achieve clinically meaningful weight loss at 56 weeks.

Scarce data exist on pharmacotherapy for obesity in Hispanic individuals. This post hoc analysis of pooled data from 4 phase 3a trials compared the efficacy and safety of liraglutide 3.0 mg versus placebo, as adjunct to a reduced-calorie diet and physical activity, in Hispanic versus non-Hispanic subgroups.We conducted the double-blind randomized, placebo-controlled trials in adults with a minimum body mass index (BMI) of 27 kg/mBoth subgroups achieved clinically significant mean weight loss at end-of-treatment with liraglutide 3.0 mg versus placebo: Hispanics 7.0% versus 1.5%, treatment difference -5.1% (95% CI, -6.2 to -4.0); non-Hispanics 7.5% versus 2.3%, -5.2% (95% CI, -5.5 to -4.8). More individuals in both subgroups lost ≥5%,10%, and15% of their baseline weight with liraglutide 3.0 mg than with placebo. Efficacy endpoints generally did not vary with ethnicity (P.05). Adverse events were comparable between ethnic subgroups, with more gastrointestinal disorders reported with liraglutide 3.0 mg than placebo.Efficacy and safety were largely similar between Hispanic and non-Hispanic subgroups. Results support that liraglutide 3.0 mg, used with a reduced-calorie diet and physical activity, can facilitate weight loss in Hispanic individuals.A1c = glycated hemoglobin BMI = body mass index CI = confidence interval FPG = fasting plasma glucose GLP-1 = glucagon-like peptide-1 hsCRP = high-sensitivity C-reactive protein SCALE = Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes T2DM = type 2 diabetes mellitus.

Obesity is one of the main risk factors for type 2 diabetes (T2D), representing a major worldwide health crisis. Modest weight-loss (≥ 5% but

Objective To identify an early treatment milestone that optimizes sensitivity and specificity for predicting ≥5% weight loss at Week (W) 52 in patients with and without type 2 diabetes on lorcaserin or placebo. Methods Post hoc area under the curve for receiver operating characteristic analyses of data from three phase 3 trials comparing lifestyle modification+placebo with lifestyle modification+lorcaserin. A total of 6897 patients (18–65 years; BMI, 30–45 or 27–29.9 kg/m2 with ≥1 comorbidity) were randomized to placebo or lorcaserin 10 mg bid. Changes (baseline to W52) in cardiometabolic parameters were assessed. Results Response (≥5% weight loss from baseline) at W12 was a strong predictor of W52 response. Lorcaserin patients with a W12 response achieved mean W52 weight losses of 10.6 kg (without diabetes) and 9.3 kg (with diabetes). Proportions achieving ≥5% and ≥10% weight loss at W52 were 85.5% and 49.8% (without diabetes), and 70.5% and 35.9% (with diabetes). Lorcaserin patients who did not achieve a W12 response lost 3.2 kg (without diabetes) and 2.8 kg (with diabetes) at W52. Responders had greater improvements in cardiometabolic risk factors than the modified intent-to-treat (MITT) population, consistent with greater weight loss. Conclusions ≥5% weight loss by W12 predicts robust response to lorcaserin at 1 year.

OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D(3)) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100–125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140–199 mg/dL, and/or a hemoglobin A(1c) (HbA(1c)) 5.7–6.4% (39–46 mmol/mol). RESULTS: A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m(2). Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA(1c) criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA(1c) criteria only. Black participants had the highest mean HbA(1c) and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA(1c) and FPG concentrations. CONCLUSIONS: D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

Objective While overall success rates of bariatric surgery are high, approximately 20% of patients either regain or never lose the expected amount of weight. The purpose of this study was to determine whether, after gastric-bypass surgery, the degree of weight loss can be differentiated based on the neural response to food cues. Design and Methods In this functional MRI study, 31 post-surgical patients viewed food and neutral images in two counterbalanced runs during which they were either instructed to “crave” or to “resist” craving. The neural response to food cues was assessed within and between runs for all participants, and further analyzed between more successful (n = 24) and less successful (n = 7) groups. More successful was defined by meeting 50% excess weight loss. Results Overall, instructions to “crave” elicited significant activity in the dorsomedial prefrontal cortex (PFC) whereas “resist” elicited significant activity in the dorsolateral PFC (DLPFC). Between groups there was no brain difference when instructed to “crave.” The more successful participants however had significantly more activity in the DLPFC when instructed to “resist.” Conclusions These findings suggest that the ability to mobilize neural circuits involved in executive control post-gastric-bypass surgery may be a unique component of successful outcome post-surgery.

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.

Obesity is a world-wide epidemic associated with significant morbidity and mortality which costs billions of dollars per year. The associated related conditions are many and include heart disease, stroke, type II diabetes mellitus, sleep apnea and certain types of cancer. Given that it is a multifactorial problem, the treatments must also address the numerous causes associated with the development of obesity. The neurohormonal regulation of feeding and energy is a complex system often necessitating modification through more than 1 pathway to achieve weight loss. Therefore, in addition to lifestyle changes, attenuation of caloric intake and increase in caloric expenditure, pharmacotherapies, including combination medications, may prove beneficial in its treatment. Adding to the current available pharmacotherapies for obesity, the Food and Drug Administration has recently approved 2 new combination medications known as lorcaserin (Belviq) and phentermine-topiramate (Qsymia). As with these and other medications used for weight loss, clinical cautions, side effects, precise review of patients’ medical history and selecting the appropriate medication are imperative. Additionally, close follow-up is necessary in patients undergoing treatment for weight loss. As weight loss progresses, patients who are currently undergoing concomitant treatment for comorbid diabetes and hypertension need to be monitored for appropriate changes in medications used to treat those conditions. Weight loss is often accompanied by improvement in blood pressure and glucose levels and therefore resting blood pressure and fasting and/or postprandial plasma glucose levels should be monitored at follow-up. Although unique to each individual, the benefits of weight loss are substantial and can improve well-being and physical health.

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.

Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N = 111, body mass index M ± SD = 31.5 ± 2.7 kg/m2) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control.

Little is known about the cardiovascular effects of modest weight loss. To determine whether weight losses limited to 5–10 % are sufficient to produce cardiovascular health benefits, data from 401 overweight and obese adults who enrolled in a behavioral weight loss program from 2003 to 2011 were analyzed. Primary outcomes were changes in fasting glucose, triglycerides, and cholesterol. Patients who lost 5–10 % showed significant reductions in triglycerides, total cholesterol, and low-density lipoprotein (LDL) cholesterol. Patients who lost >10 % experienced significantly greater improvements in triglycerides, total cholesterol, and LDL cholesterol than patients losing less. For higher-risk patients, those who lost 5–10 % significantly reduced fasting glucose, triglycerides, and total cholesterol; those who lost >10 % improved on all risk factors (except HDL cholesterol) and to a significantly greater degree than those losing less. Five to 10 % weight losses produced improvements in cardiovascular risk factors, but greater weight losses were associated with even greater improvement.

Objective: Studies of birth patterns in anorexia nervosa have shown relative increases between March and August, while studies in Bulimia Nervosa (BN) have been negative. Since there are no studies using representative, nonclinical samples, we looked for seasonal birth patterns in women with BN and in those who ever endorsed bingeing or purging. Method: A national, representative sample of 3,006 adult women completed structured telephone interviews including screenings for bulimia nervosa (BN) and questions about month, date, and year of birth. Season of birth was calculated using traditional definitions. Differences across season of birth between subjects with (n = 85) and without BN (n = 2,898), those with (n = 749) and without bingeing (n = 2,229), and those with (n = 267) and without any purging (n = 2,715) were compared using chi-square analyses. Results: There were significant differences across season of birth between subjects: (1) with and without BN (p = 0.033); (2) with and without bingeing (p = 0.034), and; (3) with and without purging (p = 0.001). Fall had the highest relative number of births for all categories, while spring had the lowest. Discussion: In a national representative study of nontreatment seeking subjects significant differences in season of birth were found for subjects with lifetime histories of BN, binge eating and purging. © 2011 by Wiley Periodicals, Inc. (Int J Eat Disord 2012)

This 56-week, randomized, placebo-controlled trial examined the efficacy and safety of naltrexone plus bupropion as an adjunct to intensive behavior modification (BMOD). A total of 793 participants (BMI = 36.5 ± 4.2 kg/m2) was randomly assigned in a 1:3 ratio to: (i) placebo + BMOD (N = 202); or (ii) naltrexone sustained-release (SR, 32 mg/day), combined with bupropion SR (360 mg/day) plus BMOD (i.e., NB32 + BMOD; N = 591). Both groups were prescribed an energy-reduced diet and 28 group BMOD sessions. Co-primary end points were percentage change in weight and the proportion of participants who lost ≥5% weight at week 56. Efficacy analyses were performed on a modified intent-to-treat population (ITT; i.e., participants with ≥1 postbaseline weight while taking study drug (placebo + BMOD, N = 193; NB32 + BMOD, N = 482)). Missing data were replaced with the last observation obtained on study drug. At week 56, weight loss was 5.1 ± 0.6% with placebo + BMOD vs. 9.3 ± 0.4% with NB32 + BMOD (P < 0.001). A completers analysis revealed weight losses of 7.3 ± 0.9% (N = 106) vs. 11.5 ± 0.6% (N = 301), respectively (P < 0.001). A third analysis, which included all randomized participants, yielded losses of 4.9 ± 0.6 vs. 7.8 ± 0.4%, respectively (P < 0.001). Significantly more NB32 + BMOD- vs. placebo + BMOD-treated participants lost ≥5 and ≥10% of initial weight, and the former had significantly greater improvements in markers of cardiometabolic disease risk. NB32 + BMOD was generally well tolerated, although associated with more reports of nausea than placebo + BMOD. The present findings support the efficacy of combined naltrexone/bupropion therapy as an adjunct to intensive BMOD for obesity.

Existing obesity therapies are limited by safety concerns and modest efficacy reflecting a weight loss plateau. Here, we explore combination therapy with bupropion (BUP), a putative stimulator of melanocortin pathways, and an opioid antagonist, naltrexone (NAL), to antagonize an inhibitory feedback loop that limits sustained weight reduction. In vitro electrophysiologic experiments were conducted to determine the extent to which BUP+NAL stimulated hypothalamic pro-opiomelanocortin (POMC) neurons in mouse brain. A subsequent study further characterized the effect of combination BUP+NAL treatment on food intake in lean and obese mice. Finally, a randomized, blinded, placebo-controlled trial in obese adult subjects was conducted. Randomization included: BUP (300 mg) + NAL (50 mg), BUP (300 mg) + placebo (P), NAL (50 mg) + P or P+P for up to 24 weeks. BUP+NAL stimulated murine POMC neurons in vitro and caused a greater reduction in acute food intake than either monotherapy, an effect consistent with synergism. Combined BUP+NAL provided sustained weight loss without evidence of an efficacy plateau through 24 weeks of treatment. BUP+NAL completers diverged from NAL+P (P < 0.01) and P+P (P < 0.001) at week 16 and from BUP+P by week 24 (P < 0.05). The combination was also well tolerated. Translational studies indicated that BUP+NAL therapy produced synergistic weight loss which exceeded either BUP or NAL alone. These results supported the hypothesis that NAL, through blockade of β-endorphin mediated POMC autoinhibition, prevents the classic weight loss plateau observed with monotherapies such as BUP. This novel treatment approach (BUP+NAL) holds promise for the treatment of obesity.

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.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.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 losingor =10% of initial body weight.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.

Approved for treatment of treatment-resistant depression and for epilepsy, vagus nerve stimulation (VNS) therapy involves stimulation of the vagus nerve, affecting both mood and appetite regulating systems. VNS is associated with changes in food intake and weight loss in animals. Studies of its impact on food intake and weight with humans are limited. It is not known whether or how VNS influences emotional response to food, but vagus afferents project to regions in the insula involving satiety and taste.Thirty-three participants were recruited for three groups: depressed patients undergoing VNS therapy, depressed patients not undergoing VNS therapy, and healthy controls. All participants viewed images of foods twice in random order. When applicable, VNS devices were turned on for one viewing and off for the other. Participants were instructed to rate immediately after the viewings how each picture made them feel on a visual analog on three dimensions (unhappy to happy, calm to aroused, and small/submissive to big/domineering).Controlling for time since last meal, a significant main effect was found for arousal ratings in response to sweet food images. Post-hoc analyses indicated that the VNS group demonstrated significant changes in arousal ratings between paired food image viewings compared to controls. Sixty-four percent of VNS participants demonstrated increases and 36% demonstrated decreases in arousal. Higher body mass indexes and greater levels of self-reported sweet cravings were associated with increased arousal during VNS activation.This study was the first to examine the effects of acute left cervical VNS on emotional ratings of food in adults with major depression. Results suggest that VNS device activation may be associated with acute alteration in arousal response to sweet foods among depressed patients. Future research is needed to replicate these findings and to assess how activation of the vagus nerve affects eating and weight.

Objective: To evaluate whether MK-0557, a highly selective, orally administered neuropeptide Y Y5 receptor antagonist, could limit weight regain after very-low-calorie diet (VLCD)-induced weight loss. Research Methods and Procedures: We enrolled 502 patients 18 to 65 years of age with a BMI of 30 to 43 kg/m2. Patients were placed on a VLCD (800 kcal/d liquid diet) for 6 weeks. Patients who lost ≥6% of initial body weight (n = 359) were randomized to 52 weeks of 1 mg/d MK-0557 or placebo and maintained on a hypocaloric diet (300 kcal below weight maintenance requirements). Results: In randomized patients, the VLCD was associated with an average weight loss of 9.1 kg. After 12 weeks of double-blind treatment, weight began to gradually increase for both placebo- and MK-0557-treated patients. The mean weight change (95% confidence interval) from baseline at the end of the VLCD to Week 52 was +3.1 (2.1, 4.0) and +1.5 (0.5, 2.4) kg for patients treated with placebo and MK-0557, respectively. The difference of 1.6 kg between the two groups was significant (p = 0.014). Secondary endpoints, such as blood pressure, lipid profile, insulin, and leptin, as well as waist circumference and quality-of-life measurements, did not show significant differences between MK-0557 and placebo treatments. Discussion: Although the difference in weight regain between placebo- and MK-0557-treated patients was statistically significant, the magnitude of the effect was small and not clinically meaningful. Antagonism of the neuropeptide Y Y5 receptor is not an efficacious treatment strategy for reducing weight regain after VLCD.

Vagus nerve stimulation (VNS) is now available as a treatment for epilepsy and treatment-resistant depression. The vagus nerve plays a central role in satiety and short-term regulation of food intake and research suggests a relationship between VNS and weight loss. The underlying mechanisms of this relationship are unknown. The purpose of the current study was to determine whether acute cervical VNS might temporarily alter food cravings. Thirty-three participants were recruited for three groups; depression VNS, depression non-VNS, and healthy controls. Participants viewed 22 computerized images of foods twice in one session and completed ratings for food cravings after each image. The VNS participants' devices were turned on for one viewing of an image and off for the other (randomized order). Participants were blind to VNS condition (on versus off). Acute VNS device activation was associated with a significant change in cravings-ratings for sweet foods. A significant proportion of variability in VNS-related changes in cravings was accounted for by patients' clinical VNS device settings, acute level of depression, and body mass. Further studies are warranted addressing how acute or chronic VNS might modify eating behavior and weight.

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.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).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.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.

The number of different types of purging behaviors (NPB) of subjects with bulimia nervosa (BN) has been associated with greater severity of illness and psychiatric comorbidity. No studies have examined the association between the NPB used (vomiting, laxative abuse, diuretic abuse), histories of trauma, and post-traumatic stress disorder (PTSD). A national, representative sample of 3,006 adult women (≥18 years) completed a structured telephone interview including screenings for victimization experiences, PTSD, BN, major depression (MD), alcohol abuse (AA), and alcohol dependence (AD). Significant relationships were found between the NPB used and lifetime rates of victimization, PTSD, MD, AA, AD, and total comorbid disorders (p ≤ .001, χ(2)).

MARTIN, CORBY K., PATRICK M. O’NEIL, AND LAURA PAWLOW. Changes in food cravings during lowcalorie and very-low-calorie diets. Obesity. 2006;14: 115–121. Objective: This study examined food cravings during a primarily food-based low-calorie diet (LCD) and a supplement-based very-LCD (VLCD). Research Methods and Procedures: The Food Craving Inventory (FCI) was used to measure general cravings and cravings for specific types of foods (sweets, high fats, carbohydrates/starches, and fast food fats). The FCI was completed by participants in the LCD and VLCD programs at baseline and after 11 weeks of dieting. The VLCD group also completed the FCI at Week 6 and after 5 weeks of a refeeding phase, when their diet consisted primarily of solid food. Results: From baseline to Week 12, craving decreases were greater for the VLCD group than for the LCD group on all measures. All craving measures decreased significantly for the VLCD group. The LCD group experienced a marginally significant decrease in sweet cravings. Within the VLCD group, all craving measures decreased significantly by Week 6 and did not change thereafter, including after resumption of solid food intake, and craving scores during all dieting points were lower than baseline. Changes in cravings were not related to weight loss. Discussion: Cravings did not increase during either diet; all changes represented decreases. Compared with a primarily food-based diet (LCD), a more restrictive supplement-based diet (VLCD) resulted in significantly larger decreases in food cravings that occurred by the end of the 5th week of supplement use and did not rebound with resumption of solid food intake. The results of this study suggest that food cravings diminish with calorie restriction.

Background Among severely obese persons seeking surgical treatment, lifetime prevalence rates of Axis 1 psychiatric disorders range up to 50%; 27% to 42% have a diagnosable psychiatric disorder at the time of evaluation. Despite recommendations by the National Institutes of Health Consensus Development Panel that evaluation for surgery include a mental health component, little data are available on the outcomes of such evaluations. Similarly, there are also few data on the frequency and type of psychotropic medication use by these patients. The primary objective of this study was to describe the recommendations resulting from psychological evaluations of bariatric surgery applicants; a secondary purpose was to describe the point and lifetime prevalences of psychotropic medication use. Methods We examined the psychological evaluation recommendations of successive gastric bypass applicants at the Medical University of South Carolina. Results Results indicated that the overwhelming majority (81.5%) of gastric bypass applicants had no psychological contraindication to surgery. A smaller percentage (15.8%) required psychological treatment before surgery, and only 2.7% of all applicants were considered psychologically inappropriate for surgery. Results also indicate that 47.7% were using at least 1 psychotropic medication at the time of the evaluation, and that 9.2% were using more than 1. The overwhelming majority of medications used were antidepressants, followed by antianxiety medications and mood stabilizers. Conclusions These results indicate that the vast majority of patients will not be denied surgery as the result of a psychological assessment, yet approximately 20% of patients may be considered, based on psychological evaluation, psychologically inappropriate for immediate surgery, at least without initial treatment. These data also suggest that pharmacologic treatment of psychiatric disorders is quite common among gastric bypass applicants.

To examine the characteristics and outcomes of physician-referred weight management patients relative to self-referred patients.Review of clinic records of all individuals contacting a weight control program during a 2-year period with follow-up throughout consecutive levels of treatment (i.e., enrollment, completion, and outcome).Medical school weight management center.A consecutive sample (N = 1,392) of overweight and obese callers was categorized as physician-initiated (n = 345), media (n = 653), or personal (n = 394) referrals. Attendees at initial consultation (n = 571) were age 41.7 +/- 12.8 years, weight 113.9 +/- 36.1 kilograms, and body mass index (BMI) 40.3 +/- 11.3 kg/m(2) (data expressed as mean +/- standard deviation).Low-calorie-diet and very-low-calorie-diet programs.Gender comparisons, attendance at initial consultation, body mass index, motivation, comorbidities, enrollment and completion rates, and weight loss.Compared to callers from other referral sources, physician referrals included a larger minority of males (25.2%) and were more likely to attend an initial consultation (63.5%; P.001). Among consultation attendees, physician referrals were heavier (mean BMI = 44.8), reported more comorbidities, were less likely to join programs (16.9%), and scored as less motivated than other referrals (P.007). Completion rates for physician referrals were higher than for self-referrals in the very-low-calorie-diet program (85.7%; P.04) but not in the low-calorie-diet program (P.05). Among completers, physician referrals did not differ on weight loss in either program (P.05).Compared to self-referrals, physician-referred individuals are in greater need of weight loss, less motivated, less likely to enter treatment, but equally likely to profit from it. Therefore, physician referral for weight loss is beneficial for at least some patients and should be encouraged.

Obesity, a primary health concern worldwide, results in increased rates of chronic disease and mortality. Despite an urgent need for creative solutions to the obesity epidemic, human factors and ergonomics professionals have yet to apply their skill sets to solving this global problem. The present study evaluates the “Bite Counter”, a wrist-worn device that can detect when an individual takes a bite of food. The usability and acceptability of the bite counter will be examined during a weight loss trial. Understanding user difficulties that lead to decreased user compliance will result in guidelines for improving future iterations of the device and future weight loss trials with the Bite Counter.

Objective: Studies of age of first binge have been conducted in clinical samples of patients with bulimia nervosa (BN) and binge eating disorder (BED), but few studies have examined age of first binge using nationally representative samples. Method: We examined age of first binge and its clinical correlates using data generated from the National Women’s Study (n 53,006). Participants who endorsed ever binge eating (n 5707) were divided into two groups: (1) child-adolescent onset (CO)—age of fi rst binge

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 Ibs) 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.

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 ≥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 I y in combination with a maintenance diet to help prevent weight regain. Of 1313 recruited subjects [body mass index (in kg/m 2 ): 28-43], 729 subjects lost ≥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 ≤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.

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.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).289 treatment-seeking obese women (age: 40.9 y, body mass index (BMI): 34.7 kg/m2).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.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.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.

This study examined the relations between stable moods (i.e., non clinical levels of anxiety and depression) and average daily intake of certain macro- and micronutrients, among a sample of obese women. Subjects were 38 women assessed at entry to a long-term weight-loss medication trial. Subjects' levels of anxiety and depression were assessed by self-report measures and by a psychiatrist's ratings. Average daily intakes of energy, macronutrients, certain micronutrients, and caffeine were computer analyzed (Nutritionist III) from subjects' eating diaries. Results were analyzed via Pearson correlation coefficients and multiple regression analyses. Higher carbohydrate (CHO) intake, particularly simple CHO intake, was consistently related to lower levels of both anxiety and depression. Some relations of mood to caffeine and micronutrients were also observed on correlational analyses. Discussion examines possible explanations for findings, particularly the surprisingly strong association between higher intakes of simple CHO and lower levels of depression and anxiety.