BACKGROUND Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices. METHODS We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss. RESULTS Of the 390 participants, 86% completed the 2-year trial, at which time, the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P = 0.003 and P = 0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events. CONCLUSIONS Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss. (Funded by the National Heart, Lung, and Blood Institute; POWER-UP ClinicalTrials.gov number, NCT00826774.)

The increasing prevalence of obesity has become one of the most challenging problems facing healthcare providers. Despite recommendations from the U.S. Preventive Services Task Force many health professionals fail to discuss obesity with their patients. This study sought to identify terms that individuals with obesity and being treated in primary care find the most and least acceptable for describing their excess weight. Three-hundred ninety obese adult primary care patients in the Philadelphia area were administered the Weight Preferences Questionnaire from January 2008 through February 2009. Ratings of 11 terms used to describe excess weight were transformed to a five-point scale, ranging from “very desirable” (+2) to neutral (0) to “very undesirable” (-2). The term “fatness” (mean score -1.1 ± 1.3) was rated as significantly more undesirable than all other descriptors (p < 0.001). The terms “excess fat” (-0.6 ± 1.3), “large size” (-0.6 ± 1.3), “obesity” (-0.5 ± 1.4), and “heaviness” (-0.4 ± 1.2) were rated as significantly more undesirable then the remaining terms, which included weight problem, body mass index (BMI), and excess weight (p<0.001). In contrast, the term “weight” was viewed as the most desirable term for characterizing excess weight. Patients' preferences for terms were not significantly influenced by gender, race/ethnicity, or a BMI ≥ 40 kg/m2. Practitioners who treat obesity are encouraged to avoid undesirable terms when discussing this condition with their patients. Instead practitioners may want to consider broaching the topic using more patient-friendly term such as “weight,” “BMI,” “weight problem,” or excess weight.”

The prevalence of prehypertension and Stage 1 hypertension continues to increase despite being amenable to non-pharmacologic interventions. Iyengar yoga (IY) has been purported to reduce blood pressure (BP) though evidence from randomized trials is lacking. We conducted a randomized controlled trial to assess the effects of 12 weeks of IY versus enhanced usual care (EUC) (based on individual dietary adjustment) on 24-h ambulatory BP in yoga-naïve adults with untreated prehypertension or Stage 1 hypertension. In total, 26 and 31 subjects in the IY and EUC arms, respectively, completed the study. There were no differences in BP between the groups at 6 and 12 weeks. In the EUC group, 24-h systolic BP (SBP), diastolic BP (DBP) and mean arterial pressure (MAP) significantly decreased by 5, 3 and 3 mmHg, respectively, from baseline at 6 weeks (P < .05), but were no longer significant at 12 weeks. In the IY group, 24 h SBP was reduced by 6 mmHg at 12 weeks compared to baseline (P = .05). 24 h DBP (P < .01) and MAP (P < .05) decreased significantly each by 5 mmHg. No differences were observed in catecholamine or cortisol metabolism to explain the decrease in BP in the IY group at 12 weeks. Twelve weeks of IY produces clinically meaningful improvements in 24 h SBP and DBP. Larger studies are needed to establish the long term efficacy, acceptability, utility and potential mechanisms of IY to control BP.

Objective This study investigated changes in quality of life in men and women who participated in a primary care-based weight loss intervention. Methods Participants were enrolled in a two-year randomized clinical trial (POWER-UP) conducted at the University of Pennsylvania and six affiliated primary care practices. Inclusion criteria included the presence of obesity (body mass index of 30–50 kg/m2) and at least two components of the metabolic syndrome. Main Outcome Measures Quality of life was assessed by three measures: Short Form (12) Health Survey (SF-12); Impact of Weight on Quality of Life-Lite (IWQOL-Lite); and the EuroQol-5D. Results Six months after the onset of treatment, and with a mean weight loss of 3.9 ± .30 kg, participants reported significant improvements on all of the measures of interest with the exception of the Mental Component Score of the SF-12. These changes remained significantly improved from baseline at month 24, with the exception of the EuroQol-5D. Many of these improvements were correlated with the magnitude of weight loss and, for the most part, were consistent across gender and race. Conclusion Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of quality of life with a modest weight loss of 3.7% of initial weight, achieved within the first 6 months of treatment. The majority of these improvements were maintained at month 24, when participants had lost 3.0% of their weight.

Background Ustekinumab is currently approved globally in Crohn’s disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn’s disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses. Methods Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed. Results Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81–176.67] vs ustekinumab 118.32 [95% CI, 113.25–123.55]), serious AEs (27.50 [95% CI, 23.45–32.04] vs 21.23 [95% CI, 19.12–23.51]), infections (80.31 [95% CI, 73.28–87.84] vs 64.32 [95% CI, 60.60–68.21]), serious infections (5.53 [95% CI, 3.81–7.77] vs 5.02 [95% CI, 4.02–6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00–0.93] vs 0.40 [95% CI, 0.16–0.83]) were similar between placebo and ustekinumab. Conclusions The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications. ClinicalTrials.gov numbers NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.