Abstract Objective To evaluate the effectiveness of the Shaping Healthy Choices Program (SHCP). Design A clustered, randomized, controlled intervention lasting 1 school year. Setting Schools in ...northern and central California. Participants Fourth-graders (aged 9–10 years) at 2 control schools (n = 179) and 2 intervention schools (n = 230). Intervention Garden-enhanced education, family, and community partnerships; increased regionally procured produce in the lunchroom; and school-site wellness committees. Main Outcome Measures Changes in body mass index (BMI) percentiles/Z-scores; nutrition knowledge, science process skills, and vegetable identification and preferences; and reported fruit and vegetable intake. Analysis Student t test, chi-square, ANOVA of change, and multilevel regression mixed model to evaluate change in outcomes with school as a random effect to account for cluster design effects. Statistical significance was set at P < .05. Results There was a greater improvement in BMI percentile (−6.08; P < 0.01), BMI Z-score (−0.28; P < .001), and waist-to-height ratio (−0.02; P < .001) in the intervention compared with the control schools. Conclusions and Implications The SHCP resulted in improvements in nutrition knowledge, vegetable identification, and a significant decrease in BMI percentiles. This supports the concept that the SHCP can be used to improve the health of upper elementary school students.
Objectives This study sought to report full 1-year results, detailed magnetic resonance imaging analysis, and determinants of efficacy in the prospective, randomized, controlled CADUCEUS ...(CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial. Background Cardiosphere-derived cells (CDCs) exerted regenerative effects at 6 months in the CADUCEUS trial. Complete results at the final 1-year endpoint are unknown. Methods Autologous CDCs (12.5 to 25 × 106 ) grown from endomyocardial biopsy specimens were infused via the intracoronary route in 17 patients with left ventricular dysfunction 1.5 to 3 months after myocardial infarction (MI) (plus 1 infused off-protocol 14 months post-MI). Eight patients were followed as routine-care control patients. Results In 13.4 months of follow-up, safety endpoints were equivalent between groups. At 1 year, magnetic resonance imaging revealed that CDC-treated patients had smaller scar size compared with control patients. Scar mass decreased and viable mass increased in CDC-treated patients but not in control patients. The single patient infused 14 months post-MI responded similarly. CDC therapy led to improved regional function of infarcted segments compared with control patients. Scar shrinkage correlated with an increase in viability and with improvement in regional function. Scar reduction correlated with baseline scar size but not with a history of temporally remote MI or time from MI to infusion. The changes in left ventricular ejection fraction in CDC-treated subjects were consistent with the natural relationship between scar size and ejection fraction post-MI. Conclusions Intracoronary administration of autologous CDCs did not raise significant safety concerns. Preliminary indications of bioactivity include decreased scar size, increased viable myocardium, and improved regional function of infarcted myocardium at 1 year post-treatment. These results, which are consistent with therapeutic regeneration, merit further investigation in future trials. (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction CADUCEUS; NCT00893360 )
Abstract Objective To provide a framework for implementation of multicomponent, school-based nutrition interventions. This article describes the research methods for the Shaping Healthy Choices ...Program, a model to improve nutrition and health-related knowledge and behaviors among school-aged children. Design Longitudinal, pretest/posttest, randomized, controlled intervention. Setting Four elementary schools in California. Participants Fourth-grade students at intervention (n = 252) and control (n = 238) schools and their parents and teachers. Power analyses demonstrate that a minimum of 159 students per group will be needed to achieve sufficient power. The sample size was determined using the variables of nutrition knowledge, vegetable preference score, and body mass index percentile. Intervention A multicomponent school-based nutrition education intervention over 1 academic year, followed by activities to support sustainability of the program. Main Outcome Measures Dietary and nutrition knowledge and behavior, critical thinking skills, healthy food preferences and consumption, and physical activity will be measured using a nutrition knowledge questionnaire, a food frequency questionnaire, a vegetable preferences assessment tool, the Test of Basic Science Process Skills, digital photography of plate waste, PolarActive accelerometers, anthropometrics, a parent questionnaire, and the School and Community Actions for Nutrition survey. Analysis Evaluation will include quantitative and qualitative measures. Quantitative data will use paired t , chi-square, and Mann-Whitney U tests and regression modeling using P = .05 to determine statistical significance.
Summary Background Cardiosphere-derived cells (CDCs) reduce scarring after myocardial infarction, increase viable myocardium, and boost cardiac function in preclinical models. We aimed to assess ...safety of such an approach in patients with left ventricular dysfunction after myocardial infarction. Methods In the prospective, randomised CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction (CADUCEUS) trial, we enrolled patients 2–4 weeks after myocardial infarction (with left ventricular ejection fraction of 25–45%) at two medical centres in the USA. An independent data coordinating centre randomly allocated patients in a 2:1 ratio to receive CDCs or standard care. For patients assigned to receive CDCs, autologous cells grown from endomyocardial biopsy specimens were infused into the infarct-related artery 1·5–3 months after myocardial infarction. The primary endpoint was proportion of patients at 6 months who died due to ventricular tachycardia, ventricular fibrillation, or sudden unexpected death, or had myocardial infarction after cell infusion, new cardiac tumour formation on MRI, or a major adverse cardiac event (MACE; composite of death and hospital admission for heart failure or non-fatal recurrent myocardial infarction). We also assessed preliminary efficacy endpoints on MRI by 6 months. Data analysers were masked to group assignment. This study is registered with ClinicalTrials.gov , NCT00893360. Findings Between May 5, 2009, and Dec 16, 2010, we randomly allocated 31 eligible participants of whom 25 were included in a per-protocol analysis (17 to CDC group and eight to standard of care). Mean baseline left ventricular ejection fraction (LVEF) was 39% (SD 12) and scar occupied 24% (10) of left ventricular mass. Biopsy samples yielded prescribed cell doses within 36 days (SD 6). No complications were reported within 24 h of CDC infusion. By 6 months, no patients had died, developed cardiac tumours, or MACE in either group. Four patients (24%) in the CDC group had serious adverse events compared with one control (13%; p=1·00). Compared with controls at 6 months, MRI analysis of patients treated with CDCs showed reductions in scar mass (p=0·001), increases in viable heart mass (p=0·01) and regional contractility (p=0·02), and regional systolic wall thickening (p=0·015). However, changes in end-diastolic volume, end-systolic volume, and LVEF did not differ between groups by 6 months. Interpretation We show intracoronary infusion of autologous CDCs after myocardial infarction is safe, warranting the expansion of such therapy to phase 2 study. The unprecedented increases we noted in viable myocardium, which are consistent with therapeutic regeneration, merit further assessment of clinical outcomes. Funding US National Heart, Lung and Blood Institute and Cedars-Sinai Board of Governors Heart Stem Cell Center.
Abstract Objective To examine the use of a systematic approach and theoretical framework to develop an inquiry-based, garden-enhanced nutrition curriculum for the Shaping Healthy Choices Program. ...Methods Curriculum development occurred in 3 steps: identification of learning objectives, determination of evidence of learning, and activity development. Curriculum activities were further refined through pilot-testing, which was conducted in 2 phases. Formative data collected during pilot-testing resulted in improvements to activities. Results Using a systematic, iterative process resulted in a curriculum called Discovering Healthy Choices , which has a strong foundation in Social Cognitive Theory and constructivist learning theory. Furthermore, the Backward Design method provided the design team with a systematic approach to ensure activities addressed targeted learning objectives and overall Shaping Healthy Choices Program goals. Conclusions and Implications The process by which a nutrition curriculum is developed may have a direct effect on student outcomes. Processes by which nutrition curricula are designed and learning objectives are selected, and how theory and pedagogy are applied should be further investigated so that effective approaches to developing garden-enhanced nutrition interventions can be determined and replicated.
To create evidence-based guidelines evaluating foot care interventions for the management of juvenile idiopathic arthritis (JIA).
An electronic literature search of the following databases from ...database inception to May 2015 was conducted: MEDLINE (Ovid), EMBASE (Ovid), Cochrane CENTRAL, and clinicaltrials.gov.
The Ottawa Panel selection criteria targeted studies that assessed foot care or foot orthotic interventions for the management of JIA in those aged 0 to ≤18 years. The Physiotherapy Evidence Database scale was used to evaluate study quality, of which only high-quality studies were included (score, ≥5). A total of 362 records were screened, resulting in 3 full-text articles and 1 additional citation containing supplementary information included for the analysis.
Two reviewers independently extracted study data (intervention, comparator, outcome, time period, study design) from the included studies by using standardized data extraction forms. Directed by Cochrane Collaboration methodology, the statistical analysis produced figures and graphs representing the strength of intervention outcomes and their corresponding grades (A, B, C+, C, C-, D+, D, D-). Clinical significance was achieved when an improvement of ≥30% between the intervention and control groups was present, whereas P>.05 indicated statistical significance. An expert panel Delphi consensus (≥80%) was required for the endorsement of recommendations.
All included studies were of high quality and analyzed the effects of multidisciplinary foot care, customized foot orthotics, and shoe inserts for the management of JIA. Custom-made foot orthotics and prefabricated shoe inserts displayed the greatest improvement in pain intensity, activity limitation, foot pain, and disability reduction (grades A, C+).
The use of customized foot orthotics and prefabricated shoe inserts seems to be a good choice for managing foot pain and function in JIA.
Introduction It is well established that children are exposed to food marketing promoting calorically dense, low-nutrient products. Reducing exposure to obesogenic marketing presents an opportunity ...to improve children’s health. The purpose of this study was to determine the extent to which televised food advertising practices targeting children (aged ≤12 years) were consistent with guidelines proposed by a coalition of federal authorities known as the Interagency Working Group on Foods Marketed to Children (IWG). Methods A sample of children’s TV programming aired on five national broadcast networks and two cable channels (N=103 shows) was recorded February to April 2013. The sample contained 354 food ads. Advertised products were identified and categorized using industry classification codes and nutrient data obtained from manufacturers. Product compliance with IWG saturated fat, trans fat, added sugar, and sodium guidelines was evaluated. Results Analyses conducted in 2013 revealed that nearly all food ads (94%) met guidelines for trans fats; 68% and 62% met guidelines for sodium and saturated fat, respectively; and 20% complied with added sugar guidelines. Overall, 1.4% of all child-targeted food ads met all aspects of IWG guidelines. Conclusions Nearly all food advertisements exceeded guidelines for at least one recommended nutrient to limit. Individually, conformity was high for guidelines for trans fats, moderate for sodium and saturated fats, and poor for added sugar. These findings suggest that child-targeted food advertising remains strongly biased toward less healthy options. Policymakers wishing to regulate food marketing should understand the amount and types of advertisements that children view.
Background Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on ...airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents. Objective We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough. Methods Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected. Results Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours 95% CI, +0.3 to +2.2; P = .0049 and +0.7 doubling doses at 24 hours 95% CI, +0.0 to +1.5; P = .0259). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498. Conclusion This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents.
Summary Background Evidence is scarce for the effectiveness of therapies for oesophageal cancer progressing after chemotherapy, and no randomised trials have been reported. We aimed to compare ...gefitinib with placebo in previously treated advanced oesophageal cancer. Methods For this phase 3, parallel, randomised, placebo-controlled trial, eligible patients were adults with advanced oesophageal cancer or type I/II Siewert junctional tumours, histologically confirmed squamous-cell carcinoma or adenocarcinoma, who had progressed after chemotherapy, with WHO performance status 0–2, and with measurable or evaluable disease on CT scan. Participants were recruited from 48 UK centres and randomly assigned (1:1) to gefitinib (500 mg) or matching placebo by simple randomisation with no stratification factors. Patients, clinicians, and trial office staff were masked to treatment allocation. Treatment continued until disease progression, unacceptable toxicity, or patient choice. The primary outcome was overall survival, analysed by intention to treat. This trial is registered, number ISRCTN29580179. Findings Between March 30, 2009, and Nov 18, 2011, 450 patients were randomly assigned to treatment groups (one patient withdrew consent; 224 patients allocated gefitinib and 225 allocated placebo included in analyses). Overall survival did not differ between groups (median 3·73 months, 95% CI 3·23–4·50, for gefitinib vs 3·67 months, 95% CI 2·97–4·37, for placebo; hazard ratio HR 0·90, 95% CI 0·74–1·09, p=0·29). Among the prespecified patient-reported outcomes (110 patients on gefitinib and 121 on placebo completed both baseline and 4 week questionnaires and were included in analyses), odynophagia was significantly better in the gefitinib group (adjusted mean difference −8·61, 95% CI −14·49 to −2·73; n=227; p=0·004), whereas the other outcomes were not significantly improved compared with placebo: global quality of life (2·69, 95% CI −2·33 to 7·72, n=231, p=0·293), dysphagia (−3·18, 95% CI −8·36 to 2·00, n=231, p=0·228), and eating (−4·11, 95% CI −9·96 to 1·75, n=229, p=0·168). Median progression-free survival was marginally longer with gefitinib than it was with placebo (1·57 months, 95% CI 1·23–1·90 in the gefitinib group vs 1·17 months, 95% CI 1·07–1·37 in the placebo group; HR 0·80, 95% CI 0·66–0·96, p=0·020). The most common toxicities were diarrhoea (36 16% of 224 patients on gefitinib vs six 3% of 225 on placebo) and skin toxicity (46 21% vs two 1%), both mostly grade 2. The commonest grade 3–4 toxicities were fatigue (24 11% vs 13 6% patients) and diarrhoea (13 6% vs two 1%). Serious adverse events were reported in 109 (49%) of 224 patients assigned to gefitinib and 101 (45%) of 225 on placebo. 54 (24%) of patients in the gefitinib group achieved disease control at 8 weeks, as did 35 (16%) of patients on placebo (p=0·023). Interpretation The use of gefitinib as a second-line treatment in oesophageal cancer in unselected patients does not improve overall survival, but has palliative benefits in a subgroup of these difficult-to-treat patients with short life expectancy. Future research should focus on identification of predictive biomarkers to identify this subgroup of benefiting patients. Funding Cancer Research UK.
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