Search

Loss to follow-up (LTFU) distorts results of randomized controlled trials (RCTs). Understanding trial characteristics that contribute to LTFU may enable investigators to anticipate the extent of LTFU and plan retention strategies. The objective of this systematic review and meta-analysis was to investigate the extent of LTFU in surgical RCTs and evaluate associations between trial characteristics and LTFU. MEDLINE, Embase, and PubMed Central were searched for surgical RCTs published between January 2002 and December 2021 in the 30 highest impact factor surgical journals. Two-hundred eligible RCTs were randomly selected. The pooled LTFU rate was estimated using random intercept Poisson regression. Associations between trial characteristics and LTFU were assessed using metaregression. The 200 RCTs included 37,914 participants and 1307 LTFU events. The pooled LTFU rate was 3.10 participants per 100 patient-years (95% confidence interval [CI] 1.85-5.17). Trial characteristics associated with reduced LTFU were standard-of-care outcome assessments (rate ratio [RR] 0.17; 95% CI 0.06-0.48), surgery for transplantation (RR 0.08; 95% CI 0.01-0.43), and surgery for cancer (RR 0.10; 95% CI 0.02-0.53). Increased LTFU was associated with patient-reported outcomes (RR 14.21; 95% CI 4.82-41.91) and follow-up duration ≥ three months (odds ratio 10.09; 95% CI 4.79-21.28). LTFU in surgical RCTs is uncommon. Participants may be at increased risk of LTFU in trials with outcomes assessed beyond the standard of care, surgical indications other than cancer or transplant, patient-reported outcomes, and longer follow-up. Investigators should consider the impact of design on LTFU and plan retention strategies accordingly. [ABSTRACT FROM AUTHOR]

• Stressed employees completed a smartphone-based mindfulness program (or control). • Mindfulness led to down-regulation of the NF-KB transcription control pathway. • There was no time by condition difference in self-reported perceived stress. • Mindfulness training may be effective for improving immune cell gene regulation. Mindfulness meditation training has been shown to be an effective stress reduction strategy, but less is known about its immunoregulatory impact. In a randomized controlled trial of stressed customer service workers, the present study tested whether a 30-day smartphone-based mindfulness meditation training program (compared to a problem-solving control program) would affect pro-inflammatory gene expression. Both interventions led to reductions in stress levels, but there was no difference in stress reduction between conditions. Consistent with predictions, mindfulness training reduced activity of the pro-inflammatory NF-κB transcription control pathway compared to the active control. These results suggest that mindfulness training may be a particularly effective method for improving immune cell gene expression in stressful work environments. [ABSTRACT FROM AUTHOR]

There is limited evidence regarding the effectiveness of preventive interventions for anxiety disorders. We aim to test the effectiveness of multiple health behavior change (MHBC) interventions in the reduction of symptoms of anxiety in the adult population. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted by searching the most relevant databases and registry platforms in the area. Reference lists of included articles and relevant systematic reviews and meta-analyses of MHBC interventions that examined anxiety or depression as outcomes were also manually searched. To identify RCTs that evaluated preventive interventions, we excluded studies in which the target population included only patients meeting the diagnostic criteria for anxiety disorders. To pool results, the standardized mean difference (SMD) was calculated using the random effects model. Sensitivity, subgroup and meta-regression analyses were performed. Forty-six RCTs were included in the qualitative synthesis, and 34 RCTs were included in the meta-analysis. Thirty RCTs were focused on promoting healthy diet and physical activity, whereas the other 16 studies also focused on smoking cessation. The pooled SMD was small (−0.183; 95% CI -0.276 to −0.091) but significant (p < 0.001). The effect became non-significant when only studies with a low risk of bias were included. There was substantial and significant heterogeneity between the studies. There is currently insufficient evidence regarding the effectiveness of MHBC interventions to reduce symptoms of anxiety in the adult population. • Extensive search following PRISMA statement, which included 47 RCTs in the SR and 35 RCTs in the MA. • Most of the intervention targeted the promotion of physical activity and healthy diet. • Quality of evidence was low and there was high heterogeneity between studies. • No firm conclusions can be drawn on the effectiveness of MHBC interventions in reducing symptoms of anxiety. [ABSTRACT FROM AUTHOR]

There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the superiority of ICG-99mTc-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma (VSCC) patients compared to standard SLN detection using 99mTc-nanocolloid with blue dye. In this multicenter, randomized controlled trial, VSCC patients underwent either the standard SLN procedure or with the hybrid tracer ICG-99mTc-nanocolloid. The primary endpoint was the percentage of fluorescent SLNs compared to blue SLNs. Secondary endpoints were successful SLN procedures, surgical outcomes and postoperative complications. Forty-eight patients were randomized to the standard (n = 24) or fluorescence imaging group (n = 24) using ICG-99mTc-nanocolloid. The percentage of blue SLNs was 65.3% compared to 92.5% fluorescent SLNs (p < 0.001). A successful SLN procedure was obtained in 92.1% of the groins in the standard group and 97.2% of the groins in the fluorescence imaging group (p = 0.33). Groups did not differ in surgical outcome, although more short-term postoperative complications were documented in the standard group (p = 0.041). Intraoperative visual detection of SLNs in patients with VSCC using ICG-99mTc-nanocolloid was superior compared to 99mTc-nanocolloid and blue dye. The rate of successful SLN procedures between both groups was not significantly different. Fluorescence imaging has potential to be used routinely in the SLN procedure in VSCC patients to facilitate the search by direct visualization. Clinical Trial Registration: Netherlands Trial Register (Trial ID NL7443). [ABSTRACT FROM AUTHOR]

To assess longitudinal effects of a nutrition intervention on fruit and vegetable (F&V) intake among Primary Health Care (PHC) service participants in Belo Horizonte, Brazil. Demographics and health data on 3414 PHC service participants were collected at baseline in 2013–2014. F&V intake was assessed at baseline, 12, 36, and 48 months until 2017–2018. Services were randomized to control (CG, usual care) or intervention (IG, usual care and a Transtheoretical Model-based intervention to increase F&V intake). We performed difference-in-differences (DiD) analysis to identify intervention effects on F&V intake, and sensitivity analyses of participants observed at all timepoints. Participants were mostly middle-aged, low-income women. Mean baseline intakes were 168.7 g of fruit, 202.0 g of vegetables, and 370.7 g of F&V, with lower fruit in the IG (164.1 g) than the CG (172.3 g). At 12 months, the intervention increased fruit intake in the IG and fruit and F&V intake among individuals with low baseline F&V intake. Fruit intake remained higher at 36 months in the IG. No effect on vegetable intake was identified. According to sensitivity analyses, effects on fruit intake among the complete sample did not remain significant at 36 months, and an effect on fruit intake at 36 months was identified among those with adequate baseline F&V intake. Reductions in F&V intake did not remain significant. At 12 months, a TTM-based intervention increased fruit intake in the overall sample, and fruit and F&V intake among individuals with low baseline intakes. Repeated interventions may be needed over time. Trial registration number: RBR-9h7ckx. • Intervention increased fruit intake at 12 months in the complete sample; • Fruit and F&V increased at 12 months among those with low baseline intake; • Vegetable intake was not affected by intervention; • Structural factors might affect intervention effects and hinder maintenance; • Repeated interventions may be needed to increase and sustain F&V intake over time. [ABSTRACT FROM AUTHOR]

Objectives: To assess feasibility/acceptability of a mindfulness-based approach to excess weight prevention in adolescents at-risk for excess weight gain. To pilot test efficacy of a mindfulness-based intervention for improving food reward sensitivity, stress-eating, executive function (EF), and BMI/adiposity.Methods: A pilot randomized controlled trial was conducted with 12-17y adolescents at-risk for excess weight gain based on above-average weight (body mass index [BMI]≥70%ile) or parental history of obesity (BMI≥30 kg/m2). Adolescents were randomized to a mindfulness-based (n = 29) or health education control group (n = 25) that met for six weekly one-hour sessions. Feasibility/acceptability were determined from attendance and acceptability survey ratings. At baseline, six-week and six-month follow-up, adolescents' perceived stress was measured with the Perceived Stress Scale, food reward sensitivity with a behavioral task, stress-eating during a laboratory test meal, and EF with the parent-reported Behavior Rating Inventory of Executive Function and NIH Toolbox. At the same intervals, BMI indices and body fat by air displacement plethysmography were assessed in a fasted state.Results: Median session attendance was 6:6 sessions in both conditions; program acceptability ratings were above-average. Compared to health education, adolescents in mindfulness had lower food reward sensitivity at six-months (Cohen's d = 0.64, p = .01). There were no between-condition differences in BMI (mindfulness vs. health educationΔsix-months 95%CI 0.20, 1.52 kg/m2 vs. 0.21, 1.62 kg/m2) or adiposity (-3.64, -0.61% vs. -4.31, -1.04%) changes.Conclusions: A mindfulness-based group intervention is feasible/acceptable among adolescents at-risk for excess weight. In this pilot sample, mindfulness and health education were equivocal for BMI/adiposity outcomes. Future trials with a larger, adequately-powered sample and longer-term follow-up are necessary to test efficacy of a mindfulness-based intervention for food reward sensitivity, stress-eating, EF, and stabilizing growth trajectories in youth at-risk for adult obesity. [ABSTRACT FROM AUTHOR]

• VNS therapy titration to a target output current of 1.5 mA is achievable in most patients in <3 months. • Use of more tolerable stimulation parameters during titration delays achievement of a therapeutic dose. • VNS therapy is generally well tolerated and associated with improvements in mood. Vagus Nerve Stimulation (VNS) therapy is widely understood to provide clinically meaningful improvements in seizure control to patients with drug-resistant epilepsy, and has been a staple in the clinical armamentaria available to epileptologists for over 25 years. Despite the long history of evidence-based reviews by neurology professional societies, there is still evidence of a practice gap in VNS titration and dosing that aims to maximize clinical benefit. Recent retrospective analyses have strongly argued for a more consistent application of a population-wide target dose of VNS, and further argued the importance of quickly achieving this target dose to hasten the onset of clinical benefits; however, these analyses failed to provide evidence for practical implementation. Herein, we describe a randomized controlled trial assessing the impact of titrating VNS according to three different protocols to achieve the target dose of 1.5 mA at 500µsec, for a 20-Hz signal frequency. The study was registered as NCT02385526 on March 11, 2015. Sixty-two patients were randomized into treatment groups that followed different titration protocols. One protocol (Group A) was designed to align with currently accepted professional guidance for VNS titration and the manufacturer's labeling for VNS in epilepsy (Heck et al., 2002), while the other two protocols were derived from VNS applications in other therapeutic areas. Group A participants were most likely to achieve the target dose parameters in 12 weeks or less (81.8%), with a median time-until-achievement of the target dose of 8.1 weeks, while less than 60% of patients in other groups were able to achieve the same endpoint. Participants in all groups experienced low levels of transient tolerability concerns and adverse events, suggesting titration to the target dose in 12 weeks or less following the Group A protocol is generally acceptable to most patients. These findings indicate that patients receiving VNS for epilepsy can achieve the manufacturer-recommended dose range in 12 weeks or less. A wider implementation of the approach will likely improve the clinical impact of VNS on seizure control and prevent undertreatment. [ABSTRACT FROM AUTHOR]

Tobacco smoking is a major preventable cause of death, and a significant public health problem worldwide. Most smokers begin in adolescence, age at which they are more susceptible to nicotine addiction. The prevalence of smoking in adolescence is considerable. Therefore, it would be convenient to incorporate smoking prevention programs in the school environment. It is necessary to provide evidence of its effectiveness. The primary objective of the study was to evaluate the effectiveness of a teacher-delivered school-based intervention on the initiation of smoking in adolescents (ITACA smoking prevention education program). A multi-center cluster randomized trial was designed. Twenty-two secondary schools from Spain were enrolled in 2 successive cohorts, from 2010 to 2011. The intervention consisted in the application of the ITACA smoking prevention education program. A 4-year cognitive-behavioral intervention that is based on the social-influences model and is integrated into schools' regular curricular activities. A total of 1055 students were surveyed before the intervention (age: 12-13 years-old), and at the third year of the intervention (age: 14-15 years-old) of a 4-year education program. The outcome measures were daily and weekly use of cigarettes, and initiation of smoking. There was no evidence that the intervention impacted the incidence of regular smoking (OR = 1.08; 95% CI: 0.50-2.33) or the initiation of smoking (OR = 1.09; 95% CI: 0.56-1.72). This trial provides evidence supporting the non-effectiveness of a complex educational smoking prevention program at 3 years after the intervention.Trial Registration Number: Current Controlled Trials: NCT01602796. [ABSTRACT FROM AUTHOR]

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC.Trial Registration: ClinicalTrials.gov, NCT01134029. [ABSTRACT FROM AUTHOR]

Background Recent studies have highlighted the risk of bias and the fragility of results in randomized controlled trials (RCTs). The aim of our study was to evaluate the clinical practice guidelines created by the Society for Gastrointestinal and Endoscopic Surgeons (SAGES) for fragility, statistical power, and risk of bias. Materials and methods We screened the SAGES clinical practice guideline references for qualifying RCTs. RCTs were assessed for risk of bias using the Cochrane Collaboration Risk of Bias tool 2.0. We used the fragility index and fragility quotient to evaluate the robustness of trial results and conducted a power analysis using G*Power to determine if trials were adequately powered. Results Twenty-two (40.7%) of the 54 trials that we assessed were rated as having a high risk of bias, 17 (31.5%) were rated as having a low risk of bias, and 15 (27.8%) were rated as having some concerns. The median fragility index was 2.5 (interquartile range 1-7). The median fragility quotient was 0.021 (interquartile range 0.003-0.045). Mean sample size was 108, and the mean loss to follow-up was eight patients. Eight of 33 trials (24.2%) were found to be underpowered according to the sample size used in the primary outcome. Conclusions Guidelines created by SAGES are supported by RCTs that are frequently fragile or underpowered or have a high risk of bias. Future RCTs should utilize the Consolidated Standards of Reporting Trials statement, implement strategies to minimize loss to follow-up, and use properly powered sample sizes. [ABSTRACT FROM AUTHOR]

Our aim was to explore the putative beneficial effects of low-to-moderate intensity exercise training program in patients with irritable bowel syndrome (IBS). This study evaluated the changes in blood oxidative stress status, inflammatory biomarkers and IBS severity symptoms following 24 weeks of moderate aerobic exercise in sedentary IBS patients. A total of 109 female volunteers (aged 18–41 yrs) who fulfilled Rome III criteria for the diagnosis of IBS were screened and 60 were randomized to exercise (EX, n = 30) and non-exercise (NON-EX, n = 30) groups. Exercise intervention favorably attenuated inflammation as indicated by plasma cytokines (IL-1β, IL-6, IL-8, IL-10 and TNF-α), adenosine deaminase, oxidative stress (XO, MDA and NO) and enhanced antioxidants (SOD, CAT and GSH-Px) (P < .05), and these alterations correlate with promising improvements in IBS symptoms (P < .05). Taken together, low-to-moderate intensity exercise training program attenuates symptoms in IBS. Symptom improvement was associated with a reversal of the ratio of anti- to pro-inflammatory cytokines as well as facilitating blood redox homeostasis, suggesting an immune- and redox modulating function for exercise training. [ABSTRACT FROM AUTHOR]

The promotion of students’ achievement and competence in the so-called STEM disciplines is one cornerstone of current educational research and practice. In particular, as early as elementary school, the fostering of an adequate understanding of science is a normative goal of science education. It facilitates students’ science learning and enables them to understand the nature and development of scientific knowledge. Based on the relevance of the promotion of young children’s understanding of science, a corresponding science intervention was recently developed and successfully evaluated in a first study under highly controlled conditions. The goal of the present study was to investigate the effectiveness of this intervention when implemented in practice. One hundred seventeen third- and fourth-grade students and 10 trained course instructors participated in this study. We applied a randomized block design with waitlist control groups and repeated measures. The results revealed that children assigned to the intervention compared with children assigned to the waitlist control group showed better inquiry-related methodological competencies (a better understanding of the scientific inquiry cycle and experimentation strategies) and a higher need for cognition. The findings point to the successful implementation of the intervention and are compared with the results of the first study. [ABSTRACT FROM AUTHOR]

This study investigated for the first time the changes in seminal markers of inflammation, oxidative stress status, semen parameters, sperm DNA integrity as well as pregnancy rate following 24 weeks of moderate aerobic exercise in infertile patients. A total of 1026 sedentary men (aged 25–40 years) attending the infertility clinic with history of more than one year of infertility, were screened and 419 were randomized to either exercise (EX, n = 210) or non-exercise (NON-EX, n = 209) groups. Exercise training favorably attenuated seminal markers of both inflammation (IL-1β, IL-6, IL-8, and TNF-α) and oxidative stress (ROS, MDA, 8-Isoprostane) as well as enhanced antioxidant defense system (SOD, catalase and TAC) (P < 0.05). These changes correlate with favorable improvements in semen parameters, sperm DNA integrity and pregnancy rate (P < 0.05). The results provide information about the effectiveness of moderate aerobic exercise training as a treatment option for male factor infertility. The 4-week detraining period was not enough to reverse all benefits promoted by exercise intervention. [ABSTRACT FROM AUTHOR]

Background Nebulized magnesium sulfate (MgSO 4 ) has been used to treat asthma, but the efficacy remains controversial. We aimed to comprehensively review the efficacy of nebulized MgSO 4 in treating adult patients with asthma. Methods PubMed, Embase, and Cochrane Library were searched for relevant studies published up to July 18, 2016. Randomized controlled trials (RCTs) were included if adult patients with acute or stable asthma had been treated with nebulized MgSO 4 compared with placebo or another bronchodilator. Standardized mean differences (SMDs), relative risks (RRs) and 95% confidence intervals (CIs) were calculated. Outcomes included pulmonary function, hospital admission and adverse events. Results A total of 1386 patients from sixteen trials (1240 acute asthma patients and 146 stable asthma patients) were subjected to meta-analysis. Compared to placebo as normal saline, whether using in acute or stable adult asthma, nebulized MgSO 4 did not significantly improve the respiratory function: SMD 0.39 (95% CI −0.03–0.82, P = 0.07), and 1.48 (95% CI −0.14–3.11, P = 0.07), respectively. Furthermore, nebulized MgSO 4 did not reduce hospital admission in adult patients with acute asthma (RR, 0.72; 95% CI, 0.52–1.00; P = 0.05), although it was not associated with increased adverse events (RR 1.15; 95% CI, 0.88–1.52; P = 0.31). Conclusions Evidence to date suggests that nebulized MgSO 4 has no role in the management of adult patients with acute or stable asthma. [ABSTRACT FROM AUTHOR]

The prevalence of cigarette smoking in young adults is higher among those with socioeconomic disadvantage than those without. Low treatment-seeking among young adult smokers is compounded by few efficacious smoking cessation interventions for this group, particularly socioeconomically-disadvantaged young adults (SDYA) who smoke cigarettes. The goal of this study was to test a tailored smoking-cessation intervention for SDYA. 343 SDYA aged 18-30 living in the U.S. (85% female) who smoke cigarettes with access to a smartphone and interest in quitting smoking in the next six months were recruited online in Spring 2020 and randomized to referral to online quit resources (usual care control; n = 171) or a 12-week tailored text message smoking-cessation program with a companion web-based intervention (n = 172). Intent to treat analyses examined associations between study condition, self-reported 30-day point prevalence abstinence (PPA), and confidence to quit smoking at 12 weeks, controlling for potential confounders. Intervention group participants had greater self-reported 30-day PPA at 12-weeks than controls (adjusted relative risk 3.93, 95% CI 2.14-7.24). Among those who continued smoking, the intervention increased confidence to quit (0.81 points, 95% confidence interval 0.08-1.53). Weekly engagement in the intervention predicted greater cessation. A tailored text message intervention for SDYA increased smoking abstinence and confidence to quit at the end-of-treatment. Findings may have been influenced by recruitment at the start of the COVID pandemic but suggest that text messaging is an acceptable and efficacious cessation strategy for SDYA smokers. Future studies should examine the impact on longer-term smoking-cessation and importance of intervention tailoring for SDYA. [ABSTRACT FROM AUTHOR]

Meditation training may promote pro-environmental behavior and related variables, though limited research has tested this experimentally. We investigated whether short- or long-term meditation training were associated with pro-environmental behavior, environmental attitudes, and sustainable well-being (i.e., well-being per unit consumption). In a cross-sectional comparison, long-term meditators (n = 31; mean = 9154 meditation hours) displayed greater environmental attitudes (d = 0.63) but not pro-environmental behavior or sustainable well-being compared to meditation-naïve participants (d s = -0.14–0.27). In a randomized controlled trial (n = 125), eight-week training in Mindfulness-Based Stress Reduction did not significantly improve target variables relative to waitlist or structurally-matched active control (d s = −0.38–0.43). However, relative to waitlist, randomization to either meditation or active control predicted increases in pro-environmental behavior (d = −0.40) and sustainable well-being (d = 0.42), although the latter finding was not robust to multiple imputation. While meditation training may promote pro-environmental behavior and its antecedents, the training investigated here does not appear to be uniquely effective. • Long-term meditation training may increase environmental attitudes. • Long-term meditation training is not associated with pro-environmental behavior. • Short-term mindfulness training does not improve sustainability-related variables. • Active interventions may increase pro-environmental behavior relative to waitlist. [ABSTRACT FROM AUTHOR]

Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects. [ABSTRACT FROM AUTHOR]

Background Tumor necrosis factor-α (TNF-α) is a key inflammatory mediator and its reduction is a therapeutic target in several inflammatory diseases. Curcumin, a bioactive polyphenol from turmeric, has been shown in several preclinical studies to block TNF-α effectively. However, clinical evidence has not been fully conclusive. Objective The aim of the present meta-analysis was to evaluate the efficacy of curcumin supplementation on circulating levels of TNF-α in randomized controlled trials (RCTs). Methods The search included PubMed-Medline, Scopus, Web of Science and Google Scholar databases by up to September 21, 2015, to identify RCTs investigating the impact of curcumin on circulating TNF-α concentration. Quantitative data synthesis was performed using a random-effects model, with weighed mean difference (WMD) and 95% confidence interval (CI) as summary statistics. Meta-regression and leave-one-out sensitivity analyses were performed to assess the modifiers of treatment response. Results Eight RCTs comprising nine treatment arms were finally selected for the meta-analysis. There was a significant reduction of circulating TNF-α concentrations following curcumin supplementation (WMD: −4.69 pg/mL, 95% CI: −7.10, −2.28, p < 0.001). This effect size was robust in sensitivity analysis. Meta-regression did not suggest any significant association between the circulating TNF-α-lowering effects of curcumin with either dose or duration (slope: 0.197; 95% CI: −1.73, 2.12; p = 0.841) of treatment. Conclusion This meta-analysis of RCTs suggested a significant effect of curcumin in lowering circulating TNF-α concentration. [ABSTRACT FROM AUTHOR]

Background: School-based trials to prevent and reduce prevalence of pediatric obesity in low-income countries are necessary. In Brazil, addressing adolescent obesity is a public health priority.Objective: To evaluate the impact of a group randomized controlled trial involving a 6-month multicomponent school-based obesity prevention program targeting adolescent girls.Methods: The Healthy Habits, Healthy Girls-Brazil program recruited participants (n=253; 16.05±0.05 years) from ten eligible public technical schools in São Paulo, Brazil. The program was adapted from an Australian intervention study, which is based on the Social Cognitive Theory. The primary outcome measure was body mass index (BMI), and secondary outcomes included BMI z score, waist circumference, and various sedentary and dietary health-related behaviours.Results: Although changes in BMI were not statistically significant, differences favored the intervention group (adjusted mean difference, -0.26kg/m(2),se SE=0.018, p=0.076). Statistically significant intervention effects were found for waist circumference (-2.28cm; p=, p=0.01), computer screen time on the weekends (0.63h/day, p; p=0.02), total sedentary activities on the weekends (-0.92h/day, p<0.01), and vegetable intake (1.16servings/day, p=0.01).Conclusion: These findings provide some evidence for the benefit of a school-based intervention to prevent unhealthy weight gain in adolescent girls living in low-income communities. [ABSTRACT FROM AUTHOR]

This study aimed to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) in order to calculate the effect size of statin therapy in changing plasma cortisol concentrations. Following a systematic search in Medline, SCOPUS, Web of Science and Google Scholar databases (by up to March 01, 2015), 7 eligible RCTs were selected. Random-effects meta-analysis suggested a significant increase in plasma cortisol concentrations following statin therapy (WMD: 6.34%, 95% CI: 1.80, 10.87, p = 0.006). Subgroup analysis confirmed the significance of the effect with lipophilic statins comprising atorvastatin, simvastatin, and lovastatin (WMD: 7.00%, 95% CI: 2.21, 11.79, p = 0.004) but not with hydrophilic statins (rosuvastatin and pravastatin) (WMD: 0.60%, 95% CI: −13.46, 14.66, p = 0.933). In the meta-regression analysis, changes in plasma cortisol concentrations following statin therapy were found to be independent of treatment duration. Results of this meta-analysis of RCTs suggest a significant elevation in plasma cortisol levels following statin therapy. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neo-adjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. Methods We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days. Results At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups. Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127–2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012–1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014–1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948–1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p = 0.014; RR = 1.208; CI = 1.046–1.395), that were less frequent in Group A (13%) than in Group B (28%). Conclusions Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen. [ABSTRACT FROM AUTHOR]

Previous meta-analyses of pulmonary arterial hypertension (PAH) combination therapy pooled sequential and initial combination together, which might threaten their authenticity and clinical significance for the difference between two strategies. PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs) that compared sequential combination therapy (SCT) with background therapy (BT) in PAH patients. Raw data were extracted to calculate risk ratio (RR) or weighted mean difference (WMD) for predefined efficacy and safety outcomes. Mantel-Haenszel fixed or random effects model was used based on heterogeneity. 17 RCTs involving 4343 patients (97.2% of patients with WHO-FC II-III) were included. SCT decreased clinical worsening (RR 0.66, 95% CI 0.58 to 0.76), nonfatal clinical worsening (RR 0.61, 95% CI 0.52 to 0.71), functional class (decrease of 28% in the portion of patients with WHO-FC worsening and increase of 33% in the portion of patients with WHO-FC improvement), and increased 6-min walk distance (WMD 17.68 m, 95% CI 10.16 to 25.20), but didn't reduce mortality, lung transplantation, admission to hospital, and treatment escalation compared with BT. Although any adverse event and serious adverse event were similar between SCT and BT, SCT increased all-cause treatment discontinuation (RR 1.49, 95% CI 1.30 to 1.71) and drug-related treatment discontinuation (RR 2.30, 95% CI 1.86 to 2.84) with higher incidence of headache, flushing, nausea, diarrhoea and jaw pain. For WHO-FC II-III PAH patients who have established BT, our study reinforced the recommendation of SCT to improve clinical worsening, functional status, and exercise capacity, although with higher incidence of side-effects and withdrawal. [ABSTRACT FROM AUTHOR]

Objective We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. Method Secondary analysis of a randomized controlled trial: In 2002-2004, 8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6 months during the 3-year follow-up. Results In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 15.3% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group × time: = 0.005). The effect was largest after 6 and 12 months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24 months. Conclusion A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. Trial Registration: ClinicalTrials.gov (www.clinicaltrials.gov): NCT00379249. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of this study is to assess the effectiveness of a very brief structured counseling for tobacco cessation in dentistry clinics. METHOD: A cluster randomized trial was conducted in Sweden in 2012-2013. Twenty-seven dentistry clinics in two Swedish counties were randomized to provide either a structured brief advice based on the 5 A's model or usual care. Participants were 467 patients currently using tobacco daily (225 in the intervention group and 242 in usual care), of which 97% were retained at follow-up, six months after enrolment. Study outcomes were: 7-day abstinence (primary outcome); 3-month sustained abstinence; 50% reduction of the amount tobacco used; quit attempts lasting at least 24h. RESULTS: Compared to usual care, brief counseling was not associated to statistically significant increase in the proportion abstinent from tobacco use after 6months. However, there was a statistically significant association with reduction of tobacco consumption (OR=2.07 95% CI 1.28-3.35). Changes in the expected direction for all outcomes were more frequent in the intervention than in the usual care group, and larger among exclusive snus users than among smokers. CONCLUSIONS: Very brief and structured counseling in dentistry may achieve positive behavioral modifications among tobacco users, with significant reduction of tobacco consumption, particularly among smokeless tobacco users. [ABSTRACT FROM AUTHOR]

One of the largest disparities in cancer mortality in the United States occurs with colorectal cancer (CRC). The objectives of this multilevel two-arm intervention trial were to compare the efficacy of two interventions to promote CRC screening (CRCS) with fecal immunochemical test (FIT) and examine sociodemographic and psychosocial predictors of FIT screening. Individuals ages 50-75 (n = 326) who were not up-to-date with CRCS, could understand English or Spanish, and were at average CRC risk were recruited from two federally qualified health centers (FQHCs) in Florida. Prior to intervention, CRCS rates in the FQHCs were 27.1% and 32.9%, respectively. Study enrollment occurred April 2018-November 2019. System-level intervention components included leveraging electronic medical record (EMR) systems and delivering patient reminders. Participants were randomized to C-CARES (education+FIT) or C-CARES Plus (C-CARES+personalized coaching [for those not completing FIT within 90 days]). Primary outcome was completed FIT returned <1 year. Primary outcome analyses were performed using logistic regression. 225 participants completed FIT (69.0% [95% CI: 64.0-74.0%]), with no significant difference in FIT uptake by intervention arm (67.3% C-CARES Plus vs. 70.8% C-CARES; p = .49). FIT uptake was significantly higher among patients who received intervention materials in Spanish (77.2%) compared to those who received materials in English (63.2%, p < .01). The personalized coaching in the C-CARES Plus arm did not appear to provide added benefit beyond the C-CARES intervention. Multilevel approaches that include EMR prompts, reminders, FIT access, and provision of low-literacy, language-concordant education can support efforts to improved community clinics' CRCS rates. Future efforts should focus on repeat FIT screening. Trial registration: The trial was registered at ClinicalTrials.gov (NCT03906110). [ABSTRACT FROM AUTHOR]

Objective Afterschool programs can be health-promoting environments for children. Written policies positively influence nutrition and physical activity (PA) environments, but effective strategies for building staff capacity to write such policies have not been evaluated. This study measures the comprehensiveness of written nutrition, PA, and screen time policies in afterschool programs and assesses impact of the Out of School Nutrition and Physical Activity (OSNAP) intervention on key policies. Methods Twenty afterschool programs in Boston, MA participated in a group-randomized, controlled trial from September 2010 to June 2011. Intervention program staff attended learning collaboratives focused on practice and policy change. The Out-of-School Time (OST) Policy Assessment Index evaluated written policies. Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed. Results The measure demonstrated moderate to excellent inter-rater reliability (Spearman's r=0.53 to 0.97) and construct validity. OSNAP was associated with significant increases in standards-based policy statements surrounding snacks (+ 2.6, p=0.003), beverages (+ 2.3, p=0.008), screen time (+ 0.8, p=0.046), family communication (+ 2.2, p=0.002), and a summary index of OSNAP goals (+ 3.3, p=0.02). Conclusions OSNAP demonstrated success in building staff capacity to write health-promoting policy statements. Future research should focus on determining policy change impact on practices. [ABSTRACT FROM AUTHOR]

Highlights: [•] RCT on the effects of a mean 12% price increase on sugar sweetened beverages (SSBs) [•] 102 participants purchased groceries on a single occasion at a Virtual Supermarket [•] The 12% price increase significantly decreased SSB purchases by .9 L/household/week [•] The 12% price increase on SSB had no effects on purchases in other categories [ABSTRACT FROM AUTHOR]

Abstract: Objective: To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. Method: We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007–2010. Data collectors, but not facilitators or participants, were blind to group assignment. Results: Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09–1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. Conclusion: A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. Trial registration: ClinicalTrials.gov Identifier: NCT01490359. [Copyright &y& Elsevier]

Abstract: Objective: To study whether demographic and smoking-related characteristics are associated with participation (reach) in a smoking cessation trial and subsequent use (uptake) of two specific smoking interventions (Internet-based program and proactive telephone counseling). Methods: We used data from a four-arm randomized smoking cessation trial (2011). Participants (n =1,809) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark (2007–2008 and 2010). Interventions were as follows: (1) an Internet-based smoking cessation program, (2) proactive telephone counseling, (3) reactive telephone counseling and (4) a self-help booklet. Results: Reach (defined as the proportion accepting to participate in the trial of those invited) was highest among persons aged 40–59years, women, heavy smokers and persons with long education. Among trial participants, uptake (defined as any use of the specific intervention at 1-month follow-up) was 69% for the Internet-based program, 74% and 9% for proactive and reactive telephone counseling, respectively, and 84% for the self-help booklet. Young age was associated with the uptake of the Internet-based program, and short education was associated with using proactive telephone counseling. Conclusions: Internet-based interventions and proactive telephone counseling appeal to different age and educational groups. Further, offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake. [Copyright &y& Elsevier]

Abstract: Objective: To assess the impact of a web-based intervention supplemented with text messages to reduce cancer risk linked with smoking, unhealthy diet, alcohol consumption, obesity, sedentary lifestyle and sun exposure. Methods: A total of 2001 voluntary adolescents from Spain and Mexico were recruited between 2009 and 2012 and randomly assigned to: one control group and two experimental groups, which received exclusively the online intervention (experimental group 1) or the intervention supplemented with encouraging text messages (experimental group 2). The educational intervention was based on both: successful psychosocial models (i.e. A.S.E. and Transtheoretical model) and the school curriculum. Results: After a 9-month follow-up, the prevalence of students who did not eat fruit was reduced significantly in all groups: experimental group 1 (−62.6%), experimental group 2 (−71.5%) and even the control group (−66.8%). Being overweight was only reduced in the experimental group 2 (−19.6%). The total cancer behavioral risk score, which ranged from 0 to 100 points (highest risk), was significantly reduced in the experimental group 1 (−3.5 points) and in the experimental group 2 (−5.3 points). The text-supplemented online intervention increased the probability of improving the post-test total cancer behavioral risk (OR=1.62). Conclusion: The web-based intervention supplemented with text messages had a positive global impact, but it lead to only minimal changes in risky behaviors. This intervention appears useful in controlling overweight adolescents. Clinical trial registration number: ISRCTN27988779. [Copyright &y& Elsevier]

Abstract: Objective: This report describes findings from a randomized controlled trial of an intervention to increase colorectal cancer (CRC) screening in primary care practices in Appalachian Kentucky. Methods: Sixty-six primary care practices were randomized to early or delayed intervention groups. The intervention was provided at practices using academic detailing, a method of education where providers receive information on a specific topic through personal contact. Data were collected in cross-sectional surveys of medical records at baseline and six months post-intervention. Results: A total of 3844 medical records were reviewed at baseline and 3751 at the six-month follow-up. At baselines, colonoscopy was recommended more frequently (43.4%) than any other screening modality, followed by fecal occult blood testing (18.0%), flexible sigmoidoscopy (0.4%), and double-contrast barium enema (0.3%). Rates of documented screening results were higher for all practices at the six-month follow-up for colonoscopy (31.8% vs 29.6%) and fecal occult blood testing (12.2% vs 11.2%). For early intervention practices that recommended screening, colonoscopy rates increased by 15.7% at six months compared to an increase of 2.4% in the delayed intervention practices (p=.01). Conclusions: Using academic detailing to reach rural primary care providers with a CRC screening intervention was associated with an increase in colonoscopy. [Copyright &y& Elsevier]

Abstract: Objective: The objective was to test the effectiveness of a mail campaign that included blood pressure (BP) measurements from patients treated by emergency medical technicians (EMTs) to motivate them to (re)check their BP at a fire station. The mailing used a 2×2 research design tailoring on risk and source personalization. Method: In this randomized controlled trial, participants were randomized into a control group or one of four experimental groups. Participants residing in one of four fire departments in a Pacific Northwest metropolitan area were eligible if they had a systolic BP≥160mm Hg and/or diastolic BP≥100mm Hg when seen by EMTs during the study period (July 2007–September 2009). Results: Of 7106 eligible participants, 40.7% were reached for a follow-up interview. Multivariable logistic regression analysis showed that although the absolute number of fire station BP checks was low (4%), participants who received any mailed intervention had a 3 to 5-fold increase in the odds of reporting a fire station BP check over controls. Fire station visits did not differ by type of tailored mailing. Conclusion: Partnering with Emergency Medical Services is an innovative way to identify high-risk community members for population health interventions. [Copyright &y& Elsevier]

• Pharmaceutical care helps to improve the management of depression in epilepsy. • Depression has an inverse relationship with quality of life in epilepsy. • The pharmacist should be included in the epilepsy health team. Depression is the most frequent comorbidity of epilepsy, and they are both complex chronic diseases that affect health-related quality of life (HRQOL), especially in women. Pharmaceutical care may contribute significantly to the improvement of HRQOL in women with epilepsy (WWE), with the involvement of the pharmacist in the healthcare team treatments could be optimized and negative outcomes related to medication reduced. This was a randomized controlled trial involving WWE over 18 years of age. The intervention group (IG) received a Pharmaceutical care program consisting of medication review follow-up according to Dáder's method, health education, aids for adherence to treatment, registration of seizures and possible triggers, and therapeutic drug monitoring of anticonvulsants. The control group (CG) received the usual care in the institution. The impact in depression was assessed by changes in the Center for Epidemiologic Studies Depression (CES-D) scale, which was applied both at the first and the last interviews, six months later. One hundred eighty-two WWE entered the study and 144 (79.1%) completed it. At the beginning of the study, 48.95% showed signs of depression, decreasing to 30.43% for the patients in the IG (p -value = 0.0238), while for the patients in the CG it remained at 47.30% (p -value = 0.8693). The Wilcoxon test for comparing the change (Δ) (before-after) in the CES-D scores, between groups, yielded a w = 3138.5, p -value = 0.01802 proving there were statistically significant differences. The study proved that the application of a Pharmaceutical Care program significantly decreases signs of depression in WWE. These results allow us to recommend the implementation of the Pharmaceutical care programs to improve the depression in WWE. Trial registration: Current Controlled Trials ISRCTN46864306 IPHIWWE study. [ABSTRACT FROM AUTHOR]

Various melatonin supplementations have been developed to improve health outcomes in various clinical conditions. Thus, we sought to evaluate and summarize the effect of melatonin treatments in clinical settings for health outcomes. We searched PubMed/Medline, Embase, and Cochrane Library from inception to 4 February 2021. We included meta-analyses of randomized controlled trials investigating the melatonin intervention for any health outcome. Based on the different effect sizes of each meta-analysis, we calculated random models' standardized mean differences or risk ratios. We observed robust evidence supported by statistical significance with non-considerable heterogeneity between studies for sleep-related problems, cancer, surgical patients, and pregnant women. Patients with sleep disorder, sleep onset latency (SMD 0.33, 95% CI: 0.10 – 0.56, P < 0.01) were significantly improved whereas no clear evidence was shown with sleep efficiency (1.10, 95% CI: −0.26 to 2.45). The first analgesic requirement time (SMD 5.81, 95% CI: 2.57–9.05, P < 0.001) of surgical patients was distinctly improved. Female patients under artificial reproductive technologies had significant increase in the top-quality embryos (SMD 0.53, 95% CI: 0.27 – 0.79, P < 0.001), but no statistically clear evidence was found in the live birth rate (SMD 1.20, 95% CI: 0.83 – 1.72). Survival at one year (RR 1.90, 95% CI: 1.28 – 2.83, P < 0.005) significantly increased with cancer patients. Research on melatonin interventions to treat clinical symptoms and sleep problems among diverse health conditions was identified and provided considerable evidence. Future well-designed randomized clinical trials of high quality and subgroup quantitative analyses are essential. [Display omitted] • Melatonin in Alzheimer improved the Instrumental Activities of Daily Living. • Pregnancy rates on women with ART shown improvement with melatonin intervention. • Perioperative patients' need for analgesics significantly reduced. • Side effects of radiochemotherapy of cancer improved with melatonin. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To determine whether telephone-based smoking cessation follow-up counseling (FC), when delivered as part of a multi-component intervention program is associated with increased rates of follow-up support and smoking abstinence. Methods: A cluster randomized controlled-trial was conducted within family medicine practices in Ontario, Canada. Consecutive adult patients who smoked were enrolled at two time points, the baseline period (2009) and the post-intervention period (2009–2011). Smoking abstinence was determined by telephone interview 4months following enrollment. Both groups implemented a multi-component intervention program. Practices randomized to the FC group could also refer patients to a follow-up support program which involved 5 telephone contacts over a 2-month period. Results: Eight practices, 130 providers, and 928 eligible patients participated in the study. No statistically significant difference in 7-day point-prevalence abstinence was observed between intervention groups. There was a significant increase in referral to follow-up in both intervention groups. Significantly higher rates of smoking abstinence [25.7% vs. 11.3%; adjusted OR 3.1 (95% CI: 1.1, 8.6), p<0.05] were documented among the twenty-nine percent of FC participants who were referred to the follow-up support program compared to the MC group. Conclusion: Access to external follow-up support did not increase rates at which follow-up support was delivered. [Copyright &y& Elsevier]

Abstract: The study examined whether a dietary planning intervention would help increase fruit consumption among Iranian women focusing on self-regulatory mechanisms in behavior change. We conducted a randomized controlled trial to compare a planning intervention with a control condition in 165 Iranian women (aged 17–48years). Dependent variable was fruit intake, and dietary planning served as the mediator. After baseline assessment (T1) the intervention group received a leaflet on fruit consumption with a planning sheet. Changes were assessed at 3-weeks (T2) and at 3-months follow-ups (T3). Findings showed that the dietary planning intervention led to an increase in fruit intake. Age moderated this mediation. Changes in dietary planning mediated between intervention and fruit consumption in middle aged women. Dietary planning seems to play a role in the mechanism that facilitates fruit intake among Iranian women. This mediation by planning was found in middle aged women (30–48years old), but not in young adult women (17–29years old). [Copyright &y& Elsevier]

Abstract: Objective: This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C. Method: From 2007 to 2010, 255 outpatients with LDL-C>76mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11months. Results: Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference=2.3mg/dL, 95% CI=−3.6, 8.3, p=0.44), nor did the odds of meeting goal LDL-C (OR=0.95, 95% CI=0.6, 1.7; p=0.87). Intakes of calories (p=0.03), total fat (p=0.02), and saturated fat (p=0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p=0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR=1.2, 95% CI=1.0, 1.5, p=0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups. Conclusion: This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors. [Copyright &y& Elsevier]

Abstract: Objective: Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3years). Method: This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005–June 2008). Women aged 40–64 and overdue for screening were recruited from churches and individually randomized to treatment (n =176) or wait-list control (n =169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. Results: Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95% CI: 1.03–6.38, p =0.04. Independent of group, recently screened participants (last Pap >1 but <5years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5years ago), OR=2.50, 95% CI: 1.48–4.25, p =0.001. Conclusions: The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women. [Copyright &y& Elsevier]

Abstract: Objective: Fiscal policies may form a solution in improving dietary intake. This study aimed to examine the effectiveness of varying taxing and subsiding schemes to stimulate healthier food purchases. Methods: A randomized controlled trial with three levels of price reduction on healthy foods (no; 25%; 50%)×three levels of price increase on unhealthy foods (5%; 10%; 25%) factorial design was used. 150 participants were randomized into one of nine conditions and were asked to purchase groceries at a web-based supermarket. Data were collected in the Netherlands in January–February 2010 and analyzed using analysis of covariance. Results: Subjects receiving 50% discount purchased significantly more healthy foods than subjects receiving no (mean difference=6.62 items, p<0.01) or 25% discount (mean difference=4.87 items, p<0.05). Moreover, these subjects purchased more vegetables (mean difference=821g;p<0.05 compared to no discount). However, participants with the highest discount also purchased significantly more calories. No significant effects of the price increases on unhealthy foods were found. Conclusion: Price decreases are effective in stimulating healthy food purchases, but the proportion of healthy foods remains unaffected. Price increases up to 25% on unhealthier products do not significantly affect food purchases. Future studies are important to validate these results in real supermarkets and across different countries. [Copyright &y& Elsevier]

Objective: We implemented a theory-based randomized controlled trial (Living Free of Tobacco, Plus (LIFT+) in ten rural middle schools and assessed impact on tobacco use and fruit/vegetable (F/V) intake in 2008–2010. Data on F/V intake at baseline, immediate post intervention, and 1-year follow-up are presented. Methods: Schools were randomized to intervention or control groups. Goal setting, peer leaders, and class workshops with parent involvement, were intervention features; community partners were supportive. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. Adjusted models comparing intervention and control conditions were analyzed. Results: Sample (n=1119) was 48.5% female, 50% White, with a mean age of 12.7years. Mean F/V servings were significantly higher in intervention schools at immediate post (3.19 servings) and at 1-year (3.02 servings) compared to controls (2.90, 2.69 respectively). Knowledge of 5-a-day recommendation was significantly higher in intervention schools at immediate post test (75.0%) versus controls (53.8%) but not at 1-year follow-up. Conclusions: Intervention schools reported significantly higher mean F/V servings at post intervention and 1-year, and for knowledge of F/V recommendations at immediate post compared to controls. Higher levels of parent and community involvement may further increase F/V intake in future interventions. ClinicalTrials.gov Identifier: NCT01412697. [Copyright &y& Elsevier]

Objectives: To examine if receiving a pedometer along with an intervention toolkit is associated with increased physical activity, aerobic fitness and better self-rated health among individuals with low levels of physical activity or fitness. Methods: The intervention was nested in the Danish Health Examination Survey (DANHES) and carried out in 2008. Participants were randomly assigned to either a pedometer group (n = 326) or a control group (n = 329). Physical activity, aerobic fitness, and self-rated health were measured at baseline and at 3-month follow-up, and differences were tested by Wilcoxons signed rank tests and Chi-squared tests. Results: At follow-up, no significant differences in physical activity, aerobic fitness and self-rated health were found between the groups. However, the oldest participants in the pedometer group reported significantly more walking time compared to the controls (controls = 368min/week, pedometer group = 680min/week, P = 0.05). Among participants who completed the intervention, a significant effect on total walking time was observed (median difference = 225min/week, P = 0.04). Conclusions: The results suggest that receiving a pedometer and along with an intervention toolkit can increase walking time in older individuals, but not in younger individuals. Thus, this type of intervention offers great potential for promoting physical activity in older individuals. Trial registration number: NCT01071811 [Copyright &y& Elsevier]

Abstract: To what extent do the results of randomized controlled trials inform our predictions about the effectiveness of potential policy interventions? This crucial question is often overlooked in discussions about evidence-based policy. The view I defend is that the arguments that lead from the claim that a program works somewhere to a prediction about the effectiveness of this program as it will be implemented here rests on many premises, most of which cannot be justified by the results of randomized controlled trials. Randomized controlled trials only provide indirect evidence for effectiveness, and we need much more than just randomized- controlled-trial results to make reliable predictions. [Copyright &y& Elsevier]

Abstract: Depression is associated with higher rates of suicide and lower quality of life in individuals with epilepsy. We previously published the 12-month outcome from our randomized clinical trial of PEARLS (Ciechanowski P, Chaytor N, Miller J, et al. Epilepsy Behav. Epub 5 July 2010). The purpose of this study was to determine the long-term effectiveness of PEARLS, a home-based collaborative care intervention consisting of problem-solving treatment, behavioral activation, and psychiatric consultation, in individuals with epilepsy. Patients were randomly assigned to PEARLS (N =40) or usual care (N =40), and assessed at baseline and 6, 12, and 18months. Patients assigned to PEARLS achieved lower depression severity (P <0.05) (Hopkins Symptoms Checklist-20), lower suicidal ideation (P <0.02), and better emotional well being (QOLIE-31) (P <0.02) over 18months, compared with patients given the usual care. The PEARLS program significantly reduces depressive symptoms in adults with epilepsy, and this effect is maintained for 18months after baseline and for more than 1year after completion of home visits. [Copyright &y& Elsevier]

Background: Surgical site infection (SSI) after ventral incisional hernia repair (VIH) can result in serious consequences. We sought to identify patient, procedure, and/or hernia characteristics that are associated with SSI in VIH. Methods: Between 2004 and 2006, patients were randomized in four Veteran Affairs (VA) hospitals to undergo laparoscopic or open VIH. Patients who developed SSI within eight weeks postoperatively were compared to those who did not. A bivariate analysis for each factor and a multiple logistic regression analysis were performed to determine factors associated with SSI. The variables studied included patient characteristics and co-morbidities (e.g., age, gender, race, ethnicity, body mass index, ASA classification, diabetes, steroid use), hernia characteristics (e.g., size, duration, number of previous incisions), procedure characteristics (e.g., open versus laparoscopic, blood loss, use of postoperative drains, operating room temperature) and surgeons'' experience (resident training level, number of open VIH previously performed by the attending surgeon). Antibiotic prophylaxis, anticoagulation protocols, preparation of the skin, draping of the wound, body temperature control, and closure of the surgical site were all standardized and monitored throughout the study period. Results: Out of 145 patients who underwent VIH, 21 developed a SSI (14.5%). Patients who underwent open VIH had significantly more SSIs than those who underwent laparoscopic VIH (22.1% versus 3.4%; P = 0.002). Among patients who underwent open VIH, those who developed SSI had a recorded intraoperative blood loss greater than 25 mL (68.4% versus 40.3%; P = 0.030), were more likely to have a drain placed (79.0% versus 49.3%; P = 0.021) and were more likey to be operated on by surgeons with less than 75 open VIH case experience (52.6% versus 28.4%; P = 0.048). Patient and hernia characteristics were similar between the two groups. In a multiple logistic regression analysis, the open surgical technique was associated with SSI (OR 8.03, 95% CI 2.03, 31.72; P = 0.003) while controlling for the VA medical center where the procedure was performed (P = 0.041). Conclusion: Open surgical technique and the medical center rather than patient co-morbidities or hernia characteristics are associated with the formation of postoperative SSI in VIH. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate the efficacy at 6-, 12-, and 24-month follow-up of Keep Active Minnesota (KAM), a telephone and mail-based intervention designed to promote physical activity (PA) maintenance among currently active adults age 50 to 70. Method: Participants who reported having recently increased their MVPA to a minimum of 2d/wk, 30min/bout, (N =1049) were recruited in 2004 and 2005 from one large managed care organization in Minnesota, and randomly assigned to either treatment (KAM; N =523), or Usual Care (UC; N =526) with PA assessed using the CHAMPS questionnaire, and expressed as kcal/wk energy expenditure. Results: We find a sustained, significant benefit of the intervention at 6, 12 and 24months. kcal/wk expenditure in moderate or vigorous activities was higher at 6 (p <.03, Cohen''s d 6m =.16), 12 (p <.04, d 12m =.13) and 24months (p <.01, d 24m =.16) for KAM participants, compared to UC participants. Conclusions: The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term (6months) and longer-term (12 and 24months) relative to usual care. [Copyright &y& Elsevier]

Abstract: Objective: To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse. Methods: The IMPALA study (2006, the Netherlands) was a cluster-randomised controlled trial involving 25 general practices and 615 patients who were eligible for cardiovascular risk management. The intervention consisted of (1) individual 10-year cardiovascular risk assessment, (2) risk communication, (3) use of a decision aid and (4) adapted motivational interviewing, applied by practice nurses in two consultations. Outcomes were smoking, alcohol, diet, physical activity and the secondary outcomes risk perception, anxiety, confidence about the decision and satisfaction with the communication, measured at baseline and after 12 weeks. Results: Patients of both groups improved their lifestyle, but no relevant significant differences between the groups were found. Intervention group patients improved in terms of the appropriateness of risk perception, although not significantly. Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients. Conclusion: The intervention seems to have improved the patients'' risk perception, anxiety and satisfaction with the communication, which are important conditions for shared decision making. However, we found no additional effect of the intervention on lifestyle. [Copyright &y& Elsevier]

Abstract: Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P <0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate the effectiveness of a population-based multi-factorial lifestyle intervention on long-term changes in dietary habits compared to a non-intervention control group. Methods: The study was a randomized controlled lifestyle intervention study, Inter99 (1999–2006), Copenhagen, Denmark, using a high-risk strategy. Participants in the intervention group (n =6 091) had at baseline a medical health-examination and a face-to-face lifestyle counselling. Individuals at high risk of ischemic heart disease were repeatedly offered both individual and group-based counselling. The control group (n =3 324) was followed by questionnaires. Dietary habits were measured by a validated 48-item food frequency questionnaire and changes were analyzed by multilevel analyses. Results: At the 5-year follow-up the intervention group compared to the control group had significantly increased their intake of vegetables (men: net-change: 23 g/week; p =0.04; women: net-change: 27 g/week; p =0.005) and decreased the intake of highly saturated fats used on bread and for cooking (men: OR=0.59 (0.41–0.86); women: OR=0.42 (0.30–0.59)). Significant effects on fruit and fish intake were found at the 3-year follow-up but the effect attenuated at the 5-year follow-up. Conclusion: A population-based multi-factorial lifestyle intervention promoted significant greater beneficial long-term dietary changes compared to the control group, especially the intake of vegetables and saturated fat was improved. [Copyright &y& Elsevier]

Abstract: Objective: High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated. Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in populations. The present study is a community cluster-randomised trial testing the effectiveness of CHAP (Cardiovascular Health Awareness Program) on the cardiovascular health of older adults. Methods: Thirty-nine mid-sized communities in Ontario, Canada were stratified by geographic location and size of the population aged ≥65 years and randomly allocated to receive CHAP or no intervention. In CHAP communities, residents aged ≥65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall, 2006. Sessions included blood pressure measurement and feedback to family physicians. Trained volunteers delivered the program with support from pharmacists, community nurses and local organisations. Results: The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among residents aged ≥65 years in intervention and control communities, using routinely collected, population-based administrative health data. Conclusion: This paper highlights considerations in design, implementation and evaluation of a large-scale, community-wide cardiovascular health promotion initiative. [Copyright &y& Elsevier]