Group-randomized Controlled Trial Research Articles

Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review

IntroductionBurn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials...

A group randomized control trial to test the efficacy of the Road to Mental Readiness (R2MR) program among Canadian military recruits

BackgroundDespite increased interest in workplace mental health interventions, the evidence for beneficial effects is mixed. Furthermore, many existing studies lack methodological rigor. We report results from a group randomized control trial to test the efficacy of a vastly popular intervention in Canada, the Road to Mental Readiness (R2MR) program, which has been widely disseminated in military, first responder, and civilian settings.MethodsThe trial took place among Canadian Armed Forces military recruits completing their basic military qualification (BMQ) training, and randomized 65 platoons (N = 2831) into either (a) an Intervention (R2MR at week 2 of BMQ), or (b) a delayed Intervention Control (R2MR at week 9 of BMQ) condition. The principal investigator, participants, and data collection staff were blinded to platoon condition. Individual-level psychological functioning, resilience, mental health service use attitudes, intentions, and behaviours, and additional covariates were assessed with questionnaires around week 2 (a day or two before Intervention platoons received R2MR), at week 5, and at week 9 (a day or two before the Control platoons received R2MR). Military performance outcomes were obtained from administrative databases.ResultsThe full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time. Analyses among two subsamples (Group 1: Intervention platoons with a Fidelity Check and their Controls, and Group 2: Intervention platoons without Fidelity Check and their Controls) indicated that for some outcomes (attitudes and help-seeking), under high fidelity conditions, the beneficial effects of R2MR were increased and better sustained; Conversely, under poor fidelity conditions, decreased beneficial effects or even iatrogenic effects were observed. Analyses across three training divisions indicated the larger organizational climate further influences efficacy.ConclusionsOur findings paint a very complex picture in which it is made evident that sensible, evidence-informed workplace mental health interventions such as R2MR may work under high fidelity conditions, but may yield no discernable benefit or even inadvertent iatrogenic effects if implemented poorly or without sufficient consideration to the larger organizational context.Trial registrationISRCTN 52557050 Registered 13 October 2016.

Biomarker-guided management reduces exacerbations in non-eosinophilic asthma in pregnancy: A secondary analysis of a randomized controlled trial.

The aim of this secondary analysis of a randomized controlled trial (RCT) of asthma management in pregnancy was to determine the treatment decision differences between a symptom control algorithm and a fractional exhaled nitric oxide (FENO)-guided algorithm, and whether the approach was effective in non-eosinophilic asthma (NEA). In this double-blind parallel group RCT, women with asthma were randomized prior to 22 weeks gestation to treatment adjustment according to a symptom control algorithm (control group), or a FENO-guided algorithm (inhaled corticosteroid (ICS) dose adjusted according to FENO with long-acting beta-agonist (LABA) added for uncontrolled symptoms). NEA was classified as baseline blood eosinophils <0.26 × 109 /L and FENO ≤29 ppb. Exacerbations requiring medical intervention were recorded. Among 220 non-smokers (n = 109 control, n = 111 FENO), 1006 treatment decisions were made, with significant group differences after the first and second algorithm applications. 53% of women had NEA. Treatment was better targeted to phenotype in the FENO group: ICS use increased in eosinophilic asthma (EA, 48-86%), while ICS/LABA increased in NEA (11-30%). Fewer women in the FENO group had exacerbations during pregnancy in NEA only (18.9% FENO vs 44% control, P = 0.006). The FENO algorithm was more effective in treating NEA, resulting in reduced exacerbations, compared to a symptom control algorithm. This was not the result of ICS overtreatment, since the benefits occurred at a lower median daily ICS dose. Two applications of the FENO-guided algorithm, one month apart, were sufficient to achieve beneficial effects in terms of asthma exacerbations, among pregnant women with asthma.

Eating Occasions, Obesity and Related Behaviors in Working Adults: Does it Matter When You Snack?

Reported relationships between frequency, type, and timing of eating occasions and obesity-risk among adults are mixed while associations with obesogenic eating behaviors remain unexplored. The Physical Activity and Changes in Eating (PACE) study was a group-randomized controlled trial to prevent weight gain among 34 small worksites in Seattle from 2005–2009. Baseline surveys assessed body mass index (BMI), obesogenic eating behaviors (e.g., fast food and distracted-eating), and eating occasions (i.e., snacks and meals) among 2265 employees. BMI and waist circumference were measured on a subset (n = 567). Time-periods for analyses included: morning (12:00 a.m. to 10:59 a.m.), mid-day (11:00 a.m. to 4:29 p.m.), and evening (4:30 p.m. to 11:59 p.m.). Multilevel linear models estimated associations between snack timing, obesity, and related behaviors while adjusting for meal timing, gender, and worksite random effects. Greater morning snacking was associated with increased fruit and vegetable consumption, while greater evening snacking was associated with higher BMI, higher obesogenic dietary index (intake of fast food, French fries, and soft drinks), and higher percent time eating while distracted. Associations with mid-day snacking were mixed. Patterns of association were consistent across repeated and objective measures. Findings suggest that evening snacking is more detrimental to healthy weight compared to snacking at other times of day. Reducing evening snacks may be an important and simple message for population-level obesity prevention efforts.

Researching the Effectiveness of Tree of Life: an Imbeleko Approach to Counseling Refugee Youth.

With the growing worldwide refugee crisis, there is a need for evidence-based interventions that specifically deal with the consequences of cumulative trauma-exposure in refugee youth. Refugee children have unique service needs and differ from their non-refugee peers in terms of sociocultural trauma, language, culture, and educational barriers. This article explains the complexities associated with understanding refugee youth and presents a proposal for studying the possible benefits of Tree of Life therapy. At the present time, Tree of Life therapy has no evidence-base because the published studies of Tree of Life with refugee and/or immigrant youth have sample sizes of one, six, eight, and twenty-nine. As a culturally-grounded, strength-based group counseling approach, Tree of Life therapy addresses traumatic experiences, recognizes participants' cultural differences, highlights individual skills, and aids in instilling both confidence and hope for the future. Ncazelo Ncube, the co-founder and main developer of Tree of Life, describes this therapy as a collective narrative practice that considers cultural beliefs and values (2006, 2010, 2018, 2019). The proposed research design is to study the effectiveness of the Tree of Life in Canada, the United States, the United Kingdom, and South Africa. The research plan is to use pragmatic, group-randomized controlled trials in the "real world" settings of schools and agencies in each of the four countries. In addition, the article describes the development of the Roots and Wings Questionnaire for Children and Youth, a culturally relevant, child-friendly questionnaire. The Tree of Life is a readily available therapy with great potential for helping traumatized refugee youth as well as other trauma-impacted young people worldwide.

Adolescent Dating Violence Prevention Program for Early Adolescents: The Me & You Randomized Controlled Trial, 2014-2015.

Objectives. To test the efficacy of Me & You, a multilevel technology-enhanced adolescent dating violence (DV) intervention, in reducing DV perpetration and victimization among ethnic-minority early adolescent youths. We assessed secondary impact for specific DV types and psychosocial outcomes.Methods. We conducted a group-randomized controlled trial of 10 middle schools from a large urban school district in Southeast Texas in 2014 to 2015. We used multilevel regression modeling; the final analytic sample comprised 709 sixth-grade students followed for 1 year.Results. Among the total sample, odds of DV perpetration were lower among intervention students than among control students (adjusted odds ratio = 0.46; 95% confidence interval = 0.28, 0.74). Odds of DV victimization were not significantly different. There were significant effects on some specific DV types.Conclusions. Me & You is effective in reducing DV perpetration and decreasing some forms of DV victimization in early middle-school ethnic-minority students.

WITHDRAWN: Operative caries management in adults and children.

WITHDRAWN: Operative caries management in adults and children.

Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial

BackgroundFun For Wellness (FFW) is an online behavioral intervention developed to encourage growth in well-being by providing capability-enhancing learning opportunities to participants. Self-efficacy theory guides the conceptual model underlying the FFW intervention. Some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions. The purpose of this paper is to describe the protocol for a new randomized controlled trial (RCT) designed to provide the first investigation of the effectiveness of FFW to increase well-being and physical activity in adults with obesity in the United States of America.MethodsThe study design is a large-scale, prospective, parallel group RCT. Approximately 9 hundred participants will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e., FFW:UC) assignment. Participants will be recruited through an online panel recruitment company. Data collection, including determination of eligibility, will be conducted online and enrollment is scheduled to begin on 8 August 2018. Data collection will occur at baseline, 30 days and 60 days after baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity and well-being will be included in the battery. Data will be modeled under an intent to treat approach and/or a complier average causal effect approach depending on the level of observed engagement with the intervention.DiscussionThe effectiveness trial described in this paper builds upon the 2015 FFW efficacy trial and has the potential to be important for at least three reasons. The first reason is based upon a general scientific approach that the potential utility of interventions should be evaluated under both ideal (e.g., more controlled) and real-world (e.g., less controlled) conditions. The second reason is based upon the global need for readily scalable online behavioral interventions that effectively promote physical activity in adults. The third reason is based upon the troubling global trend toward obesity along with evidence for obesity as a risk factor for several major non-communicable diseases.Trial registrationClinicalTrials.gov, identifier: NCT03194854, registered 21 June 2017.

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

Background and objectivesThe number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases.Methods/designThis two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records.DiscussionThis trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded.Trial registrationClinicalTrials.gov, NCT03511508. Registered April 27, 2018.

¡Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion in secondary school students in Uruguay.

¡Activate Ya! was a group-randomized controlled intervention trial aimed at developing and evaluating the impact of a school-based intervention on preventing cigarette smoking and promoting physical activity (PA) in secondary school students in Uruguay. Secondary aims were to evaluate the program's impact on students' smoking- and PA-related psychosocial risk and protective factors. Sixteen schools and n = 654 students participated in the study. The one-year intervention included a classroom-based curriculum, an afterschool program, activity breaks, and final showcase event. A self-administered questionnaire measured outcomes at three time points. Fixed effects regression models tested for differences in outcomes by study condition. While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected. Past 7-day PA, measured by the PAQ-C, was significantly higher among intervention school students overall (p = .048) and for girls (p = .03) at posttest, and intervention girls reported significantly higher athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment at follow-up (p < .05). The positive short-term effects of ¡Activate Ya! on PA and related outcomes for girls support the utility of school-based health promotion in Uruguay. Additional research is needed to determine the most effective strategies to prevent tobacco use among students and promote PA among boys in this setting.

Cognitive Behavioral Treatment for Acute Posttrauma Distress: A Randomized, Controlled Proof-of-Concept Study Among Hospitalized Adults With Burns

Objective(1) To evaluate the feasibility of conducting a randomized controlled trial (RCT) of the Safety, Meaning, Activation and Resilience Training (SMART) intervention vs nondirective supportive psychotherapy (NDSP) in an acutely hospitalized adult survivor of burn injury sample; and (2) to assess the preliminary effect of SMART on acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and major depressive disorder (MDD) symptom reduction as secondary prevention. DesignProof-of-concept, parallel group RCT design. SettingRegional burn center. ParticipantsAcutely injured, hospitalized adult survivors of burn injury (N=50) were randomly assigned to SMART (n=28) or nondirective supportive psychotherapy (n=22). Due to dropout and missing data, final sample size was 40, SMART (n=21) and nondirective supportive psychotherapy (n=19). InterventionsSMART is a manualized, 4-session cognitive behavioral therapy-based psychological intervention targeting ASD, PTSD, and MDD symptoms. NDSP is a manualized, 4-session protocol. Main Outcome MeasuresDavidson Trauma Scale ([DTS]; diagnostic proxy for ASD and PTSD; clinical cutoff=40, with higher score=higher severity) and the Patient Health Questionnaire-9 ([PHQ-9]; diagnostic proxy for MDD; clinical cutoff=10, with higher score=higher severity) at pretreatment, immediate posttreatment, and 1 month posttreatment. ResultsAt baseline, median DTS scores and PHQ-9 scores were above clinical cutoffs and did not differ across groups. At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points. ConclusionsIt is feasible to conduct an RCT of SMART in hospitalized adult survivors of burn injury. SMART has the potential to yield clinically significant outcomes. Additional studies are needed to replicate and extend these findings.

A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers

IntroductionImproving children's tap water intake and reducing sugar-sweetened beverage (SSB) consumption is beneficial for health and health equity, particularly in low-income communities and communities of color. Existing community level interventions to improve the intake of tap water have predominantly occurred in schools and have focused on promoting water consumption in cafeterias during lunch or snack periods. MethodsThe “Hydrate Philly” intervention was developed to target multiple environmental and social factors to improve tap water consumption in community recreation centers in low-income communities: replacing old and unappealing water fountains with appealing water-bottle-filling “hydration stations”, conducting water safety testing and publicizing results, disseminating reusable water bottles, promoting tap water, and discouraging SSB consumption. Efficacy of the intervention will be tested through a group-randomized controlled trial (n = 28 centers) of the intervention's impact on center-level water fountain/station use as measured by flow meters during a youth summer camp program primarily for children aged 6–12 years. Intervention impact on the primary outcome (use of drinking water sources) will be examined with a difference-in-differences approach using an ordinary least squares regression model for analysis at the center level. Secondary outcomes include SSBs brought to summer camp, reusable and single-use bottled water use, program trash, and recreation center staff SSB consumption. DiscussionMultilevel approaches are needed to increase tap water intake and decrease SSB consumption among low-income and minority youth beyond school and meal settings. The current study describes the Hydrate Philly intervention, the study design, and baseline characteristics of recreation centers participating in the study.ClinicalTrials.gov Registration: #NCT03637465

Strengthening resilience in military officer cadets: A group-randomized controlled trial of coping and emotion regulatory self-reflection training.

This group-randomized control trial examined the efficacy of guided coping and emotion regulatory self-reflection as a means to strengthen resilience by testing the effects of the training on anxiety and depression symptoms and perceived stressor frequency after an intensive stressor period. The sample was 226 officer cadets training at the Royal Military College, Australia. Cadets were randomized by platoon to the self-reflection (n = 130) or coping skills training (n = 96). Surveys occurred at 3 time points: baseline, immediately following the final reflective session (4-weeks postbaseline), and longer-term follow-up (3-months postinitial follow-up). There were no significant baseline differences in demographic or outcome variables between the intervention groups. On average, cadets commenced the resilience training with mild depression and anxiety symptoms. Analyses were conducted at the individual-level after exploring group-level effects. No between-groups differences were observed at initial follow-up. At longer-term follow-up, improvements in mental health outcomes were observed for the self-reflection group, compared with the coping skills group, on depression (Cohen's d = 0.55; 95% CI [0.24, 0.86]), anxiety symptoms (Cohen's d = 0.69; 95% CI [0.37, 1.00]), and perceived stressor frequency (Cohen's d = 0.46; 95% CI [0.15, 0.77]). Longitudinal models demonstrated a time by condition interaction for depression and anxiety, but there was only an effect of condition for perceived stressor frequency. Mediation analyses supported an indirect effect of the intervention on both anxiety and depression via perceived stressor frequency. Findings provide initial support for the use of guided self-reflection as an alternative to coping skills approaches to resilience training. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

The impact of a multilevel childhood obesity prevention intervention on healthful food acquisition, preparation, and fruit and vegetable consumption on African-American adult caregivers.

To evaluate the secondary impact of a multilevel, child-focused, obesity intervention on food-related behaviours (acquisition, preparation, fruit and vegetable (FV) consumption) on youths' primary caregivers. B'More Healthy Communities for Kids (BHCK) group-randomized controlled trial promoted access to healthy foods and food-related behaviours through wholesaler and small store strategies, peer mentor-led nutrition education aimed at youths, and social media and text messaging targeting their adult caregivers. Measures included caregivers' (n 516) self-reported household food acquisition frequency for FV, snacks and grocery items over 30 d, and usual FV consumption in a sub-sample of 226 caregivers via the NCI FV Screener. Hierarchical models assessed average treatment effects (ATE). Treatment-on-the-treated-effect (TTE) analyses evaluated correlation between behavioural change and exposure to BHCK. Exposure scores at post-assessment were based on self-reported viewing of BHCK materials and participating in activities. Thirty Baltimore City low-income neighbourhoods, USA.ParticipantsAdult caregivers of youths aged 9-15 years. Of caregivers, 90·89 % were female; mean age 39·31 (sd 9·31) years. Baseline mean (sd) intake (servings/d) was 1·30 (1·69) fruits and 1·35 (1·05) vegetables. In ATE, no significant intervention effect was found on caregivers' food-related behaviours. In TTE, each point increase in BHCK exposure score (range: 0-6·9) increased caregivers' daily fruit consumption by 0·2 servings (0·24 (se 0·11); 95 % CI 0·04, 0·47). Caregivers reporting greater social media exposure tripled their daily fruit intake (3·16 (se 0·92); 95 % CI 1·33, 4·99) and increased their frequency of unhealthy food purchasing v. baseline. Child-focused community-based nutrition interventions may also benefit family members' fruit intake. Child-focused interventions should involve adult caregivers and intervention effects on family members should be assessed. Future multilevel studies should consider using social media to improve reach and engage caregiver participants.

A multilevel, multicomponent childhood obesity prevention group-randomized controlled trial improves healthier food purchasing and reduces sweet-snack consumption among low-income African-American youth

BackgroundConsumption of foods and beverages rich in sugar remains high across all races and ages in the United States. Interventions to address childhood obesity and decrease sugar intake are needed, particularly in low-income settings.MethodsB’more Healthy Communities for Kids (BHCK) was a group-randomized, controlled trial implemented among 9–15-year olds in 30 low-income areas of Baltimore. We increased access to low-sugar foods and beverages at wholesalers and small food stores. Concurrently, we encouraged their purchase and consumption by children through youth-led nutrition education in recreation centers, in-store promotions, text messaging and a social media program directed at caregivers. Sugar consumption (sugar sweetened beverage (SSB), sweets) in youth was assessed pre- (n = 534) and post-intervention (n = 401) using the Block Kids Food Frequency Questionnaire. Purchasing of 38 healthier and 28 less healthier food/beverage varieties in the previous 7 days was assessed via self-report. Multilevel models at the community and individual levels were used. Analyses were stratified by age (younger: 9–12-year olds (n = 339) vs older: 13–15 (n = 170)). Models were controlled for child’s sex, race, total daily caloric intake, and caregiver’s age and sex.ResultsOverall baseline mean healthier food purchasing was 2.5 (+ 3.6; min. 0, max. 34 items per week), and unhealthier food purchasing 4.6 (+ 3.7; 0–19 items per week). Mean intake at baseline for kcal from SSB was 176 (+ 189.1) and 153 (+ 142.5), and % of calories from sweets (i.e. cookies, cakes, pies, donuts, candy, ice cream, sweetened cereals, and chocolate beverages) was 15.9 (+ 9.7) and 15.9 (+ 7.7) in comparison and intervention youth, respectively. Intervention youth increased healthier foods and beverages purchases by 1.4 more items per week than comparison youth (β = 1.4; 95% CI: 0.1; 2.8). After the intervention, there was a 3.5% decrease in kcal from sweets for older intervention youth, compared to the control group (β = − 3.5; 95% CI: -7.76; − 0.05). No impact was seen on SSB consumption.ConclusionBHCK successfully increased healthier food purchasing variety in youth, and decreased % calories from sweet snacks in older youth. Multilevel, multicomponent environmental childhood obesity programs are a promising strategy to improve eating behaviors among low-income urban youth.Trial registrationNCT02181010 (July 2, 2014, retrospectively registered).

Yoga practice to improve sleep quality and body composition parameters of obese male - a randomized controlled trial.

Background Globally obesity increase is a big challenge. Obesity causes many non-communicable diseases. Options to control obesity are in search. Aim: To assess the outcome of 3 months follow-up period, after 14 weeks yoga intervention, for body composition and sleep quality parameters on obese male in urban setting. Materials and methods Design: Parallel group RCT (randomized controlled trial) on obese male. The two groups were yoga and control groups, with yoga (n = 37, age 40.03 ± 8.74), control (n = 35, age 42.20 ± 12.06). The IAYT (integrated approach of yoga therapy) training was given to yoga group for 14 weeks, and the unsupervised yoga practice was continued by the subjects at their home, for further 3 months. Training was 1.5 hour daily for 5 days in a week, which included the IAYT module of Suryanamaskara Asana Pranayama and relaxation. No yoga activity but walking etc. for the same time, was given to control group. Body composition parameters were assessed through BIA (bioelectrical impedance) method using InBody R 20 model. The sleep quality was assessed using PSQI (Pittsburgh sleep quality index). Within group and between group analysis were performed, using SPSS version 21. The correlation analysis was carried out on the difference in pre follow-up values. Results During the follow-up period within the group, the body composition parameters improved and the parameters of quality of sleep showed trends of improvement. Also some of the gain obtained during 14 weeks intervention was lost during follow-up period. Conclusions The changes observed may indicate the long-term benefits of yoga practice for control of obesity in urban setting for males.

Effects of a Collaborative Board Game on Bullying Intervention: A Group-Randomized Controlled Trial.

We examined the effects of the Galaxy Rescuers game, a collaborative board game on schoolchildren's bullying intervention. We conducted a group-randomized controlled trial. We recruited 328 fifth graders at an elementary school in northern Taiwan. The study took place in fall 2015 over a 7-week period. We used the generalized estimation equation (GEE) to evaluate the intervention effects on students' scores on the outcome measures. At posttest, the change in bullying knowledge was statistically significant for the game-only group and the game-with-debriefing group. Students in the game-with-debriefing group also showed an increase in empathy and a decrease in bullying attitude. At the follow-up test, knowledge increase remained significant for both the game-only group and the game-with-debriefing group. Game satisfaction survey indicated that 66.8% of the players said that the game was enjoyable. The Galaxy Rescuers game is effective in changing players' bullying knowledge, attitude, and empathy. This game is an entertaining tool for promoting awareness of bullying and encouraging defending atmosphere among children.

PS02.116: FEASIBILITY OF DOCETAXEL, CISPLATIN, AND 5-FLUOROURACIL (DCF) VERSUS RADIOTHERAPY WITH DCF (DCF-RT) AS PREOPERATIVE THERAPY FOR LOCALLY ADVANCED ESOPHAGEAL CANCER

Abstract Background In Japan, preoperative chemotherapy with cisplatin plus 5-fluorouracil (CF) followed by radical surgery has been accepted as the standard therapeutic approach for resectable esophageal squamous cell carcinoma (ESCC) result from a Japan Clinical Oncology Group randomized control trial. Whether preoperative chemoradiotherapy (CRT) followed by radical surgery is effective for Japanese ESCC patients has yet to be established. Some trials have reported usefulness of CF plus docetaxel therapy (DCF) for advanced or metastatic ESCC. Here, we have launched a randomized controlled trial to compare preoperative DCF versus DCF plus radiotherapy (DCF-RT) followed by surgery in locally advanced esophageal cancer. Methods Patients with clinical stage II/III (Japanese Classification of Esophageal Cancer, 11th Edition) are randomized to 2 groups. Patients in DCF group receive 2 courses of preoperative DCF (docetaxel, 60 mg/m2/day, day 1; cisplatin, 70 mg/m2/day, day 1; 5-FU, 700 mg/m2/day, days 1–5) repeated every 3 weeks. Patients in DCF-RT group receive preoperative chemoradiotherapy (40Gy/20fr) with 2 courses of DCF (docetaxel, 30 mg/m2/day, day 1, 15; cisplatin, 7 mg/m2/day and 5-FU, 350 mg/m2/day, days 1–5, days 8–12, days 15–19, days 22–26). The primary endpoint is overall survival and the secondary endpoints include adverse events, response rate and pathologic complete response rate. Results Twenty-seven patients were assigned to the DCF group and 26 patients to the DCF-RT group. Grade 3/4 leukopenia and febrile neutropenia occurred 37% and 19% in the DCF group, 35% and 12% in the DCF-RT group. The clinical response rates were 16.0% and 64.0% in the DCF and DCF-RT group. Twenty patients and 23 patients underwent surgery in the DCF and DCF-RT group, and the R0 resection rate was 80.0% and 91.3%. With regard to the surgical complications, the incidence of anastomotic leakage was significantly higher in the DCF-RT group compared with the DCF group. The histological effects of DCF-RT were significantly higher than those of DCF. Two-year survival rate was 46% in the DCF group and 70% in the DCF-RT group. Conclusion The DCF and DCF-RT were found to be feasible as neoadjuvant therapy, and DCF-RT demonstrated higher efficacy than DCF in clinical stage II/III esophageal cancer patients. Disclosure All authors have declared no conflicts of interest.

Impact of the Out-of-School Nutrition and Physical Activity (OSNAP) Group Randomized Controlled Trial on Children’s Food, Beverage, and Calorie Consumption among Snacks Served

BackgroundAfterschool interventions have been found to improve the nutritional quality of snacks served. However, there is limited evidence on how these interventions affect children’s snacking behaviors. ObjectiveOur aim was to determine the impact of an afterschool intervention focused at the school district, site, family, and child levels on dietary consumption of foods and beverages served at snack. DesignThis was a secondary analysis of a group-randomized controlled trial. Participants/settingData were collected from 400 children at 20 afterschool sites in Boston, MA before (fall 2010) and after (spring 2011) intervention implementation. InterventionThe Out-of-School Nutrition and Physical Activity intervention aimed to promote fruits, vegetables, whole grains, and water, while limiting sugary drinks and trans fats. Researchers worked with district foodservice staff to change snack foods and beverages. Teams of afterschool staff participated in three 3-hour learning collaborative sessions to build skills and created action plans for changing site practices. The intervention included family and child nutrition education. Main outcome measuresResearch assistants observed dietary snack consumption using a validated measure on 2 days per site at baseline and follow-up. Statistical analyses performedThis study used multivariable regression models, accounting for clustering of observations, to assess the intervention effect, and conducted post-hoc stratified analyses by foodservice type. ResultsChildren in intervention sites had greater decreases in consumption of juice (–0.61 oz/snack, 95% CI –1.11 to –0.12), beverage calories (–29.1 kcal/snack, 95% CI –40.2 to 18.0), foods with trans fats (–0.12 servings/snack, 95% CI –0.19 to –0.04), total calories (–47.7 kcal/snack, 95% CI –68.2 to –27.2), and increases in consumption of whole grains (0.10 servings/snack, 95% CI 0.02 to 0.18) compared to controls. In post-hoc analyses, sites with on-site foodservice had significant improvements for all outcomes (P<0.001), with no effect for sites with satellite foodservice. ConclusionsResults demonstrate that an afterschool intervention can improve children’s dietary snack consumption, particularly at sites with on-site foodservice.

Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial

IntroductionPterygium is a non-cancerous growth of the conjunctival tissue over the cornea that may lead to visual impairment in advanced stages, restriction of ocular motility, chronic inflammation and cosmetic concerns....