***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format OBJECTIVE To test the feasibility , acceptability , and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , among African-American girls . DESIGN Twelve-week , 2-arm parallel group , r and omized controlled trial . SETTING Low-income neighborhoods . PARTICIPANTS Sixty-one 8 - 10-year-old African-American girls and their parents/guardians . INTERVENTIONS The treatment intervention consisted of after-school dance classes at 3 community centers , and a 5-lesson intervention , delivered in participants ' homes , and design ed to reduce television , videotape , and video game use . The active control intervention consisted of disseminating newsletters and delivering health education lectures . MAIN OUTCOME MEASURES Implementation and process measures , body mass index , waist circumference , physical activity measured by accelerometry , self-reported media use , and meals eaten with TV . RESULTS Recruitment and retention goals were exceeded . High rates of participation were achieved for assessment s and intervention activities , except where transportation was lacking . All interventions received high satisfaction ratings . At follow up , girls in the treatment group , as compared to the control group , exhibited trends toward lower body mass index ( adjusted difference = -.32 kg/m2 , 95 % confidence interval [ CI ] -.77 , .12 ; Cohen 's d = .38 st and ard deviation units ) and waist circumference ( adjusted difference = -.63 cm , 95 % CI -1.92 , .67 ; d = .25 ) ; increased after-school physical activity ( adjusted difference = 55.1 counts/minute , 95 % CI -115.6 , 225.8 ; d = .21 ) ; and reduced television , videotape , and video game use ( adjusted difference = -4.96 hours/week , 95 % CI -11.41 , 1.49 ; d = .40 ) . The treatment group reported significantly reduced household television viewing ( d = .73 , P = .007 ) and fewer dinners eaten while watching TV ( adjusted difference = -1.60 meals/week , 95 % CI -2.99 , -.21 ; d = .59 ; P = .03 ) . Treatment group girls also reported less concern about weight ( d = .60 ; P = .03 ) , and a trend toward improved school grade s ( d = .51 ; P = .07 ) . CONCLUSIONS This study confirmed the feasibility , acceptability , and potential efficacy of using dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , in African-American girls To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE The objective of the current study was to examine the effectiveness of a multidisciplinary weekly family-based behavioral group delivered via telemedicine to rural areas , compared with a st and ard physician visit intervention . METHODS A r and omized controlled trial was conducted with 58 rural children and their families comparing a family-based behavioral intervention delivered via telemedicine to a structured physician visit condition . Outcome measures included child body mass index z-score ( BMI z ) , 24-hr dietary recalls , accelerometer data , Child Behavior Checklist , Behavioral Pediatrics Feeding Assessment Scale , and feasibility and fidelity . RESULTS Child BMI z outcomes were not statistically different between the 2 groups ( F = 0.023 , p = .881 ) . Improvements in BMI z , nutrition , and physical activity were seen for both groups . CONCLUSIONS Both telemedicine and structured physician visit may be feasible and acceptable methods of delivering pediatric obesity treatment to rural children Summary Background Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades , scarce evidence exists for effective preventive strategies . We aim ed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months . Methods This pragmatic cluster r and omised controlled trial of the Healthy Lifestyles Programme ( HeLP ) , a school-based obesity prevention intervention , was done in 32 schools in southwest Engl and . All state-run primary and junior schools in Devon and Plymouth ( UK ) with enough pupils for at least one year-5 class were eligible . Schools were assigned ( 1:1 ) using a computer-generated sequence to either intervention or control , stratified by the number of year-5 classes ( one vs more than one ) and the proportion of children eligible for free school meals ( < 19 % [ the national average ] vs ≥19 % ) . HeLP was delivered to year-5 children ( ages 9–10 years ) over 1 year , and included dynamic and interactive activities such as physical activity workshops , education sessions delivered by teachers with short homework tasks , drama sessions , and setting goals to modify behaviour ( with parental support and one-to-one discussion s with HeLP coordinators ) . The primary outcome was change in body-mass index ( BMI ) st and ard deviation score ( SDS ) between baseline and 24 months , analysed in children with BMI data available for both timepoints . This study is registered with the International St and ard R and omised Controlled Trial register , number IS RCT N15811706 , and the trial status is complete . Findings Between March 21 , 2012 , and Sept 30 , 2013 , 32 eligible schools with 1324 children were recruited , of which 16 schools ( 676 children ) were r and omly assigned to the HeLP intervention  and 16 schools ( 648 children ) to control . All schools that began the trial completed the intervention , and 1244 children ( 628 in intervention group and 616 in control group )  had BMI data at both baseline and 24 months for the primary outcome analysis . Mean BMI SDS was 0·32 ( SD 1·16 ) at baseline and 0·35 ( 1·25 ) at 24 months in the intervention group , and 0·18 ( 1·14 ) at baseline and 0·22 ( 1·22 ) at 24 months in the control group . With adjustment for school-level clustering , baseline BMI scores , sex , cohort , and number of year-5 classes and socioeconomic status of each school , the mean difference in BMI SDS score ( intervention – control ) at 24 months was −0·02 ( 95 % CI −0·09 to 0·05 ) , p=0·57 . One parent reported an adverse event related to their child 's eating and activity behaviours , but agreed for the child to continue trial participation after discussion with the chief investigator . Interpretation Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement , follow-up , and fidelity of delivery , we found no effect of the intervention on preventing overweight or obesity . Although schools are an ideal setting in which to deliver population -based interventions , school-based interventions might not be sufficiently intense to affect both the school and the family environment , and hence the weight status of children . Future research should focus on more upstream determinants of obesity and use whole-systems approaches . Funding UK National Institute for Health Research , Public Health Research Programme Background The bias toward immediate gratification is associated with maladaptive eating behaviors and has been cross-sectionally and prospect ively related to obesity . Engaging in episodic future thinking , which involves mental self-projection to pre-experience future events , reduces this bias and energy intake in overweight/obese adults and children . To examine how episodic future thinking can be incorporated into clinical interventions , a Web-based system was created to provide training for adults and children in their everyday lives . Objective Our study examined the technical feasibility , usability , and acceptability of a Web-based system that is accessible by mobile devices and adapts episodic future thinking for delivery in family-based obesity interventions . Methods We recruited 20 parent-child dyads ( N=40 ) from the surrounding community and r and omized to episodic future thinking versus a nutritional information thinking control to test the feasibility of a 4-week Web-based intervention . Parents were 44.1 ( SD 7.8 ) years of age with BMI of 34.2 ( SD 6.8 ) kg/m2 . Children were 11.0 ( SD 1.3 ) years of age with BMI percentile of 96.0 ( SD 1.8 ) . Families met weekly with a case manager for 4 weeks and used the system daily . Adherence was collected through the Web-based system , and perceived acceptance of the Web-based system was assessed postintervention . Measurements of body composition and dietary intake were collected at baseline and after the 4 weeks of intervention . Results All 20 families completed the intervention and attended all sessions . Results showed parents and children had high adherence to the Web-based system and perceived it to be easy to use , useful , and helpful . No differences between conditions were found in adherence for parents ( P=.65 ) or children ( P=.27 ) . In addition , results suggest that basic nutrition information along with episodic future thinking delivered through our Web-based system may reduce energy intake and weight . Conclusions We showed that our Web-based system is an accepted technology and a feasible utility . Furthermore , results provide initial evidence that our system can be incorporated into family-based treatments targeting behaviors related to weight control . These results show promising utility in using our Web-based system in interventions This study explored a community-based after-school program ’s effect on obesity in minority children . Study participants included 178 third through fifth grade rs ( 47 % Latino , 25 % Asian , and 18 % African-American ) enrolled in America SCORES Bay Area . Outcomes were attendance , change in fitness ( 20-meter shuttle test ) , and body mass index ( BMI ) z-score over eight months . At baseline , 52 percent of children were overweight or obese .  Children attended SCORES > 4 days/week and fitness significantly improved ( p < 0.01 ) . BMI z-score decreased by 0.04 ( p = 0.10 ) overall , and by 0.05 ( p = 0.08 ) among obese children , but increased among African-American children . These results suggest that SCORES increases fitness and may improve BMI in some minority children . Effect modification by race may relate to differential growth patterns or engagement in SCORES . These findings suggest community-based programs could effectively address obesity . A r and omized trial of the SCORES program is warranted to rigorously examine this type of after-school program ’s impact on child health To 
    Output:
    
Pre-emptive avoidance of RGBs during the initial testing of an intervention may diminish the voltage drop between pilot and larger efficacy/effectiveness trials and enhance the odds of successful translation