The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials Effectiveness of intensive group and individual interventions for smoking cessation in primary health care settings: a randomized trial Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial Employing external facilitation to implement cognitive behavioral therapy in VA clinics: a pilot study Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Effect of an individually tailored one-year energy balance programme on body weight, body composition and lifestyle in recent retirees: a cluster randomised controlled trial An intervention to stop smoking among patients suspected of TB - evaluation of an integrated approach Evidence-based behavioral medicine: What is it and how do we achieve it? Identifying Evidence-Based Competences Required to Deliver Behavioural Support for Smoking Cessation Using the theory of planned behaviour as a process evaluation tool in randomised trials of knowledge translation strategies: A case study from UK primary care Incentive payments to general practitioners aimed at increasing opportunistic testing of young women for chlamydia: a pilot cluster randomised controlled trial Healthy eating and obesity prevention for preschoolers: a randomised controlled trial A group-randomized controlled trial for health promotion in Girl Scouts: Healthier Troops in a SNAP (Scouting Nutrition & Activity Program) Effectiveness of a parenting programme in a public health setting: a randomised controlled trial of the positive parenting programme (Triple P) level 3 versus care as usual provided by the preventive child healthcare (PCH) The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial Part I, Patient perspective: activating patients to engage their providers in the use of evidence-based medicine: a qualitative evaluation of the VA Project to Implement Diuretics (VAPID) The Reinforcing Therapist Performance (RTP) experiment: Study protocol for a cluster randomized trial Reporting of interventions in randomised trials: an audit of journal Instructions to Authors The study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants Use of a liquid nicotine delivery product to promote smoking cessation Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial The Sydney Diabetes Prevention Program: A community-based translational study A pilot study combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention Semantic cuing and the scale insensitivity of recency and contiguity. Impact of a physical activity intervention program on cognitive predictors of behaviour among adults at risk of Type 2 diabetes (ProActive randomised controlled trial) Implementation of a self-management support approach (WISE) across a health system: a process evaluation explaining what did and did not work for organisations, clinicians and patients Motivational interviewing for screening and feedback and encouraging lifestyle changes to reduce relative weight in 4-8 year old children: design of the MInT study A primary health-care intervention on pre- and postnatal risk factor behavior to prevent childhood allergy. The Prevention of Allergy among Children in Trondheim (PACT) study A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3- to 5-year-old children: study protocol Marketing depression care management to employers: design of a randomized controlled trial Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol Development and exploratory cluster-randomised opportunistic trial of a theory-based intervention to enhance physical activity among adolescents The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol
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 Objectives Primary : To compare the effectiveness of intensive group and individual interventions for  smoking cessation in a primary health care setting ; secondary : to identify the variables associated with smoking cessation . Methods Three-pronged clinical trial with r and omisation at the individual level . We performed the following : an intensive individual intervention ( III ) , an intensive group intervention ( IGI ) and a minimal intervention ( MI ) . Included in the study were smokers who were prepared to quit smoking . Excluded from the study were individuals aged less than 18 years or with severe mental conditions or terminal illnesses . The outcome measure was continued abstinence at 12 months confirmed through CO-oximetry ( CO ) . The analysis was based on intention to treat . Results In total , 287 smokers were recruited : 81 in the III , 111 in the IGI , and 95 in the MI .  Continued abstinence at 12 months confirmed through CO was 7.4 % in the III , 5.4 % in the IGI , and 1 % in the MI . No significant differences were noted between III and MI on the one h and , and between IGI and MI on the other [ RR 7.04 ( 0.9 - 7.2 ) and RR 5.1 ( 0.6 - 41.9 ) , respectively ] . No differences were noted between IGI and III [ RR 0.7 ( 0.2 - 2.2 ) ] . In multivariate analysis , only overall visit length showed a statistically significant association with smoking cessation . Conclusions The effectiveness of intensive smoking interventions in this study was lower than expected . No statistically significant differences were found between the results of individual and group interventions .Trial registration numberIS RCT Background Drug related problems ( DRPs ) are common among elderly patients who are discharged from the hospital and are using several drugs for their chronic diseases . Examples of drug related problems are contra-indications , interactions , adverse drug reactions and inefficacy of treatment . Causes of these problems include prescription errors and non-compliance with treatment . The aim of this study is to examine the effect of medication review and cognitive behaviour therapy of discharged patients by community pharmacists to minimize the occurrence of drug related problems . Methods / Design A r and omized controlled trial will be performed . Community pharmacists will be r and omized into a control group and an intervention group . 342 Patients , aged over 60 years , discharged from general and academic hospitals , using five or more prescription drugs for their chronic disease will be asked by their pharmacy to participate in the study . Patients r and omized to the control group will receive usual care according to the Dutch Pharmacy St and ard . The medication of patients r and omised to the intervention group will be review ed by the community pharmacist with use of the national guidelines for the treatment of diseases , when patients are discharged from the hospital . The Pharmaceutical Care network Europe Registration form will be used to record drug related problems . Trained pharmacy technicians will counsel patients at home at baseline and at 1,3,6,9 and 12 months , using Cognitive Behaviour Treatment according to the Theory of Planned Behaviour . The patient 's attitude towards medication and patient 's adherence will be subject of the cognitive behaviour treatment . The counselling methods that will be used are motivational interviewing and problem solving treatment . Patients adherence towards drug use will be determined with use of the Medication Adherence Report Scale Question naire . There will be a follow-up of 12 months . The two primary outcome measures are the difference in occurrence of DRPs between intervention and control group and adherence with drug use . Secondary endpoints are attitude towards drug use , incidence of Re-hospitalisations related to medicines , functional status of the patient , quality of life and the cost-effectiveness of this intervention . Discussion Combining both medication review and Cognitive Behaviour Treatment may decrease DRPs and may result in more compliance with drug use among patients discharged from the hospital and using 5 or more chronic drugs . Trial registration Dutch Trial Register Background Although for more than a decade healthcare systems have attempted to provide evidence -based mental health treatments , the availability and use of psychotherapies remains low . A significant need exists to identify simple but effective implementation strategies to adopt complex practice s within complex systems of care . Emerging evidence suggests that facilitation may be an effective integrative implementation strategy for adoption of complex practice s. The current pilot examined the use of external facilitation for adoption of cognitive behavioral therapy ( CBT ) in 20 Department of Veteran Affairs ( VA ) clinics . Methods The 20 clinics were paired on facility characteristics , and 23 clinicians from these were trained in CBT .  A clinic in each pair was r and omly selected to receive external facilitation . Quantitative methods were used to examine the extent of CBT implementation in 10 clinics that received external facilitation compared with 10 clinics that did not , and to better underst and the relationship between individual providers ' characteristics and attitudes and their CBT use . Costs of external facilitation were assessed by tracking the time spent by the facilitator and therapists in activities related to implementing CBT . Qualitative methods were used to explore context ual and other factors thought to influence implementation . Results Examination of change scores showed that facilitated therapists averaged an increase of 19 % [ 95 % CI : ( 2 , 36 ) ] in self-reported CBT use from baseline , while control therapists averaged a 4 % [ 95 % CI : ( -14 , 21 ) ] increase . Therapists in the facilitated condition who were not providing CBT at baseline showed the greatest increase ( 35 % ) compared to a control therapist who was not providing CBT at baseline ( 10 % ) or to therapists in either condition who were providing CBT at baseline ( average 3 % ) . Increased CBT use was unrelated to prior CBT training . Barriers to CBT implementation were therapists ' lack of control over their clinic schedule and poor communication with clinical leaders . Conclusions These findings suggest that facilitation may help clinicians make complex practice changes such as implementing an evidence -based psychotherapy . Furthermore , the substantial increase in  CBT usage among the facilitation group was achieved at a modest cost Background Despite concerns that facilitating informed choice would decrease diabetes screening uptake , ' informed choice ' invitations that increased knowledge did not affect attendance ( the DICISION trial ) . We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations . We tested a model of the impact on knowledge , attitude and intentions of a diabetes screening invitation design ed to facilitate informed choices . Methods 417 men and women aged 40 - 69 recruited from town centres in the UK were r and omised to receive either an invitation for diabetes screening design ed to facilitate informed choice or a st and ard type of invitation .  Knowledge of the invitation , attitude towards diabetes screening , and intention to attend for diabetes screening were assessed two weeks later . Results Attitude was a strong predictor of screening intentions ( β = .64 , p = .001 ) . Knowledge added to the model but was a weak predictor of intentions ( β = .13 , p = .005 ) . However , invitation type did not predict attitudes towards screening but did predict knowledge ( β = -.45 , p = .001 ) , which mediated a small effect of invitation type on intention ( indirect β = -.06 , p = .017 ) . Conclusions These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in r and omised trials , identify which elements are most frequently missing , and assess whether authors can provide missing details . Design Analysis of consecutive sample of r and omised trials of non-pharmacological interventions . Data sources and study selection All reports of r and omised trials of non-pharmacological interventions published in 2009 in six leading general medical journals ; 133 trial reports , with 137 interventions , met the inclusion criteria . Data collection Using an eight item checklist , two raters assessed the primary full trial report , plus any reference material s , appendices , or websites . Questions about missing details were emailed to corresponding authors , and relevant items were then reassessed . Results Of 137 interventions , only 53 ( 39 % ) were adequately described ; this was increased to 81 ( 59 % ) by using 63 responses from 88 contacted authors . The most frequently missing item was the “ intervention material s ” ( 47 % complete ) , but it also improved the most after author response ( 92 % complete ) . Whereas some authors ( 27/70 ) provided material s or further information , other authors ( 21/70 ) could not ; their reasons included copyright or intellectual property concerns , not having the material s or intervention details , or being unaware of their importance . Although 46 ( 34 % ) trial interventions had further information or material s readily available on a website , many were not mentioned in the report , were not freely accessible , or the URL was no longer functioning . Conclusions Missing essential information about interventions is a frequent , yet remediable , contributor to the worldwide waste in research funding . If trial reports do not have a sufficient description of interventions , other research ers can not build on the findings , and clinicians and patients can not reliably implement useful interventions . Improvement will require action by funders , research ers , and publishers , aided by long term repositories of material s linked to publications 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 Background The increased prevalence of overweight and obesity warrants preventive actions , particularly among people in transitional stages associated with lifestyle changes , such as occupational retirement . The purpose is to investigate the effect of a one year low-intensity computer-tailored energy balance programme among recent retirees on waist circumference , body weight and body composition , blood pressure , physical activity and dietary intake . Methods A r and omised controlled trial was conducted among recent retirees ( N = 413 ; mean age 59.5 years ) . Outcome measures were assessed using anthropometry , bio-impedance , blood pressure measurement and question naires . Results Waist circumference , body weight and blood pressure decreased significantly in men of the intervention and control group , but no significant between-group-differences were observed at 12 or at 24-months follow-up . A significant effect of the programme was only observed on waist circumference ( -1.56 cm ( 95%CI : -2.91 to -0.21 ) ) at 12 month follow up among men with low education ( n = 85 ) . Physical activity and dietary behaviours improved in both the intervention and control group during the intervention period . Although , these behaviours changed more favourably in the intervention group , these between-group-differences were not statistically significant . Conclusions The multifaceted computer-tailored programme for recent retirees did not appear to be effective . Apparently the transition to occupational retirement and /or participation in the study had a greater impact than the intervention programme . Trial registration Clinical Trials NCT00122213 Background In many low- and middle-income countries , where tobacco use is common , tuberculosis is also a major problem . Tobacco use increases the risk of developing tuberculosis , secondary mortality , poor treatment compliance and relapses . In countries with TB epidemic , even a modest relative risk leads to a significant attributable risk . Treating tobacco dependence , therefore , is likely to have benefits for controlling tuberculosis in addition to reducing the non-communicable disease burden associated with smoking . In poorly re source d health systems which face a dual burden of disease secondary to tuberculosis and tobacco , an integrated approach to tackle tobacco dependence in TB control could be economically desirable . During TB screening , health professionals come across large numbers of patients with respiratory symptoms , a significant proportion of which are likely to be tobacco users . These clinical encounters , considered to be " teachable moments " , provide a window of opportunity to offer treatment for tobacco dependence . Methods / Design We aim to develop and trial a complex intervention to reduce  tobacco dependence among TB suspects based on the WHO ' five steps to quit ' model . This model relies on assessing personal motivation to quit tobacco use and uses it as the basis for assessing suitability for the different therapeutic options for tobacco dependence . We will use the Medical Research Council framework approach for evaluating complex interventions to : ( a ) design an evidence -based treatment package ( likely to consist of training material s for health professionals and education tools for patients ) ; ( b ) pilot the package to determine the delivery modalities in TB programme ( c ) assess the incremental cost-effectiveness of the package compared to usual care using a cluster RCT design ; ( d ) to determine barriers and drivers to the provision of treatment of tobacco dependence within TB programmes ; and ( e ) support long term implementation . The main outcomes to assess the effectiveness would be point abstinence at 4 weeks and continuous abstinence up to 6 months . Discussion This work will be carried out in Pakistan and is expected to have relevance for other low and middle income countries with high tobacco use and TB incidence . This will enhance our knowledge of the cost-effectiveness of treating tobacco dependence in patients suspected of TB.Trial Registration Trial Registration Number : IS RCT The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care .  Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Background No systematic basis has yet been published for specifying competences needed to underpin behavioural support for  smoking cessation . Purpose The purpose of this study was to develop and apply a system for identifying competences required for the delivery of individual and group-based behavioural support for smoking cessation . Methods Sets of recommended competences for behavioural support were identified from a range of guidance documents . Where possible , these were compared with ones based on behaviour change techniques identified within behavioural support programmes found to be effective in r and omised controlled trials ( RCTs ) and , for individual behavioural support , ones associated with higher success rates in the English Stop Smoking Services . Results Ninety-four competences were identified ( 71 individual and 23 additional group competences ) , of which 59 were cited in at least two guidance documents ( 51 and 8 , respectively ) . Fourteen of the individual competences and three of the group competences were supported by RCT evidence and , for individual competences , nine were supported by evidence from the services . Conclusions It is possible to identify competences recommended for behavioural support for smoking cessation and subsets supported by different types of evidence . This approach can form the basis for the development of assessment and training of stop smoking practitioners and is currently doing so in a national programme in Engl and . With further research , the list of evidence -based competences is likely to be extended Background R and omised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness , but offer little insight into the causal mechanisms by which any change is produced . To illustrate the applicability of causal methods within r and omised trials , we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors ' predicted their test requesting behaviours and , secondly , whether the trial results were mediated by the theoretical constructs . Methods The process evaluation comprised a cross-sectional question naire survey of a r and om 50 % sample of the r and omised groups of primary care practice s in Grampian ( NHS Grampian ) , UK , who took part in a trial of the effect of enhanced feedback and brief educational reminders on test requesting behaviour . The process evaluation was based upon the Theory of Planned Behaviour and focussed on three of the test requesting behaviours that were targeted in the trial -- ferritin , follicle stimulating hormone ( FSH ) , and Helicobacter Pylori serology ( HPS ) . Results The question naire was completed by 131 primary care doctors ( 56 % ) from 42 ( 98 % ) of the sample d practice s.  Behavioural intention , attitude , and subjective norm were highly correlated for all the tests . There was no evidence that perceived behavioural control was correlated with any of the other measures . Simple linear regression analysis of the rate of test requests on minimum behavioural intentions had R2 of 11.1 % , 12.5 % , and 0.1 % for ferritin , FSH , and HPS requesting , respectively . Mediational analysis showed that the trial results for ferritin and FSH were partially mediated ( between 23 % and 78 % mediation ) through intentions . The HPS trial result was not mediated through intention . Conclusions This study demonstrated that a theory-based process evaluation can provide useful information on causal mechanisms that aid not only interpretation of the trial but also inform future evaluations and intervention development Background Financial incentives have been used for many years internationally to improve quality of care in general practice . The aim of this pilot study was to determine if offering general practitioners ( GP ) a small incentive payment per test would increase  chlamydia testing in women aged 16 to 24 years , attending general practice . Methods General practice clinics ( n = 12 ) across Victoria , Australia , were cluster r and omized to receive either a $ AUD5 payment per chlamydia test or no payment for testing 16 to 24 year old women for chlamydia . Data were collected on the number of chlamydia tests and patient consultations undertaken by each GP over two time periods : 12 month pre-trial and 6 month trial period . The impact of the intervention was assessed using a mixed effects logistic regression model , accommodating for clustering at GP level . Results Testing increased from 6.2 % ( 95 % CI : 4.2 , 8.4 ) to 8.8 % ( 95 % CI : 4.8 , 13.0 ) ( p = 0.1 ) in the control group and from 11.5 % ( 95 % CI : 4.6 , 18.5 ) to 13.4 % ( 95 % CI : 9.5 , 17.5 ) ( p = 0.4 ) in the intervention group . Overall , the intervention did not result in a significant increase in chlamydia testing in general practice . The odds ratio for an increase in testing in the intervention group compared to the control group was 0.9 ( 95 % CI : 0.6 , 1.2 ) . Major barriers to increased chlamydia testing reported by GPs included a lack of time , difficulty in remembering to offer testing and a lack of patient awareness around testing . Conclusions A small financial incentive alone did not increase chlamydia testing  among young women attending general practice . It is possible small incentive payments in conjunction with reminder and feedback systems may be effective , as may higher financial incentive payments . Further research is required to determine if financial incentives can increase testing in Australian general practice , the type and level of financial scheme required and whether incentives needs to be part of a multi-faceted package . Trial Registration Australian New Zeal and Clinical Trial Registry ACTRN12608000499381 Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan . The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention , the MEND ( Mind Exercise Nutrition Do It ! ) program that is delivered to parents of children aged 2 - 4 years . Methods / Design This r and omised controlled trial will be conducted with 200 parents and their 2 - 4 year old children who attend the MEND 2 - 4 program in metropolitan and regional Victoria . Parent-child dyads will attend ten 90-minute group workshops . These workshops focus on general nutrition , as well as physical activity and behaviours . They are typically held at community or maternal and child health centres and run by a MEND 2 - 4 trained program leader . Child eating habits , physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline , the end of the intervention , and at 6 and 12 months post the intervention . Informed consent will be obtained from all parents , who will then be r and omly allocated to the intervention or wait-list control group . Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2 - 4 years . It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents , given that parental beliefs , attitudes , perceptions and behaviours appear to impact significantly on the development of early overweight . This is ' solution-oriented ' rather than ' problem-oriented ' research , with its focus being on prevention rather than intervention . If this is a positive trial , the MEND2 - 4 program can be implemented as a national program . Trial Registration Australian New Zeal and Clinical Trials Registry Background  Girl Scouting may offer a viable channel for health promotion and obesity prevention programs . This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was design ed to foster healthful troop meeting environments and increase obesity prevention behaviors at home . Methods Seven Girl Scout troops were r and omized to intervention ( n = 3 , with 34 girls ) or st and ard-care control ( n = 4 , with 42 girls ) conditions . Girls ranged in age from 9 to 13 years ( mean 10.5 years ) . Intervention troop leaders were trained to implement policies promoting physical activity ( PA ) and healthful eating opportunities at troop meetings , and to implement a curriculum promoting obesity-prevention behaviors at home . The primary outcome variable was child body mass index ( BMI ) z-score . Secondary outcomes included accelerometer-assessed PA levels in troop meetings , direct observations of snack offerings , time spent in physically active meeting content , and leader encouragement of PA and healthful eating . Results The intervention was delivered with good fidelity , and intervention troops provided greater opportunities for healthful eating and PA ( x2 = 210.8 , p < .001 ) , relative to control troops . In troop meetings , intervention troop leaders promoted  PA  ( x2 = 23.46 , p < .001 ) and healthful eating ( x2 = 18.14 , p < .001 ) more frequently , and discouraged healthful eating and PA less frequently ( x2 = 9.63 , p = .002 ) compared to control troop leaders . Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition , including the primary outcome of child BMI z-score ( F1 , 5 = 0.42 , p = .544 ) , parent BMI ( F1 , 5 = 1.58 , p = .264 ) , and related behavioral variables . The notable exception was for objective ly assessed troop PA , wherein girls in intervention troops accumulated significantly less sedentary ( x2 = 6.3 , p = .011 ) , significantly more moderate ( x2 = 8.2 , p = .004 ) , and more moderate-to-vigorous physical activity , ( x2 = 18.4 , p < .001 ) , than girls in control troops . Conclusions Implementing a health promotion curriculum and supporting policies to provide more healthful environments in Girl Scout troop meetings appears feasible on a broader scale . Additional work is needed to bridge health promotion from such setting s to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes . Trial registration number : Background Considering the high burden of disease of psychosocial problems in children and adolescents , early intervention regarding problem behaviour of young children is very important . The Preventive Child Healthcare ( PCH ) offers a good setting to detect such problem behaviour and to provide parenting support to the parents concerned . This paper aims to describe the design of an effectiveness study of a parenting programme for parents of children with mild psychosocial problems after an initial , evidence based screening in routine PCH . Methods / Design The effects of the intervention will be studied in a r and omised controlled trial . Prior to a routine PCH health examination , parents complete a screening question naire on psychosocial problems . Parents of children with increased but still sub clinical levels of psychosocial problems will be assigned at r and om to the experimental group ( Triple P , level 3 ) or to the control group ( care as usual ) . Outcome measures , such as problem behaviour in the child and parenting behaviour , will be assessed before , directly after and 6 and 12 months after the intervention . Discussion Parenting support may be an effective intervention to reduce psychosocial problems in children but evidence -based parenting programmes that fit the needs of the PCH are not available as yet . Although the Triple P programme seems promising and suitable for a universal population approach , evidence on its effectiveness in routine PCH still lacks . Trial registration Background Survivors of transient ischemic attack ( TIA ) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk . However , vascular risk factors , especially hypertension and high cholesterol , are not managed optimally even in those patients seen in specialized clinics . This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes . In this study , we will be testing a pharmacist case manager for delivery of stroke prevention services . We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes . Methods We will conduct a prospect i ve , r and omized , controlled open-label with blinded ascertainment of outcomes ( PROBE ) trial . Treatment allocation will be concealed from the study personnel , and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient 's clinical care or trial participation and who are masked to baseline measurements . Patients will be  r and omized to control or a pharmacist case manager treating vascular risk factors to guideline -recommended target levels . Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton , Alberta after an ischemic stroke or TIA who have uncontrolled hypertension ( defined as systolic blood pressure ( BP ) > 140 mm Hg ) or dyslipidemia ( fasting LDL-cholesterol > 2.00 mmol/L ) and who are not cognitively impaired or institutionalized . The primary outcome will be the proportion of subjects who attain ' optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L ) at six months compared to baseline ; 12-month data will also be collected for analyses of sustainability of any effects . A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected . Conclusions Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year . If our intervention improves the provision of secondary prevention therapies in these patients , the clinical ( and financial ) implication s will be enormous Background The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure . Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure . There is no single intervention to improve adherence with antihypertensives that is consistently effective . Community pharmacists are in an ideal position to promote adherence to chronic medications . This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy ( HAPPY ) . Methods / Design The HAPPY trial is a multi-centre prospect i ve r and omised controlled trial . Fifty-six pharmacies have been recruited from three Australian states . To identify potential patients , a software application ( MedeMine CVD ) extracted data from a community pharmacy dispensing software system ( FRED Dispense ® ) . The pharmacies have been r and omised to either ' Pharmacist Care Group ' ( PCG ) or ' Usual Care Group ' ( UCG ) . To check for ' Hawthorne effect ' in the UCG , a third group of patients ' Hidden Control Group ' ( HCG ) will be identified in the UCG pharmacies , which will be made known to the pharmacists at the end of six months . Each study group requires 182 patients . Data will be collected at baseline , three and six months in the PCG and at baseline and six months in the UCG . Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score , the Tool for Adherence Behaviour Screening and medication refill data . Discussion To our knowledge , this is the first research testing a comprehensive package of evidence -based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications . The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service , control for the ' Hawthorne effect ' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG , a strategy that is expected to improve retention . Trial Registration Australian New Zeal and Clinical Trial Registry Background This qualitative evaluation follows a r and omized-control trial of a  patient activation intervention  in which hypertensive patients received a letter in the mail asking them to discuss thiazide diuretics with their provider . Results of the parent study indicated that the intervention was effective at facilitating discussion s between patients and providers and enhancing thiazide prescribing rates . In the research presented here , our objective was to interview patients to determine their receptivity to patient activation , a potential leverage point for implementing interventions . Methods Semi-structured phone interviews were conducted with 54 patients , purpose fully sample d from a r and omized controlled trial of a patient activation intervention . All subjects had a history of hypertension and received primary care from one of twelve Veterans Affairs primary care clinics . All interviews were transcribed verbatim and review ed by the interviewer . Interviews were independently coded by three qualitative research ers until consensus was attained , and relevant themes and responses were identified , grouped , and compared . NVivo 8.0 was used for data management and analysis . Results Data from this qualitative study revealed that most participants held favorable opinions toward the patient activation intervention used in the clinical trial . Most ( 82 % ) stated they had a positive reaction . Patients emphasized they liked the intervention because it was straightforward and encouraged them to initiate discussion s with their provider . Also , by being active participants in their healthcare , patients felt more invested . Of the few patients offering negative feedback ( 11 % ) , their main concern was discomfort with possibly challenging their providers ' healthcare practice s. Another outcome of interest was the patients ' perceptions of why they were or were not prescribed a thiazide diuretic , for which several clinical ly relevant reasons were provided . Conclusion Patients ' perceptions of the intervention indicated it was effective via the encouragement of dialogue between themselves and their provider regarding evidence -based treatment options for hypertension . Additionally , patients ' experiences with thiazide prescribing discussion s shed light on the facilitators and barriers to implementing clinical practice guidelines regarding thiazides as first-line therapy for hypertension . Trial registration National Clinical Trial Registry number Background Rewarding provider performance has been recommended by the Institute of Medicine as an approach to improve the quality of treatment , yet little empirical research currently exists that has examined the effectiveness and cost-effectiveness of such approaches . The aim of this study is to test the effectiveness and cost-effectiveness of providing monetary incentives directly to therapists as a method to improve substance abuse treatment service delivery and subsequent client treatment outcomes . Design Using a cluster r and omized design , substance abuse treatment therapists from across 29 sites were assigned by site to either an implementation as usual ( IAU ) or pay-for-performance ( P4P ) condition . Participants Substance abuse treatment therapists participating in a large dissemination and implementation initiative funded by the Center for Substance Abuse Treatment . InterventionTherapists in both conditions received comprehensive training and ongoing monitoring , coaching , and feedback . However , those in the P4P condition also were given the opportunity to earn monetary incentives for achieving two sets of measurable behaviors related to quality implementation of the treatment . Outcomes Effectiveness outcomes will focus on the impact of the monetary incentives to increase the proportion of adolescents who receive a targeted threshold level of treatment , months that therapists demonstrate monthly competency , and adolescents who are in recovery following treatment . Similarly , cost-effectiveness outcomes will focus on cost per adolescent receiving targeted threshold level of treatment , cost per month of demonstrated competence , and cost per adolescent in recovery . Trial Registration Trial Registration Number : Background A complete description of the intervention in a published trial report is necessary for readers to be able to use the intervention , yet the completeness of intervention descriptions in trials is very poor . Low awareness of the issue by authors , review ers , and editors is part of the cause and providing specific instructions about intervention reporting to authors and encouraging full sharing of intervention material s is important . We assessed the extent to which : 1 ) journals ’ Instructions to Authors provide instructions about how interventions that have been evaluated in a r and omised controlled trial ( RCT ) should be reported in the paper ; and 2 ) journals offer the option of authors providing online supplementary material s. Methods We examined the web-based Instructions to  Authors  of  106 journals ( the six leading general medical journals , 50 r and omly selected journals from the National Library of Medicine ’s Core Clinical Journals , and 50 r and omly selected journals from the remainder of the journal collection indexed by PubMed ) . To be eligible , each journal must have published at least one r and omised trial involving human participants each year from 2008 to 2012 . We extracted all information related to the reporting of interventions , reporting of r and omised trials in general , and online supplementary material s. Results Of the 106 journals ’ Instructions to Authors , only 15 ( 14 % ) specifically mentioned the reporting of interventions and most of these provided non-specific advice such as ‘ describe essential features ’ . Just over half ( 62 , 58 % ) of the journals mentioned the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement in their author instructions . Seventy-eight ( 74 % ) of the journals ’ instructions mentioned the option of providing supplementary content online as part of the paper ; however , only four of these journals explicitly encouraged or m and ated use of this option for providing intervention information or material s. Conclusions Most journals ’ Instructions to Authors do not provide any specific instructions regarding reporting of interventions or encourage authors to provide online supplementary material s to enhance intervention reporting . Journals can help to improve the problem of incomplete intervention reporting by providing specific instructions to authors and peer review ers about intervention reporting and requiring full intervention descriptions to be provided Background Acute respiratory illness ( ARI ) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zeal and ( NZ ) . Environmental tobacco smoke ( ETS ) from household smoking is a significant and preventable contributor to childhood ARI . This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zeal and . For the purpose of this paper ' Indigenous ' refers to Australia 's Aboriginal and Torres Strait Isl and er peoples when referring to Australian Indigenous population s. In New Zeal and , the term ' Indigenous ' refers to Māori . Methods / Design This study will be a parallel , r and omized , controlled trial . Participants will be Indigenous women and their infants , half of whom will be r and omly allocated to an ' intervention ' group  , who will receive the tobacco control program over three home visits in the first three months of the infant 's life and half to a control group receiving ' usual care ' ( i.e. they will not receive the tobacco control program ) . Indigenous health workers will deliver the intervention , the goal of which is to reduce or eliminate infant exposure to ETS . Data collection will occur at baseline ( shortly after birth ) and when the infant is four months and one year of age . The primary outcome is a doctor-diagnosed , documented case of respiratory illness in participating infants . Discussion Interventions aim ed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities . There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children 's exposure to ETS among Indigenous population s. This study will provide high- quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness . Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zeal and and prevention of respiratory illness in children . Trial registration Australian New Zeal and Clinical Trials Registry ( ACTRN12609000937213 Background Despite access to various pharmacotherapies and counseling support to aid cessation , smokers typically demonstrate quit rates below 50 % . This report describes the results of a Phase 2a study exploring the efficacy of a liquid nicotine delivery system as an aid to smoking cessation assessed after 12 weeks of therapy . Methods A single-arm Phase 2a study was conducted . Community-based smokers ( ages 18 + years , smoking at least 10 cigarettes daily for the past year and interested in making a quit attempt ) were recruited and completed clinic visits at 2 week intervals over the 12 week study period where carbon monoxide levels were assessed and the Smoke-Break product was rated on taste and overall satisfaction . Participants were provided with a supply of liquid nicotine cigarettes ( e.g. , Smoke-Break ) at each clinic visit . A total of 69 smokers were enrolled and received the intervention product ( intention to treat group , ITT ) and 52 smokers verified participation ( according to protocol group , ATP ) . Results The cessation rate at 12 weeks after the baseline visit , assessed as the bioverified point prevalence of abstinence , was 71.1 % ( 95 % confidence interval [ CI ] 58.8%-83.5 % ) in the ATP group and 53.6 % ( 41.8%-65.4 % ) in the ITT group . Participants rated the liquid nicotine delivery system highly and also expressed general satisfaction . Few adverse events were identified with no serious adverse events . Conclusions These results support the efficacy of the liquid nicotine delivery system in smoking cessation . If this nicotine delivery product proves to be effective in larger trials , it could represent an inexpensive , readily accessible and well-tolerated agent to promote smoking cessation . Trial Registration This trial is registered at clinical trials.gov as study NCT00715871 Background Methamphetamine use is associated with HIV acquisition and transmission among men who have sex with men ( MSM ) .  Contingency management ( CM ) , providing positive reinforcement for drug abstinence and withholding reinforcement when abstinence is not demonstrated , may facilitate reduced methamphetamine use and sexual risk . We compared CM as a st and -alone intervention to a minimal intervention control to assess the feasibility of conducting a larger , more definitive trial of CM ; to define the frequency of behavioral outcomes to power such a trial ; and , to compute preliminary estimates of CM 's effectiveness . Methods We r and omly assigned 127 MSM from Seattle , WA who use methamphetamine to receive a 12-week CM intervention ( n = 70 ) or referral to community re sources ( n = 57 ) . Results Retention at 24 weeks was 84 % . Comparing consecutive study visits , non-concordant UAI declined significantly in both study arms . During the intervention , CM and control participants were comparably likely to provide urine sample s containing methamphetamine ( adjusted relative risk [ aRR ] = 1.09 ; 95%CI : 0.71 , 1.56 ) and to report non-concordant UAI ( aRR = 0.80 ; 95%CI : 0.47 , 1.35 ) . However , during post-intervention follow-up , CM participants were somewhat more likely to provide urine sample s containing methamphetamine than control participants ( aRR = 1.21 ; 95%CI : 0.95 , 1.54 , P = 0.11 ) . Compared to control participants , CM participants were significantly more likely to report weekly or more frequent methamphetamine use and use of more than eight quarters of methamphetamine during the intervention and post-intervention periods . Conclusions While it is possible to enroll and retain MSM who use methamphetamine in a trial of  CM  conducted outside drug treatment , our data suggest that CM is not likely to have a large , sustained effect on methamphetamine use . Trial Registration Clinical Trials.gov Identifier Background Type 2 diabetes is a major public health problem in Australia with prevalence increasing in parallel with increasing obesity . Prevention is an essential component of strategies to reduce the diabetes burden . There is strong and consistent evidence from r and omised controlled trials that type 2 diabetes can be prevented or delayed through lifestyle modification which improves diet , increases physical activity and achieves weight loss in at risk people . The current challenge is to translate this evidence into routine community setting s , determine feasible and effective ways of delivering the intervention and providing on-going support to sustain successful behavioural changes . Methods / Design The Sydney Diabetes Prevention Program ( SDPP ) is a translational study which will be conducted in 1,550 participants aged 50 - 65 years ( including 100 indigenous people aged 18 years and older ) at high risk of future development of diabetes . Participants will be identified through a screening and recruitment program delivered through primary care and will be offered a community-based lifestyle modification intervention . The intervention comprises an initial individual session and three group sessions based on behaviour change principles and focuses on five goals : 5 % weight loss , 210 min/week physical activity ( aerobic and strength training exercise ) , limit dietary fat and saturated fat to less than 30 % and 10 % of energy intake respectively , and at least 15 g/1000 kcal dietary fibre . This is followed by 3-monthly contact with participants to review progress and offer ongoing lifestyle advice for 12 months . The effectiveness and costs of the program on diabetes-related risk factors will be evaluated . Main outcomes include changes in weight , physical activity , and dietary changes ( fat , saturated fat and fibre intake ) . Secondary outcomes include changes in waist circumference , fasting plasma glucose , blood pressure , lipids , quality of life , psychological well being , medication use and health service utilization . Discussion This translational study will ascertain the reach , feasibility , effectiveness and cost-effectiveness of a lifestyle modification program delivered in a community setting through primary health care . If demonstrated to be effective , it will result in recommendations for policy change and practical methods for a wider community program for preventing or delaying the onset of type 2 diabetes in high risk people Background Dentists are in a unique position to advise smokers to quit by providing effective counseling on the various aspects of tobacco-induced diseases . The present study assessed the feasibility and acceptability of integrating dentists in a medical smoking cessation intervention . Methods Smokers willing to quit underwent an 8-week smoking cessation intervention combining individual-based counseling and nicotine replacement therapy and /or bupropion , provided by a general internist . In addition , a dentist performed a dental exam , followed by an oral hygiene treatment and gave information about chronic effects of smoking on oral health . Outcomes were acceptability , global satisfaction of the dentist 's intervention , and smoking abstinence at 6-month . Results 39 adult smokers were included , and 27 ( 69 % ) completed the study .  Global acceptability of the dental intervention was very high ( 94 % yes , 6 % mostly yes ) . Annoyances at the dental exam were described as acceptable by participants ( 61 % yes , 23 % mostly yes , 6 % , mostly no , 10 % no ) . Participants provided very positive qualitative comments about the dentist counseling , the oral exam , and the result ing motivational effect , emphasizing the feeling of oral cleanliness and health that encouraged smoking abstinence . At the end of the intervention ( week 8) , 17 ( 44 % ) participants reported smoking abstinence . After 6 months , 6 ( 15 % , 95 % CI 3.5 to 27.2 ) reported a confirmed continuous smoking abstinence . Discussion We explored a new multi-disciplinary approach to smoking cessation , which included medical and dental interventions . Despite the small sample size and non-controlled study design , the observed rate was similar to that found in st and ard medical care . In terms of acceptability and feasibility , our results support further investigations in this field . Trial Registration numberIS RCT In recalling a set of previously experienced events , people exhibit striking effects of recency , contiguity , and similarity : Recent items tend to be recalled best and first , and items that were studied in neighboring positions or that are similar to one another in some other way tend to evoke one another during recall . Effects of recency and contiguity have most often been investigated in tasks that require people to recall r and om word lists . Similarity effects have most often been studied in tasks that require people to recall categorized word lists . Here we examine recency and contiguity effects in lists composed of items drawn from 3 distinct taxonomic categories and in which items from a given category are temporally separated from one another by items from other categories , all of which are tested for recall . We find evidence for long-term recency and for long-range contiguity , bolstering support for temporally sensitive models of memory and highlighting the importance of underst and ing the interaction between temporal and semantic information during memory search Background In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objective ly measured physical activity among adults at risk of Type 2 diabetes . We aim ed to illuminate these findings by assessing whether the intervention program changed cognitions about increasing activity , defined by the Theory of Planned Behaviour , in ways consistent with the theory . Methods N = 365 sedentary participants aged 30–50 years with a parental history of Type 2 diabetes were r and omised to brief advice alone or to brief advice plus the intervention program delivered face-to-face or by telephone . Question naires at baseline , 6 and 12 months assessed cognitions about becoming more physically active . Analysis of covariance was used to test intervention impact . Bootstrapping was used to test multiple mediation of intervention impact . Results At 6 months , combined intervention groups ( face-to-face and telephone ) reported that they found increasing activity more enjoyable ( affective attitude , d = .25 ) , and they perceived more instrumental benefits ( e.g. , improving health ) ( d = .23 ) and more control ( d = .32 ) over increasing activity than participants receiving brief advice alone . Stronger intentions ( d = .50 ) in the intervention groups than the brief advice group at 6 months were partially explained by affective attitude and perceived control . At 12 months , intervention groups perceived more positive instrumental ( d = .21 ) and affective benefits ( d = .29 ) than brief advice participants . The intervention did not change perceived social pressure to increase activity . Conclusion Lack of effect of the intervention program on physical activity over and above brief advice was consistent with limited and mostly small short-term effects on cognitions . Targeting affective benefits ( e.g. , enjoyment , social interaction ) and addressing barriers to physical activity may strengthen intentions , but stronger intentions did not result in more behaviour change . More powerful interventions which induce large changes in TPB cognitions may be needed . Other interventions deserving further evaluation include theory-based brief advice , intensive measurement of physical and psychological factors , and monitoring of physical activity . Future research should consider a wider range of mediators of physical activity change , assess participants ' use of self-regulatory strategies taught in the intervention , and conduct experimental studies or statistical modelling prior to trial evaluation . IS RCT N61323766 Background Implementation of long-term condition management interventions rests on the notion of whole systems re- design , where incorporating wider elements of health care systems are integral to embedding effective and integrated solutions . However , most  self-management support ( SMS )  evaluations still focus on particular elements or outcomes of a sub-system . A r and omised controlled trial of a SMS intervention ( WISE — Whole System Informing Self-management Engagement ) implemented in primary care showed no effect on patient-level outcomes . This paper reports on a parallel process evaluation to ascertain influences affecting WISE implementation at patient , clinical and organisational levels . Normalisation Process Theory ( NPT ) provided a sensitising background and analytical framework . Methods A multi- method approach using surveys and interviews with organisational stakeholders , practice staff and trial participants about impact of training and use of tools developed for WISE . Analysis was sensitised by NPT ( coherence , cognitive participation , collective action and reflective monitoring ) . The aim was to identify what worked and what did not work for who and in what context . Results Interviews with organisation stakeholders emphasised top-down initiation of WISE by managers who supported innovation in self-management . Staff from 31 practice s indicated engagement with training but patchy adoption of WISE tools ; SMS was neither prioritised by practice s nor fitted with a biomedically focussed ethos , so little effort was invested in WISE techniques . Interviews with 24 patients indicated no awareness of any changes following the training of practice staff ; furthermore , they did not view primary care as an appropriate place for SMS . Conclusion The results contribute to underst and ing why SMS is not routinely adopted and implemented in primary care . WISE was not embedded because of the perceived lack of relevance and fit to the ethos and existing work . Enacting SMS within primary care practice was not viewed as a legitimate activity or a professional priority . There was failure to , in principle , engage with and identify patients ' support needs . Policy presumptions concerning SMS appear to be misplaced . Implementation of SMS within the health service does not currently account for patient circumstances . Primary care priorities and support for SMS could be enhanced if they link to patients ' broader systems of implementation networks and re sources Background Because parental recognition of overweight in young children is poor , we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change . This study will assess 1 ) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child 's weight status and enhances motivation for behaviour change , and 2 ) whether a family-based individualised lifestyle intervention , delivered primarily by a MInT mentor with limited support from " expert " consultants in psychology , nutrition and physical activity , can improve weight outcomes after 12 and 24 months in young overweight children , compared with usual care . Methods / Design 1500 children aged 4 - 8 years will be screened for overweight ( height , weight , waist , blood pressure , body composition ) . Parents will complete question naires on feeding practice s , physical activity , diet , parenting , motivation for healthy lifestyles , and demographics . Parents of children classified as overweight ( BMI ≥ CDC 85th ) will receive feedback about the results using Motivational interviewing or Usual care . Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention . Additional baseline measurements ( accelerometry , diet , quality of life , child behaviour ) will be collected and families will be r and omised to Tailored package or Usual care . Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity . Parents in the Tailored package condition will attend a single session with an " expert team " ( MInT mentor , dietitian , physical activity advisor , clinical psychologist ) to identify current challenges for the family , develop tailored goals for change , and plan behavioural strategies that best suit each family . The mentor will continue to provide support to the family via telephone and in-person consultations , decreasing in frequency over the two-year intervention . Outcome measures will be obtained at baseline , 12 and 24 months . Discussion This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child 's weight status and to assess the efficacy of a supportive , individualised early intervention to improve weight outcomes in young children . Trial registration Australian New Zeal and Clinical Trials Registry Background This study aim ed to evaluate the impact of a primary prevention intervention program on risk behavior for allergic diseases among children up to 2 years of age . The setting was in ordinary pre- and postnatal primary health care in Trondheim , Norway . Methods The Prevention of Allergy among Children in Trondheim , Norway ( PACT ) study invited all pregnant women and parents to children up to 2 years of age in the community to participate in a non-r and omized , controlled , multiple life-style intervention study . Interventional topics was increased dietary intake of cod liver oil and oily fish for women during pregnancy and for infants during the first 2 years of life , reduced parental smoking and reduced indoor dampness . A control cohort was established prior to the intervention cohort with " follow up as usual " . Question naires were completed in pregnancy , 6 weeks after birth and at 1 and 2 years of age . Trends in exposure and behavior are described . Results Intake of oily fish and cod liver oil  increased statistically significantly among women and infants in the intervention cohort compared to the control cohort . There was a low postnatal smoking prevalence in both cohorts , with a trend towards a decreasing smoking prevalence in the control cohort . There was no change in indoor dampness or in behavior related to non- intervened life-style factors . Conclusions The dietary intervention seemed to be successful . The observed reduced smoking behavior could not be attributed to the intervention program , and the latter had no effect on indoor dampness . Trial registration s(Current Controlled Trials registration number : IS RCT N28090297 Background Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease . Despite this , a substantial proportion of children in developed nations , including Australia , do not consume sufficient quantities of fruits and vegetables . Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children . The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children . Methods / Design The study , conducted in the Hunter region of New South Wales , Australia , employs a cluster r and omised controlled trial design . Two hundred parents from 15 r and omly selected preschools will be r and omised to receive the intervention , which consists of print re sources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers . The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home , create supportive family eating routines and role-model fruit and vegetable consumption . A further two hundred parents will be r and omly allocated to the control group and will receive printed nutrition information only . The primary outcome of the trial will be the change in the child 's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children 's Dietary Question naire . Pre-intervention and post-intervention parent surveys will be administered over the telephone . Baseline surveys will occur one to two weeks prior to intervention delivery , with follow-up data collection calls occurring two , six , 12 and 18 months following baseline data collection . Discussion If effective , this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in childhood and reduce the risk of subsequent chronic disease . Trial registration Australian Clinical Trials Registry Background R and omized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment . Employers can now purchase depression products that provide depression care management , defined as employee screening , education , monitoring , and clinician feedback for all depressed employees . We developed an intervention to encourage employers to purchase a depression product that offers the type , intensity , and duration of care management shown to improve clinical and work outcomes . Methods In a r and omized controlled trial conducted with 360 employers of 30 regional business coalitions , the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products . The study will also identify mediators and organizational-level moderators of intervention impact . Employers r and omized to the  value-based  condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer . Employers r and omized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators  for outpatient depression treatment . Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing , depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted . Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages . The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data . Discussion By addressing the ' value to whom ? ' question , the study advances knowledge about one of the most pivotal problems in the translation of evidence -based care to ' real world ' setting s : whether purchasers can be influenced to buy healthcare products on the basis of value and not exclusively on the basis of cost . If value-based marketing increases depression product purchase rates over usual care , this study will provide encouragement to market new healthcare products on the basis of the product 's value to the purchaser as well as the recipient of care . Trial Registration Clinical Trials Registration Number : Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care . A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines . Further , the review recommended the use of theory in the development of implementation interventions . A clinical practice guideline for the management of acute low-back pain has been developed in Australia ( 2003 ) . Acute low-back pain is a common condition , has a high burden , and there is some indication of an evidence - practice gap in the allied health setting . This provides an opportunity to develop and test a theory-based implementation intervention which , if effective , may provide benefits for patients with this condition . Aims This study aims to estimate the effectiveness of a theory-based intervention  to increase allied health practitioners ' ( physiotherapists and chiropractors in Victoria , Australia ) compliance with a clinical practice guideline for acute non-specific low back pain ( LBP ) , compared with providing practitioners with a printed copy of the guideline . Specifically , our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray  , and improving mean level of disability for patients three months post-onset of acute LBP . Methods The design of the study is a cluster r and omised trial . Restricted r and omisation was used to r and omise 210 practice s ( clusters ) to an intervention or control group . Practitioners in the control group received a printed copy of the guideline . Practitioners in the intervention group received a theory-based intervention developed to address prospect ively identified barriers to practitioner compliance with the guideline . The intervention primarily consisted of an educational symposium .  Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period , three months post the intervention symposia , are eligible for inclusion . Sample size calculations are based on recruiting between 15 to 40 patients per practice . Outcome assessors will be blinded to group allocation . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12609001022257 ( date registered 25th November 2009 This article reports the development and exploratory testing of a school-based intervention programme design ed to enhance levels of physical activity in adolescents . The intervention is based on social cognitive theory ( SCT ) , self-regulation theory ( SRT ) and planning as evidence -based mediators of physical activity changes . Two classes , paired on socio-economic variables , were selected from each of eight Portuguese schools and r and omly assigned to an  intervention or control group ( N = 291 ) . Primary outcome was ‘ moderate to vigorous physical activity ’ ( International Physical Activity Question naire ) measured pre and post intervention and at three and nine months follow-up . SCT , SRT and planning variables were secondary outcomes measured pre and post intervention . At post test , participants in the intervention group reported 18 min per week more physical activity ( PA ) , adjusted for pre-intervention , age and sex , than those in the control group ( 95 % confidence interval −10 to 46 ; p = 0.249 ) . This difference increased to 33 min ( 95 % CI–4 to 71 ; p = 0.082 ) at three months and to 57 min ( 95 % CI 13 to 101 , p = 0.008 ) at nine month follow-up . Moreover , the intervention result ed in changes of some of the theoretical target variables , including outcome expectancies and coping planning . However , no evidence was found for the changes in theoretical moderators to mediate the intervention effects on behaviour . Implication s for theory and for future research are discussed In this article two new methods for building and evaluating eHealth interventions are described . The first is the Multiphase Optimization Strategy ( MOST ) . It consists of a screening phase , in which intervention components are efficiently identified for inclusion in an intervention or for rejection , based on their performance ; a refining phase , in which the selected components are fine tuned and issues such as optimal levels of each component are investigated ; and a confirming phase , in which the optimized intervention , consisting of the selected components delivered at optimal levels , is evaluated in a st and ard r and omized controlled trial . The second is the Sequential Multiple Assignment R and omized Trial ( SMART ) , which is an innovative research design especially suited for building time-varying adaptive interventions . A SMART trial can be used to identify the best tailoring variables and decision rules for an adaptive intervention empirically . Both the MOST and SMART approaches use r and omized experimentation to enable valid inferences . When properly implemented , these approaches will lead to the development of more potent eHealth interventions Background Evidence generated from reliable research is not frequently implemented into clinical practice . Evidence -based clinical practice guidelines are a potential vehicle to achieve this . A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines . Recommendations from this review , and other studies , have suggested the use of interventions that are theoretically based because these may be more effective than those that are not . An evidence -based clinical practice guideline for the management of acute low back pain was recently developed in Australia . This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common , has a high burden , and for which there is an evidence - practice gap in the primary care setting . Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria , Australia . Specifically , our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray  , and improving mean level of disability for patients three months post-consultation . Methods / Design This study protocol describes the details of a cluster r and omised controlled trial . Ninety-two general practice s ( clusters ) , which include at least one consenting general practitioner , will be r and omised to an intervention or control arm using restricted r and omisation . Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion . An average of twenty-five patients per general practice will be recruited , providing a total of 2,300 patient participants . General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy . Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory . Investigators ( not involved in the delivery of the intervention ) , patients , outcome assessors and the study statistician will be blinded to group allocation . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN012606000098538 ( date registered 14/03/2006 )
BACKGROUND Meeting global health challenges requires effective behaviour change interventions ( BCIs ) .
This depends on advancing the science of behaviour change which , in turn , depends on accurate intervention reporting .
Current reporting often lacks detail , preventing accurate replication and implementation .
Recent developments have specified intervention content into behaviour change techniques ( BCTs ) - the ' active ingredients ' , for example goal - setting , self-monitoring of behaviour .
BCTs are ' the smallest components compatible with retaining the postulated active ingredients , i.e. the proposed mechanisms of change .
Domain-specific taxonomies of BCTs have been developed , for example healthy eating and physical activity , smoking cessation and alcohol consumption .
OBJECTIVE ( 1 ) To develop a method of specifying content of BCIs in terms of component BCTs ; ( 2 ) to lay a foundation for a comprehensive methodology applicable to different types of complex interventions ; ( 3 ) to develop re sources to support application of the taxonomy ; and ( 4 ) to achieve multidisciplinary and international acceptance for future development .