Rationale and study protocol for the 'eCoFit' randomized controlled trial: Integrating smartphone technology, social support and the outdoor physical environment to improve health-related fitness among adults at risk of, or diagnosed with, Type 2 Diabetes. Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care Effects of a home-based rehabilitation program in obese type 2 diabetics. [The PRECIS-2 tool: designing trials that are fit for purpose]. Physical activity levels six months after a randomised controlled physical activity intervention for Pakistani immigrant men living in Norway Aerobic physical activity and resistance training: an application of the theory of planned behavior among adults with type 2 diabetes in a random, national sample of Canadians A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Intervening to Reduce Sedentary Behaviors and Childhood Obesity among School-Age Youth: A Systematic Review of Randomized Trials How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: The Transform-Us! Study Steps that count! : The development of a pedometer-based health promotion intervention in an employed, health insured South African population Controlled outcome evaluation of the First Step Program: a daily physical activity intervention for individuals with type II diabetes The physical activity counselling (PAC) randomized controlled trial: rationale, methods, and interventions. Should implementation intentions interventions be implemented in obesity prevention: the impact of if-then plans on daily physical activity in Dutch adults Intervention Effects on Physical Activity and Insulin Levels in Men of Pakistani Origin Living in Oslo: A Randomised Controlled Trial Randomized controlled trial testing an internet physical activity intervention for sedentary adults. Correlates of preschool children’s objectively measured physical activity and sedentary behavior: a cross-sectional analysis of the SPLASHY study Development and evaluation of two web-based interventions for the promotion of physical activity in older adults: study protocol for a community-based controlled intervention trial Development of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: OncoActive Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Perceptions of Patients With Chronic Obstructive Pulmonary Disease and Their Physiotherapists Regarding the Use of an eHealth Intervention A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients.
INTRODUCTION The prevalence and risk of Type 2 Diabetes ( T2D ) has dramatically increased over the past decade . Physical activity ( PA ) has significant benefits for the treatment and prevention of T2D . The aim of this study is to develop , implement and evaluate a community-based PA intervention to improve aerobic and muscular fitness among adults at risk of , or diagnosed with T2D . RESEARCH DESIGN AND METHODS The eCoFit pilot intervention will be evaluated using a r and omized controlled trial ( RCT ) design . The 20-week ( Phases 1 and 2 ) multi-component intervention was guided by Social Cognitive Theory , Health Action Process Approach Model , and Cognitive Behavior Therapy strategies . Phase 1 ( Weeks 1 - 10 ) includes : i ) 5 group face-to-face sessions consisting of outdoor training and cognitive mentoring ; and ii ) the use of the eCoFit smartphone application with a description of where and how to use the outdoor environment to be more physically active . Phase 2 ( Weeks 11 - 20 ) includes the use of the eCoFit smartphone application only . Assessment s are to be conducted at baseline , 10-weeks ( primary end-point ) and 20-weeks ( secondary end-point ) post-baseline . Primary outcomes are cardio-respiratory fitness and muscular fitness ( lower body ) . Secondary outcomes include physical , behavioral , mental health and quality of life , and social-cognitive outcomes . DISCUSSION eCoFit is an innovative , multi-component intervention , which integrates smartphone technology , social support and the outdoor physical environment to promote aerobic and resistance training PA among adults at risk of , or diagnosed with T2D . The findings will be used to guide future interventions and to develop and implement effective community-based prevention programs . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry No : ACTRN12615000990527 Background Physical activity ( PA ) and nutrition are the cornerstones of diabetes management . Several review s and meta-analyses report that PA independently produces clinical ly important improvements in glucose control in people with Type 2 diabetes . However , it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care . Methods This study will determine whether an evidence -informed multifaceted behaviour change intervention ( Movement as Medicine for Type 2 Diabetes ) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting . An open pilot study conducted in two primary care practice s ( phase one ) will assess acceptability , feasibility and fidelity . Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures . A two-arm parallel group clustered pilot r and omised controlled trial with patients from participating primary care practice s in North East Engl and will assess acceptability , feasibility , and fidelity of the intervention ( versus usual clinical care ) and trial processes over a 12-month period . Consultation behaviour involving fidelity of intervention delivery , diabetes and PA related knowledge , attitudes/beliefs , intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals . We will rehearse the collection of outcome data ( with the focus on data yield and quality ) for a future definitive trial , through outcome assessment at baseline , one , six and twelve months . An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care . Discussion Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence -base , that is , the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes . The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents , to the best of our knowledge , the first of its kind in the United Kingdom . This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care . Trial registration Movement as Medicine for Type 2 Diabetes ( MaMT2D ) was registered with Current Controlled Trials on the 14th January 2012 : IS RCT N67997502 . The first primary care practice was r and omised on the 5th October 2012 OBJECTIVE To assess , in obese type 2 diabetics ( T2D ) , the impact of a home-based effort training program and the barriers to physical activity ( PA ) practice . METHOD Twenty-three obese T2D patients ( 52.7 ± 8.2 years , BMI = 38.5 ± 7.6 kg/m(2 ) ) were r and omized to either a control group ( CG ) , or an intervention group ( IG ) performing home-based cyclergometer training during 3 months , 30 min/day , with a monthly-supervised session . The initial and final measurements included : maximal grade d effort test on cyclergometer , 6-minute walk test ( 6MWT ) and 200-meter fast walk test ( 200mFWT ) , quadriceps maximal isometric strength , blood tests and quality of life assessment ( SF- 36 ) . A long-term assessment of the amount of physical activity ( PA ) and the barriers to PA practice was conducted using a question naire by phone call . RESULTS Patients in the CG significantly improved the maximal power developed at the peak of the cyclergometer effort test ( P < 0.05 ) as well as the quadriceps strength ( P < 0.01 ) . There were no significant changes in the other physical and biological parameters , neither in quality of life . At a mean distance of 17 ± 6.4 months , the PA score remained low in the two groups . The main barriers to PA practice identified in both groups were the perception of a low exercise capacity and a poor tolerance to effort , lack of motivation , and the existence of pain associated to PA . CONCLUSION This home-based intervention had a positive impact on biometrics and physical ability in the short term in obese T2D patients , but limited effects in the long term . The question naires completed at a distance suggest considering educational strategies to increase the motivation and compliance of these patients To evaluate the intervention effects of r and omized controlled trials ( RCT ) involved in theoretical efficacy and actual clinical outcome ( effectiveness ) . Pragmatic-Explanatory Continuum Indicator Summary ( PRECIS ) is a tool to help research ers make decisions in study design which is consistent with the intended purpose of their trial which can be used in the design of RCT to balance the internal validity and external validity . The role of PRECIS has been gradually recognized in the practice of design ing clinical trials . To ensure that the design choices are concordant with the intention and the facilitation of use set by patients , clinicians and policy makers , a new PRECIS-2 tool has been developed by mangy international team experts under modification and upgrading the existing PRECIS . The PRECIS-2 tool mainly focuses on trial design choices which determining the applicability of a trial . PRECIS-2 has nine domains , with each of them intends to help the research ers consider the consequences of that design decision in terms of the applicability of the results under particular setting . The purpose of this paper is to introduce the development , basic principle , characteristics and application of PRECIS-2 for the design ers and decision makers when working on clinical trials Background To our knowledge , no studies have aim ed at improving the PA level in south Asian immigrant men residing in Western countries , and few studies have considered the relevance of SCT constructs to the PA behaviour of this group in the long term . The observed low  physical activity ( PA ) level among south Asian immigrants in Western countries may partly explain the high prevalence of cardiovascular diseases ( CVD ) and type 2 diabetes ( T2D ) in this group . We have shown previously in a r and omised controlled trial , the Physical Activity and Minority Health study ( PAMH ) that a social cognitive based intervention can beneficially influence PA level and subsequently reduce waist circumference and insulin resistance in the short-term . In an extended follow-up of the PAMH study : we aim ed 1 ) to determine if the intervention produced long-term positive effects on PA level six months after intervention ( follow-up 2 ( FU2 ) ) , and 2 ) to identify the social cognitive mediators of any intervention effects . Methods Physically inactive Pakistani immigrant men ( n = 150 ) who were free of CVD and T2D were r and omly assigned to a five months PA intervention or a control group . Six months after the intervention ended , we telephoned all those who attended FU1 and invited them for a second follow-up test ( FU2 ) ( n = 133 ) . PA was measured using ActiGraph accelerometers . Statistical differences between groups were determined by use of ANCOVA . Results Significant differences ( baseline to FU2 ) between the groups were found for all PA variables ( e.g. , total PA level , sedentary time , PA intensity ) . Support from family and outcome expectancies increased more in the intervention group compared with the control group . Self-efficacy did not differ significantly between groups . Conclusions Our results show that a multi component PA programme can increase PA over the short and long term in a group of immigrant Pakistani men . However , we could not identify the factors that mediated these changes in PA . Protocol ID07112001326 , NCT ID : Background Aerobic physical activity ( PA ) and resistance training are paramount in the treatment and management of type 2 diabetes ( T2D ) , but few studies have examined the determinants of both types of exercise in the same sample . Objective The primary purpose was to investigate the utility of the Theory of Planned Behavior ( TPB ) in explaining aerobic PA and resistance training in a population sample of T2D adults . Methods A total of 244 individuals were recruited through a r and om national sample which was created by generating a r and om list of household phone numbers . The list was proportionate to the actual number of household telephone numbers for each Canadian province ( with the exception of Quebec ) . These individuals completed self-report TPB constructs of attitude , subjective norm , perceived behavioral control and intention , and a 3-month follow-up that assessed aerobic PA and resistance training . Results TPB explained 10 % and 8 % of the variance respectively for aerobic PA  and resistance training ;  and accounted for 39 % and 45 % of the variance respectively for aerobic PA and resistance training intentions . Conclusion These results may guide the development of appropriate PA interventions for aerobic PA and resistance training based on the TPB OBJECTIVE To propose a tool to assist trialists in making design decisions that are consistent with their trial 's stated purpose . STUDY DESIGN AND SETTING R and omized trials have been broadly categorized as either having a pragmatic or explanatory attitude . Pragmatic trials seek to answer the question , " Does this intervention work under usual conditions ? , " whereas explanatory trials are focused on the question , " Can this intervention work under ideal conditions ? " Design decisions make a trial more ( or less ) pragmatic or explanatory , but no tool currently exists to help research ers make the best decisions possible in accordance with their trial 's primary goal . During the course of two international meetings , participants with experience in clinical care , research commissioning , health care financing , trial methodology , and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory . RESULTS We have developed a tool ( called PRECIS ) with 10 key domains and which identifies criteria to help research ers determine how pragmatic or explanatory their trial is . The assessment is summarized graphically . CONCLUSION We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial Objective . To assess the effectiveness of interventions that focus on reducing  sedentary behavior ( SB ) among school-age youth and to identify elements associated with interventions ' potential for translation into practice setting s. Methods . A comprehensive literature search was conducted using 4 data bases for peer- review ed studies published between 1980 and April 2011 . R and omized trials , which lasted at least 12 weeks , aim ed at decreasing  SB among children aged 6 to 19 years were identified . Results . Twelve studies were included ; 3 focused only on SB , 1 focused on  physical activity ( PA )  , 6 were combined SB and PA interventions , and 2 studies targeted SB , PA , and diet .  The majority of the studies were conducted in a school setting , while others were conducted in such setting s as clinics , community centers , and libraries . Conclusions . Overall , interventions that focused on decreasing SB were associated with reduction in time spent on SB and /or improvements in anthropometric measurements related to childhood obesity . Several of the studies did consider elements related to the intervention 's potential for translation into practice setting Background Numerous explanatory r and omized trials support the efficacy of chronic disease interventions , including smoking cessation treatments . However , there is often inadequate adoption of these interventions for various reasons , one being the limitation of generalizability of the explanatory studies in real-world setting s. R and omized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions . Pragmatic r and omized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health re source allocation decisions . However , there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study . Methods We design ed a  pragmatic , r and omized , controlled study to maximize external validity by addressing several barriers to  smoking cessation therapy in ambulatory care . We analyzed our design and methods using the recently published ‘ Pragmatic – Explanatory Continuum Indicatory Summary ( PRECIS ) ’ tool , a qualitative method to assess trial design across 10 domains . We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains . Results After two rounds of review , there was consensus on all 10 domains of study design . No single domain was scored as either fully pragmatic or fully explanatory ; but overall , the study scored high on pragmatism . Conclusions This addition to the PRECIS tool may assist other trial design ers working with interdisciplinary co-investigators to rate their study design while building consensus Background Physical activity ( PA ) is associated with positive cardio-metabolic health and emerging evidence suggests sedentary behavior ( SB ) may be detrimental to children 's health independent of PA . The primary aim of the Transform-Us ! study is to determine whether an 18-month , behavioral and environmental intervention in the school and family setting s results in higher levels of PA and lower rates of SB among 8 - 9 year old children compared with usual practice ( post-intervention and 12-months follow-up ) . The secondary aims are to determine the independent and combined effects of PA and SB on  children 's cardio-metabolic health risk factors ; identify the factors that mediate the success of the intervention ; and determine whether the intervention is cost-effective . Methods / design A four-arm cluster-r and omized controlled trial ( RCT ) with a 2 × 2 factorial design , with schools as the unit of r and omization . Twenty schools will be allocated to one of four intervention groups , sedentary behavior ( SB-I ) , physical activity ( PA-I ) , combined SB and PA ( SB+PA-I ) or current practice control ( C ) , which will be evaluated among approximately 600 children aged 8 - 9 years in school year 3 living in Melbourne , Australia . All children in year 3 at intervention schools in 2010 ( 8 - 9 years ) will receive the intervention over an 18-month period with a maintenance ' booster ' delivered in 2012 and children at all schools will be invited to participate in the evaluation assessment s. To maximize the sample and to capture new students arriving at intervention and control schools , recruitment will be on-going up to the post-intervention time point . Primary outcomes are time spent sitting and in PA assessed via accelerometers and inclinometers and survey . Discussion To our knowledge , Transform-Us ! is the first RCT to examine the effectiveness of intervention strategies for reducing children 's overall sedentary time , promoting PA and optimizing health outcomes . The integration of consistent strategies and messages to children from teachers and parents in both school and family setting s is a critical component of this study , and if shown to be effective , may have a significant impact on educational policies as well as on pedagogical and parenting practice s . Trial registration ACTRN12609000715279 ; Current Controlled Trials IS RCT Background  Physical activity ( PA )  has been identified as a central component in the promotion of health . PA programs can provide a low cost intervention opportunity , encouraging PA behavioral change while worksites have been shown to be an appropriate setting for implementing such health promotion programs . Along with these trends , there has been an emergence of the use of pedometers as a self-monitoring and motivational aid for PA.This study determines the effectiveness of a worksite health promotion program comprising of a 10-week , pedometer-based intervention ( “ Steps that Count ! ” ) , and individualized email-based feedback to effect PA behavioral change . Methods The study is a r and omized controlled trial in a worksite setting , using pedometers and individualized email-based feedback to increase steps per day ( steps/d ) .  Participant selection will be based on attendance at a corporate wellness event and information obtained , following the completion of a Health Risk Appraisal ( HRA ) , in keeping with inclusion criteria for the study . All participants will , at week 1 ( pre-intervention ) , be provided with a blinded pedometer to assess baseline levels of PA . Participants will be provided with feedback on pedometer data and identify strategies to improve daily PA towards current PA recommendations . Participants will thereafter be r and omly assigned to the intervention group ( INT ) or control group ( CTL ) . The INT will subsequently wear an un-blinded pedometer for 10 consecutive weeks . Individualized feedback messages based on average steps per day , derived from pedometer data ( INT ) and general supportive/motivational messages ( INT+CTL ) , will be provided via bi-weekly e-mails ; blinded pedometer-wear will be conducted at week 12 ( post-intervention : INT+CTL ) . Discussion The purpose of this paper is to outline the rationale behind , and the development of , an intervention aim ed at improving ambulatory PA through pedometer use , combined with regular , individualized , email-based feedback . Pedometer-measured PA and individualized feedback may be a practical and easily applied intervention . Trial registration Number : DOH-27 - 0112 - OBJECTIVE : To conduct a r and omised trial of a physical activity ( PA ) intervention , The First Step Program ( FSP ) for adults with type II diabetes . DESIGN : A 16-week intervention study and 24-week follow-up assessment . PARTICIPANTS : A total of 47 overweight/obese , sedentary individuals ( age=52.7±5.2 y ; BMI = 33.3±5.6 kg/m2 ) recruited through a diabetes education centre . MEASUREMENTS : Primary outcome :  daily PA assessed by pedometer ( steps/day ) . Secondary outcomes : anthropometric measures ( weight , BMI , waist girth , hip girth ) ; indicators of cardiovascular health ( resting heart rate and blood pressure ) ; glycemic control ( fasting glucose , insulin , HbA1c , glucose concentration 120 min postglucose load ) ; plasma lipid status ( total cholesterol , HDL cholesterol , LDL cholesterol , and triglycerides ) . RESULTS : Relative to the CONTROL group , FSP participants increased  their PA > 3000 steps/day ( approximately 30 min/day ) during the intervention ( P<0.0001 ) . Waist and hip girth decreased ( approximately 2–3 cm ) , but did not differ significantly between groups . Significant changes did not emerge for any of the other variables . CONCLUSIONS : The FSP is a practical intervention that elicits an immediate and profound change in walking behaviour . Such change is an important ‘ first step ’ towards increasing the volume and /or intensity of PA necessary to improve long-term health outcomes in this largely sedentary and overweight or obese population . Relapse by 24 weeks indicates that other strategies such as booster sessions are needed to maintain lifestyle change . Further research must determine realistic and responsive health outcomes for this population that are achievable through practical , real-world programming Primary care is a promising venue to build patient motivation and confidence to increase physical activity ( PA ) . Physician PA counselling has demonstrated some success ; however , maintenance of behaviour change appears to require more intensive interventions . In reality , most physicians do not have the necessary training nor the time for this type of counselling . The purpose of this paper is to outline the rationale , methods , and interventions for the ongoing physical activity counselling ( PAC ) r and omized controlled trial ( RCT ) , which aims to assess the impact of integrating a PA counsellor into a primary care practice . This RCT has 2 arms : ( i ) brief PA counselling ( 2 - 4 min ) from a health care provider and ( ii ) brief PA counselling+intensive PA counselling from a PA counsellor ( 3 months ) . The impact of this intervention is being evaluated using the comprehensive RE- AIM framework . One hundred twenty insufficiently active adult patients , aged 18 to 69 y and recruited during regular primary care visits have been r and omized . Dependent measures include psychological mediators , PA participation , quality of life , and physical and metabolic outcomes . The PAC project represents an innovative , theoretically-based approach to promoting PA in primary care , focusing on psychological mediators of change . We anticipate that key lessons from this study will be useful for shaping future public health interventions , theories , and research Background Forming implementation intentions ( specifying when , where and how to act ) has been proposed as a potentially effective and inexpensive intervention , but has mainly been studied in controlled setting s for straightforward behaviors . Purpose To examine if forming implementation intentions ( II ) could be used in large-scale , population -based interventions that aim to promote more complex and clinical ly relevant behavior change , we tested the impact of different II on increasing daily physical activity ( PA ) aim ed at weight maintenance among 709 Dutch adults . Methods At T0 , participants were r and omly allocated to a control group or to form II for 1 ) a prescribed action ( walking ) , 2 ) self-selected activities , 3 ) self-selected activities and repeat making these II two times . All participants were asked to increase PA  by at least two hours a week ( 15–20 minutes per day ) . Post-tests took place two weeks ( response 85 % ) , three months ( response 78 % ) and six months ( response 79 % ) post-intervention . Results No main effects of II formation on BMI or physical activity were found . Intention to increase physical activity moderated the effects of repeated II , but not of the other II conditions . Forming repeated II had a positive effect on total PA and number of active days for respondents with strong intentions . Conclusion Implementation intention interventions may not yet be ready for implementation on its own for large-scale obesity prevention in the general public . Future research should test strategies for optimal II formation in both initiating and maintaining behavioral change . Trial registration IS RCT High prevalence of type 2 diabetes ( T2D ) is seen in some immigrant groups in Western countries , particularly in those from the Indian subcontinent . Our aims were to increase the physical activity ( PA ) level  in a group of Pakistani immigrant men , and to see whether any increase was associated with reduced serum glucose and insulin concentrations . The intervention was developed in collaboration with the Pakistani community . It used a social cognitive theory framework and consisted of structured supervised group exercises , group lectures , individual counselling and telephone follow-up .  One- hundred and fifty physically inactive Pakistani immigrant men living in Oslo , Norway , were r and omised to either a control group or an intervention group . The 5-month intervention focused on increasing levels of PA  , which were assessed by use of accelerometer ( Actigraph MTI 7164 ) recordings . Risk of diabetes was assessed by serum glucose and insulin concentrations determined in a fasted state , and after an oral glucose tolerance test ( OGTT ) . ANCOVA was used to assess differences between groups . There was a mean difference in PA between the two groups of 49 counts per minute per day , representing a 15 % ( 95 % CI = 8.7–21.2 ; P = 0.01 ) higher increase in total PA level in the intervention group than in the control group . Insulin values taken 2 h after an OGTT were reduced in the intervention group by 27 % ( 95 % CI = 18.9–35.0 ; P = 0.02 ) more than those in the control group . There were no differences in fasting or postpr and ial glucose values between the groups at the follow-up test . This type of intervention can increase PA and reduce serum insulin in Pakistani immigrant men , thereby presumably reducing their risk of T2D OBJECTIVE Internet-based physical activity ( PA ) interventions have shown promise , although findings remain equivocal . We used formative research to enhance a previously demonstrated program ( Step into Motion ) with the goal of developing an Internet program poised for dissemination . METHODS We conducted focus groups to identify Internet features targeted to theoretical constructs ( social cognitive theory ) predictive of PA behavior and rated as " useful for increasing PA . " We identified 5 theory-targeted Internet features as useful for increasing PA : ( 1 ) a PA tracking/logging calendar targeting self-monitoring and goal setting ; ( 2 ) geographic mapping tools targeting perceived environment ; ( 3 ) a discussion forum targeting social support ; ( 4 ) exercise videos targeting observational learning ; and ( 5 ) regular up date s of peer PA progress targeting situation . We then tested the efficacy of the enhanced program ( enhanced Internet , EI ; N = 25 ) in relation to publicly available PA Websites ( st and ard Internet , SI ; N = 28 ) among 53 participants in a r and omized controlled trial . RESULTS The EI arm increased PA in relation to the SI arm at 3 months ( 18.4 to 186.0 min/wk vs. 20.9 to 57.3 min/wk ; p = .03 ) but between-groups differences were not observed at 6 months ( 176.8 vs. 133.5 min/wk ; p = .44 ) . EI participants maintained PA from 3 to 6 months ( 186.0 to 176.8 min/wk ) , and the SI group increased PA ( 57.3 to 133.5 min/wk ) . CONCLUSION The EI program was efficacious at improving PA levels in relation to publicly available Websites initially , but differences in PA levels were not maintained at 6 months . Future research should identify Internet features that promote long-term maintenance Background Identifying ways to promote physical activity and decrease sedentary time during childhood is a key public health issue . Research on the putative influences on preschool children ’s  physical activity ( PA ) and  sedentary behavior  ( SB ) is limited and has yielded inconsistent results . Our aim was to identify correlates of PA and SB in preschool children . Methods Cross-sectional data were drawn from the Swiss Preschoolers ’ Health Study ( SPLASHY ) , a Swiss population -based cohort study . Of 476 two to six year old children , 394 ( 54 % boys ) had valid PA data assessed by accelerometry .  Information on exposure data was directly measured or extracted from parental question naires . Multilevel linear regression modeling was used to separately assess associations between 35 potential correlates and  total PA ( TPA ) , moderate-to-vigorous PA ( MVPA ) and SB . Results In total , 12 correlates from different domains were identified . TPA and MVPA were greater in boys than girls , increased with age and were positively associated with gross motor skills . Children from single parent families had a higher level of TPA and spent less time sedentary than those living with two parents . Time spent outdoors was positively associated with TPA and negatively with SB . The child ’s activity temperament was related all three outcomes , whereas parental sports club membership , living area per person and neighborhood safety were associated with SB only . Fixed and r and om factors in the final models accounted for 28 % , 32 % and 22 % of the total variance in TPA , MVPA and SB , respectively . Variance decomposition revealed that age , sex and activity temperament were the most influential correlates of both , TPA and MVPA , whereas the child ’s activity temperament , time outdoors and neighborhood safety were identified as the most important correlates of SB . Conclusions A multidimensional set of correlates of young children ’s  activity behavior has been identified . Personal factors had the greatest influence on PA , whereas environmental-level factors had the greatest influence on SB . Moreover , we identified a number of previously unreported , potentially modifiable correlates of young children ’s PA and SB . These factors could serve to define target groups or become valuable targets for change in future interventions .Trial registration Current Controlled Trials IS RCT N41045021 ( date of registration : 21.03.14 ) Background Regular physical activity ( PA ) is a key contributor to healthy ageing . However , despite known health benefits , only one third of older adults in Germany reach the PA levels recommended for persons aged 65 years and above by the World Health Organization . The aim of the current study is to evaluate the effectiveness of two web-based interventions for the initiation and maintenance of regular PA ( i.e. , intervention groups 1 and 2 ) compared to a delayed intervention control group of older adults aged 65 to 75 years . Methods / Design Study participants will be r and omly assigned to one of three study arms in five communities in the Bremen-Oldenburg metropolitan region : a ) Participants in the first arm will receive access to a web-based intervention for 10 weeks allowing them to track their weekly PA ( subjective self-monitoring , intervention group 1 ) ; b ) participants in the second arm will receive access to the web-based intervention for 10 weeks and , in addition , track PA using Fitbit Zips ( objective self-monitoring , intervention group 2 ) ; c ) participants in the delayed intervention control group will receive access to the intervention implemented in the first study arm after completion of the 12-week follow-up in the other two groups within each community . In addition , weekly group meetings in the communities will be offered to study participants in the intervention groups providing the opportunity to address questions related to the use of the website and to practice PA in groups ( e.g. , neighborhood walks , strength and balance exercises ) . To evaluate short-term effects of the intervention on physical and psychological health , PA , physical fitness , and cognitive and psychological variables will be assessed at baseline and 12-week follow-up . Discussion This study will provide answers regarding acceptance and effectiveness of web-based interventions promoting uptake and maintenance of regular PA in persons aged 65–75 years . Study findings will contribute to a growing body of evidence in Germany concerning the role of community-based interventions for the promotion of PA and healthy ageing in older adults . Trial registration German Clinical Trials Register DRKS00010052 ( Date of registration 07–11 - 2016 ) Background Cancer and cancer treatment coincide with substantial negative physical , psychological and psychosocial problems .  Physical activity ( PA ) can positively affect the negative effects of cancer and cancer treatment and thereby increase quality of life in CPS . Nevertheless , only a minority of CPS meet PA guidelines . We developed the OncoActive ( OncoActief in Dutch ) intervention : a computer-tailored PA program to stimulate PA  in prostate and colorectal CPS , because to our knowledge there are only a few PA interventions for these specific cancer types in the Netherl and s Methods The OncoActive intervention was developed through systematic adaptation of a proven effective , evidence -based , computer-tailored PA  intervention for adults over fifty , called Active Plus . The Intervention Mapping ( IM ) protocol was used to guide the systematic adaptation . A literature study and interviews with prostate and colorectal CPS and health care professionals revealed that both general and cancer-specific PA determinants are important and should be addressed . Change objectives , theoretical methods and applications and the actual program content were adapted to address the specific needs , beliefs and cancer-related issues of prostate and colorectal CPS . Intervention participants  received tailored PA advice three times , on internet and with printed material s , and a pedometer to set goals to improve PA .  Pre- and pilot tests showed that the intervention was highly appreciated ( target group ) and regarded safe and feasible ( healthcare professionals ) . The effectiveness of the intervention is being evaluated in a r and omized controlled trial ( RCT ) ( n = 428 ) , consisting of an intervention group and a usual care waiting-list control group , with follow-up measurements at three , six and twelve months . Participants are recruited from seventeen hospitals and with posters , flyers and calls in several media . Discussion Using the Intervention Mapping protocol result ed in a systematic ally adapted , theory and evidence -based intervention providing tailored PA advice to prostate and colorectal CPS . If the intervention turns out to be effective in increasing PA , as evaluated in a RCT , possibilities for nationwide implementation and extension to other cancer types will be explored . Trial registration The study is registered in the Dutch Trial Register ( NTR4296 ) on November 23rd 2013 and can be accessed at http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=4296 AIMS Despite the known benefits , 60 % of individuals with diabetes do not engage in regular physical activity ( PA ) . This pilot study tested the effects of a counseling intervention using continuous glucose monitoring system ( CGMS ) feedback on PA self-efficacy , PA levels , and physiological variables . METHODS Adults ( N=52 ) with type 2 diabetes ( non-insulin requiring , inactive ) were r and omized to intervention ( n=27 ) or control ( n=25 ) groups . Both groups received 90min of diabetes education with a follow-up phone call 4 weeks later . The intervention group also received counseling derived from self-efficacy theory . This intervention included feedback on each participant 's CGMS graph and used role model CGMS graphs to clearly depict glucose reductions in response to PA . Outcomes were assessed at baseline and 8 weeks . RESULTS Participants receiving the intervention had higher self-efficacy scores than the control group for sticking to activity/resisting relapse at 8 weeks ( p<0.05 ) , indicating more confidence in maintaining a PA program . Intervention group participants light/sedentary activity minutes decreased significantly ( p<0.05 ) , moderate activity minutes increased significantly ( p<0.05 ) , and , HbA1c and BMI decreased significantly ( p<0.05 ) . CONCLUSIONS These data suggest that PA counseling interventions using CGMS feedback for individuals with type 2 diabetes may improve PA levels and reduce risk factors for diabetes-related complications Background If eHealth interventions are not used ( properly ) , their potential benefits can not be fulfilled . User perceptions of eHealth are an important determinant of its successful implementation . This study examined how patients with chronic obstructive pulmonary disease ( COPD ) and their physiotherapists ( PHTs ) value an eHealth self-management intervention following a period of use . Objective The study aim ed to evaluate the perceptions of COPD patients and their PHTs as eHealth users . Methods In this study , an eHealth self-management intervention ( website and mobile phone app ) aim ed at stimulating physical activity ( PA ) in COPD patients was evaluated by its users ( patients and PHTs ) . As participants in a r and omized controlled trial ( RCT ) , they were asked how they valued the eHealth intervention after 6 months ’ use . Interview requests were made to 33 PHTs from 26 participating practice s , and a question naire was sent to 76 patients . The question naire was analyzed in Excel ( Microsoft ) . The interviews with the PHTs and text messages ( short message service , SMS ) sent between patients and PHTs were transcribed and independently coded in MAXQDA 10 for Windows ( VERBI GmbH ) . Results A total of 60 patients with COPD filled out the question naire , and 24 PHTs were interviewed . The mobile phone app was used 89.0 % ( 160.2/180 days ) ( st and ard deviation [ SD ] 18.5 ) of the time by patients ; 53 % ( 13/24 ) of PHTs reported low or no use . Patients scored the ease of use of the app 5.09 ( SD 1.14 ) ( on a 7-point scale ) . They found the presentation of the PA information in the app to be clear , insightful , and stimulating . All PHTs judged the website as explicit and user-friendly but had trouble devising a new PA goal for their patients . Patients mostly sent informative , neutral messages concerning the PA goal , and PHTs sent mostly motivating , positive messages concerning the PA goal . Messages were not perceived as supportive in reaching the PA goal according to the patients . Perceived usefulness of the intervention for the PHTs was the objective measurement of PA , the ability to see PA patterns over time , and the ability to use the intervention as a tool to give their patients insight into their PA . For patients , it was that the intervention supported them in increasing their PA and that it made them feel fitter . Barriers to use of the intervention according to the PHTs were time constraints and financial reasons . Seventy-nine percent ( 19/24 ) of the PHTs and 58 % ( 35/60 ) of the patients mentioned they would be interested in using the intervention in the future . Conclusions PHTs and COPD patients had positive feelings regarding the functionality and potential of the eHealth self-management intervention . This paper addresses a number of topics that may aid in the successful development and implementation of these types of eHealth interventions in the future CMAJ • MAY 12 , 2009 • 180(10 ) © 2009 Canadian Medical Association or its licensors E47 R and omized trials have traditionally been broadly categorized as either an effectiveness trial or an efficacy trial , although we prefer the terms “ pragmatic ” and “ explanatory . ” Schwartz and Lellouch described these 2 approaches toward clinical trials in 1967 . These authors coined the term “ pragmatic ” to describe trials that help users choose between options for care , and “ explanatory ” to describe trials that test causal research hypotheses ( i.e. , that a given intervention causes a particular benefit ) . We take the view that , in general , pragmatic trials are primarily design ed to determine the effects of an intervention under the usual conditions in which it will be applied , whereas explanatory trials are primarily design ed to determine the effects of an intervention under ideal circumstances . Thus , these terms refer to a trial ’s purpose and , in turn , structure . The degree to which this purpose is met depends on decisions about how the trial is design ed and , ultimately , conducted . Very few trials are purely pragmatic or explanatory . For example , in an otherwise explanatory trial , there may be some aspect of the intervention that is beyond the investigator ’s control . Similarly , the act of conducting an otherwise pragmatic trial may impose some control result ing in the setting being not quite usual . For example , the very act of collecting data required for a trial that would not otherwise be collected in usual practice could be a sufficient trigger to modify participant behaviour in unanticipated ways . Further , several aspects of a trial are relevant , relating to choices of trial participants , health care practitioners , interventions , adherence to protocol and analysis . Thus , we are left with a multidimensional continuum rather than a dichotomy , and a particular trial may display varying levels of pragmatism across these dimensions . In this article , we describe an effort to develop a tool to assess and display the position of any given trial within the pragmatic – explanatory continuum . The primary aim of this tool is to help trialists assess the degree to which design decisions align with the trial ’s stated purpose ( decision-making v. explanation ) . Our tool differs , therefore , from that of Gartlehner and associates in that it is intended to inform trial design rather than provide a method of classifying trials for the purpose of systematic review s. It can , however , also be used by research funders , ethics committees , trial registers and journal editors to make the same assessment , provided trialists declare their intended purpose and adequately report their design decisions . Hence , reporting of pragmatic trials is addressed elsewhere OBJECTIVE Effectiveness of a behavioral modification program on  physical activity ( PA ) and sedentary behavior in diabetes patients . METHODS Ninety-two patients were r and omly assigned to an intervention or control group . The 24-weeks intervention consisted of a face-to-face session , pedometer and seven telephone follow-ups .  Mean selection criteria were 35 - 75 years ; 25 - 35 kg/m(2 ) ; ≤ 12 % HbA1c , treated for type 2 diabetes ; no PA limitations . PA and sedentary behavior were measured by pedometer , accelerometer and question naire over the short- ( 24 weeks ) and intermediate- ( 1 year ) term . RESULTS The intervention group increased their steps/day by 2744 , their total PA by 23 min/day ( p<0.001 ) and decreased their sedentary behavior by 23 min/day ( p<0.05 ) post-intervention . After 1 year the intervention group still had an increase of 1872 steps/day , 11 min/day total PA and a decrease of 12 min/day in sedentary behavior ( p<0.001 ) . CONCLUSION This pedometer-based behavioral modification program with telephone support showed lasting positive effects on steps/day , PA and sedentary behavior . PRACTICE IMPLICATION S This study tested a convenient way to increase PA among type 2 diabetes patients
A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation .
Although regular physical activity ( PA ) is a cornerstone of treatment for type 2 diabetes ( T2D ) , most adults with T2D are sedentary .
R and omized controlled trials ( RCTs ) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare setting s. We sought to identify PA interventions that are effective and practical to implement in clinical practice setting s. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 ( PRECIS-2 ) tool to assess the potential for future implementation of PA interventions in clinical practice setting s. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores .