title: Mediators of physical activity change in a behavioral modification program for type 2 diabetes patients Clinic-based support to help overweight patients with type 2 diabetes increase physical activity and lose weight. General practice and social service partnership for better clinical outcomes, patient self efficacy and lifestyle behaviours of diabetic care: randomised control trial of a chronic care model No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity. Long-term lifestyle intervention lowers the incidence of stroke in Japanese patients with type 2 diabetes: a nationwide multicentre randomised controlled trial (the Japan Diabetes Complications Study) Dissemination of the Look AHEAD intensive lifestyle intervention in the United States Air Force: study rationale, design and methods. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Improving Diabetes Care and Health Measures Among Hispanics Using Community Health Workers Utility of a Web-based Intervention for Individuals With Type 2 Diabetes: The Impact on Physical Activity Levels and Glycemic Control Comparative effectiveness of patient education methods for type 2 diabetes: a randomized controlled trial. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care Efficacy of a self-management education program for people with type 2 diabetes: results of a 12 month trial. Effects of Self-Management Support on Structure, Process, and Outcomes Among Vulnerable Patients With Diabetes Validation of a counseling strategy to promote the adoption and the maintenance of physical activity by type 2 diabetic subjects. Multifactorial intervention in diabetes care using real-time monitoring and tailored feedback in type 2 diabetes Managing the Space between Visits: A Randomized Trial of Disease Management for Diabetes in a Community Health Center A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers Increasing Physical Activity in Belgian Type 2 Diabetes Patients: a Three-Arm Randomized Controlled Trial Beyond good intentions: The role of proactive coping in achieving sustained behavioural change in the context of diabetes management Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial Nurse-Led Behavioral Management of Diabetes and Hypertension in Community Practices: A Randomized Trial Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study [Group versus individual education for type-2 diabetes patients]. Evaluation of a nurse-care management system to improve outcomes in patients with complicated diabetes. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Early lifestyle intervention in patients with non-insulin-dependent diabetes mellitus and impaired glucose tolerance. Rethink Organization to iMprove Education and Outcomes (ROMEO) Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. Effectiveness of lifestyle counseling by certified expert nurse of Japan for non-insulin-treated diabetic outpatients: a 1-year randomized controlled trial. Lifestyle change and mobility in obese adults with type 2 diabetes. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention
abstract: Background Many studies have reported significant behavioral impact of physical activity interventions . However , few have examined changes in potential mediators of change preceding behavioral changes , result ing in a lack of information concerning how the intervention worked . Our purpose was to examine mediation effects of changes in psychosocial variables on changes in physical activity in type 2 diabetes patients . Methods Ninety-two patients ( 62 ± 9 years , 30 , 0 ± 2.5 kg/m2 , 69 % males ) participated in a r and omized controlled trial . The 24-week intervention was based on social-cognitive constructs and consisted of a face-to-face session , telephone follow-ups , and the use of a pedometer .  Social-cognitive variables and physical activity  ( device-based and self-reported ) were collected at baseline , after the 24-week intervention and at one year post-baseline . PA was measured by pedometer , accelerometer and question naire . Results Post-intervention physical activity changes were mediated by coping with relapse , changes in social norm , and social modeling from family members ( p ≤ 0.05 ) . One-year physical activity changes were mediated by coping with relapse , changes in social support from family and self-efficacy towards physical activity barriers ( p ≤ 0.05 ) Conclusions For patients with type 2 diabetes , initiatives to increase their physical activity could usefully focus on strategies for resuming regular patterns of activity , on engaging family social support and on building confidence about dealing with actual and perceived barriers to activity . Trial Registration NCT00903500 , Clinical Trials.gov BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss Background The International Diabetes Attitudes , Wishes , and Needs ( DAWN ) programmes have shown the existence of a critical gap in self management support and access to the support system . This study aims to evaluate the effectiveness of the diabetes mellitus ( DM ) self management programme , with partnership between general practice and social work , on clinical outcomes , patient self efficacy and lifestyle behaviours . Methods In this is single blind r and omised controlled trial , subjects were recruited from patients attending general outpatient clinics in the Hospital Authority New Territory East Cluster of Hong Kong . 157 subjects meeting the inclusion criteria completed the study and were r and omly assigned to the experimental or control group . The experimental group underwent the six sessions of weekly DM self management course with emphasis on self efficacy and participatory approach . The outcome measurements included HbA1c concentration , DM self efficacy scale , dietary behaviours , body mass index ( BMI ) , and waist : hip ratio . Results Baseline assessment observed no significant differences between experimental and control groups for the variables related to outcomes . For the experimental group , the proportion of subjects with normal HbA1c increased from 4.5 % ( 3/66 ) at baseline to 28.6 % ( 19/66 ) at week 28 ( p<0.001 ) , but there was insignificant improvement in the control group ( 3.9 % to 11.8 % , p=0.13 ) . Repeated measure of analysis of variance showed pronounced improvement in DM self efficacy scale and BMI among the experimental group with significant interaction . Dietary behaviours also improved significantly in the experimental group . Conclusion The DM care model with partnership between general practice and social work demonstrated better diabetic control with improvement of self efficacy and minimisation of risk behaviours . Trial registration Current Controlled Trials IS RCT N78882965 Abstract Objective . To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care . Design and setting . Cluster r and omised trial in general practice s. Intervention . Nurse-led structured diabetes care with a protocol , record keeping , reminders , and feedback , plus training in motivational interviewing and agenda setting . Subjects . Primary care nurses in 58 general practice s and their 940 type 2 diabetes patients with an HbA1c concentration above 7 % , and a body mass index ( BMI ) above 25 kg/m2 . Main outcome measures . HbA1c , diet , and physical activity ( medical records and patient question naires ) . Results . Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention , the comprehensive programme was no more effective than usual care after 14 months , as shown by HbA1c levels ( difference between groups = 0.13 ; CI 20.8–0.35 ) and diet ( fat ( difference between groups = 0.19 ; CI 20.82–1.21 ) ; vegetables ( difference between groups = 0.10 ; CI-0.21–0.41 ) ; fruit ( difference between groups = 20.02 ; CI 20.26–0.22 ) ) , and physical activity ( difference between groups = 21.15 ; CI 212.26–9.97 ) , or any of the other measures of clinical parameters , patient 's readiness to change , or quality of life . Conclusion . A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity . We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice Background The prevalence of type 2 diabetes is rising worldwide , as has been the global mean fasting plasma glucose level . This study aim ed to evaluate the effectiveness of a structured individual-based lifestyle education ( SILE ) program to reduce the hemoglobin A1c ( HbA1c ) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical setting s. Methods This was a 6-month prospect i ve cluster r and omized controlled trial in a primary care setting with r and omization at the practice level . Twenty general practitioners in 20 clinics in Kanagawa prefecture , Japan , were involved . 193 adults ( 51 % men , mean age 61.3 years ) with type 2 diabetes and HbA1c ≥6.5 % who received treatment in medical clinics were the participants .  A SILE program was implemented through 4 sessions with trained registered dietitians during the 6-month study period . Results were compared with those of a control group who received usual care . The primary endpoint was the change in HbA1c levels at 6 months from baseline . Secondary endpoints were the changes at 6 months from baseline in fasting plasma glucose , lipid profile , blood pressure , BMI , energy , and nutrient intakes ( whole day and each meal ) . Intention-to-treat analysis was conducted . Mixed-effects linear models were used to examine the effects of the treatment . Results The mean change at 6 months from baseline in HbA1c was a 0.7 % decrease in the intervention group ( n = 100 ) and a 0.2 % decrease in the control group ( n = 93 ) ( difference −0.5 % , 95%CI : -0.2 % to −0.8 % , p = 0.004 ) . After adjusting for baseline values and other factors , the difference was still significant ( p = 0.003 ~ 0.011 ) . The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day , breakfast , and lunch as shown in crude and adjusted models . A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant . These results were confirmed by several sensitivity analyses . Conclusions The SILE program that was provided in primary care setting s for patients with type 2 diabetes result ed in greater improvement in HbA1c levels than usual diabetes care and education . Trial registration OBJECTIVE To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase  moderate-intensity physical activity ( PA ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial conducted at seven practice s in central North Carolina , 200 African-American women , > or = 40 years of age with type 2 diabetes , were r and omized to one of three treatment conditions : clinic and community ( group A ) , clinic only ( group B ) , or minimal intervention ( group C ) . The clinic-based intervention ( groups A and B ) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practice s and attitudes ; the community-based intervention ( group A ) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was design ed to provide social support and reinforce behavior change goals ; and the minimal intervention ( group C ) consisted of educational pamphlets mailed to participants . The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer , which was worn while awake for 7 days . RESULTS Totals of 175 ( 88 % ) and 167 ( 84 % ) participants completed PA assessment at 6 and 12 months , respectively . For comparison of PA , the P value for overall group effect was 0.014 . Comparing group A with C , the difference in the average adjusted mean for PA was 44.1 kcal/day ( 95 % CI 13.1 - 75.1 , P = 0.0055 ) . Comparing group B with C , the difference in the average adjusted mean was 33.1 kcal/day ( 95 % CI 3.3 - 62.8 , P = 0.029 ) . The intervention was acceptable to participants : 88 % were very satisfied with clinic-based counseling to enhance PA , and 86 % indicated that the peer counselor 's role in the program was important . CONCLUSIONS The intervention was associated with a modest enhancement of PA and was acceptable to participants Aims /hypothesisThe aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes . Methods A total of 2,033 eligible Japanese men and women aged 40–70 years with type 2 diabetes from 59 institutes were r and omised to a conventional treatment group ( CON ) , which continued to receive the usual care , and a lifestyle intervention group ( INT ) , which received education on lifestyle modification regarding dietary habits , physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit , in addition to the usual care . R and omisation and open-label allocation were done by a central computer system . Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period . Results Although status of control of most classic cardiovascular risk factors , including body weight , glycaemia , serum lipids and BP , did not differ between groups during the study period , the incidence of stroke in the INT group ( 5.48/1,000 patient-years ) was significantly lower than in the CON group ( 9.52/1,000 patient-years ) by Kaplan – Meier analysis ( p = 0.02 by logrank test ) and by multivariate Cox analysis ( HR 0.62 , 95 % CI 0.39–0.98 , p = 0.04 ) . The incidence of CHD , retinopathy and nephropathy did not differ significantly between groups . Lipoprotein(a ) was another significant independent risk factor for stroke . Conclusions /interpretationThese findings suggest that lifestyle modification had limited effects on most typical control variables , but did have a significant effect on stroke incidence in patients with established type 2 diabetes . Clinical Trial Registration : UMIN-CTR C000000222 Funding : The Ministry of Health , Labour and Welfare , BACKGROUND Despite an increase in overweight and obesity similar to the civilian population , there have been few r and omized controlled trials examining behavioral weight management interventions in the military setting s. PURPOSE This paper describes the design , intervention development and analysis plan of the Fit Blue study , a r and omized controlled behavioral weight loss trial taking place in the United States Air Force . DESIGN This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention ( ILI ) , a counselor-initiated condition and a self-paced condition . Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommo date the military environment . CONCLUSIONS To our knowledge , this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general . If successful , this intervention could be disseminated to the entire U.S. Military as this project is design ed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population . Programs vali date d in military population s can have a major public health impact given that with 1.4 million active duty personnel , the Department of Defense is the nation 's largest employer . However , while this intervention is design ed for a military population and there are unique aspects of the military that may enhance weight loss interventions , the diversity of the study population should help inform obesity efforts in both civilian and military setting Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The increasing prevalence of diabetes and obesity , growing health disparities , and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers ( CHWs ) to provide economically sustainable and culturally relevant services . This prospect i ve r and omized design evaluated the relative effectiveness of a CHW intervention among Hispanic persons with newly diagnosed type 2 diabetes , as compared with usual clinic practice in three inner-city health centers . In sum , 189 Hispanic patients newly diagnosed with type 2 diabetes were r and omly assigned to one of three 6-month diabetes management approaches — CHW , case management , and st and ard provider care— and assessed for diabetes-related health measures and clinical indicators at baseline and postintervention . Participants in the CHW group achieved greater improvements than did the controls in program measures : health status , emergency department utilization , dietary habits , physical activity , and medication adherence . They also had 2.9 times greater odds of decreasing body mass index Despite the numerous benefits of physical activity for patients with diabetes , most healthcare providers in busy clinical setting s rarely find time to counsel their patients about it . A Web-based program for healthcare providers can be used as an effective counseling tool , when strategies are outlined for specific stages of readiness for physical activity . Seventy-three adults with type 2 diabetes were r and omly assigned to Web-based intervention , printed- material intervention , or usual care . After 12 weeks , the effects of the interventions on physical activity , fasting blood sugar , and glycosylated hemoglobin were evaluated . Both Web-based and printed material intervention , compared with usual care , were effective in increasing physical activity ( P < .001 ) and decreasing fasting blood sugar ( P<.01 ) and glycosylated hemoglobin ( P < .01 ) . Post hoc analysis for change scores indicated significant differences between Web-based intervention and usual care and between printed material intervention and usual care , but not between web-based and printed material intervention . The findings of this study support the value of Web-based and printed material interventions in healthcare counseling . With increasing Web access , the effectiveness of Web-based programs offered directly to patients needs to be tested BACKGROUND Group education for patients with suboptimally controlled diabetes has not been rigorously studied . METHODS A total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin ( HbA(1c ) ) concentrations of 7 % or higher were r and omized to ( 1 ) group education ( using the US Diabetes Conversation Map program ) , ( 2 ) individual education , or ( 3 ) usual care ( UC ; ie , no assigned education ) . Both education methods covered content as needed to meet national st and ards for diabetes self-management education and were delivered through accredited programs from 2008 to 2009 . General linear mixed-model methods assessed patient-level changes between treatment groups in mean HbA(1c ) levels from baseline to follow-up at 6.8 months . Secondary outcomes included mean change in general health status ( Medical Outcomes Study 12-Item Short Form Health Survey [ SF-12 ] ) , Problem Areas in Diabetes ( PAID ) , Diabetes Self-Efficacy ( DES-SF ) , Recommended Food Score ( RFS ) , and Physical Activity ( PA , min/wk ) . RESULTS Mean HbA(1c ) concentration decreased in all groups but significantly more with individual ( -0.51 % ) than group education ( -0.27 % ) ( P = .01 ) and UC ( -0.24 % ) ( P = .01 ) . The proportion of subjects with follow-up HbA(1c ) concentration lower than 7 % was greater for individual education ( 21.2 % ) than for group ( 13.9 % ) and UC ( 12.8 % ) ( P = .03 ) . Compared with UC , individual education ( but not group ) improved SF-12 physical component score ( + 1.88 ) ( P = .04 ) , PA ( + 42.95 min/wk ) ( P = .03 ) , and RFS ( + 0.63 ) ( P = .05 ) . Compared with group education , individual education reduced PAID ( -3.62 ) ( P = .02 ) and increased self-efficacy ( + 0.1 ) ( P = .04 ) . CONCLUSIONS Individual education for patients with established suboptimally controlled diabetes result ed in better glucose control outcomes than did group education using Conversation Maps . There was also a trend toward better psychosocial and behavioral outcomes with individual education . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00652509 Background Physical inactivity is a major public health problem . The It ’s LiFe ! monitoring and feedback tool embedded in the Self-Management Support Program ( SSP ) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care . Objective Our aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP . Methods This was a three-armed cluster r and omised controlled trial . Twenty four family practice s were r and omly assigned to one of three groups in which participants received the tool + SSP ( group 1 ) , the SSP ( group 2 ) , or care as usual ( group 3 ) . The primary outcome measure was minutes of physical activity per day . The secondary outcomes were general and exercise self-efficacy and quality of life . Outcomes were measured at baseline after the intervention ( 4 - 6 months ) , and 3 months thereafter . Results The group that received the entire intervention ( tool + SSP ) showed more physical activity directly after the intervention than Group 3 ( mean difference 11.73 , 95 % CI 6.21 - 17.25 ; P<.001 ) , and Group 2 ( mean difference 7.86 , 95 % CI 2.18 - 13.54 ; P=.003 ) . Three months after the intervention , this effect was still present and significant ( compared to Group 3 : mean difference 10.59 , 95 % CI 4.94 - 16.25 ; P<.001 ; compared to Group 2 : mean difference 9.41 , 95 % CI 3.70 - 15.11 ; P<.001 ) . There was no significant difference in effect between Groups 2 and 3 on both time points . There was no interaction effect for disease type . Conclusions The combination of counseling with the tool proved an effective way to stimulate physical activity . Counseling without the tool was not effective . Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended . Trial Registration Clinical Trials.gov : NCT01867970 , https:// clinical trials.gov/ct2/show/NCT01867970 ( archived by WebCite at http://www.webcitation.org/6a2qR5BSr ) Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years . Design Three year follow-up of a multicentre cluster r and omised controlled trial in primary care , with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 731 of the 824 participants included in the original trial were eligible for follow-up . Biomedical data were collected on 604 ( 82.6 % ) and question naire data on 513 ( 70.1 % ) participants . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) levels . The secondary outcomes were blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , emotional impact of diabetes , and drug use at three years . Results HbA1c levels at three years had decreased in both groups . After adjusting for baseline and cluster the difference was not significant ( difference −0.02 , 95 % confidence interval −0.22 to 0.17 ) . The groups did not differ for the other biomedical and lifestyle outcomes and drug use . The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years ( P<0.01 ) . Depression scores and quality of life did not differ at three years . Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs . Trial registration Current Controlled Trials IS RCT N17844016 AIM Patient education that enhances one 's self-management ability is of utmost importance for improving patient outcomes in chronic diseases . We developed a 12 month self-management education program for type 2 diabetes , based on a previous 6 month program , and examined its efficacy . METHODS A r and omized controlled trial was carried out on out patients with type 2 diabetes from two hospitals who met the criteria and gave consent to participate . They were r and omly divided into an intervention group that followed the program and a control group that followed usual clinical practise . The intervention group received < 30 min of monthly interviews based on the program 's textbook and biweekly telephone calls from a nurse educator throughout the 12 months . RESULTS Of the 50 participants in the intervention group and the 25 participants in the control group , 42 and 23 , respectively , completed the program ( a completion rate of 84.0 % ) . The body weight , HbA1c , self-efficacy , dietary and exercise stages , quality of life , diastolic blood pressure , and total cholesterol level were significant by two-way repeated- measures anova . As for changes over time within the groups , only the intervention group showed significant differences by Friedman 's test . The complication prevention behaviors showed a high implementation rate in the intervention group . The overall evaluation of this program by the participants was very high and , therefore , they highly recognized the need for this type of program . CONCLUSIONS Self-management education works successfully in relation to patients ' behavior modification skills , degree of goal attainment , and self-efficacy , consequently improving their health outcomes OBJECTIVE Despite the importance of self-management support ( SMS ) , few studies have compared SMS interventions , involved diverse population s , or entailed implementation in safety net setting s. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model . RESEARCH DESIGN AND METHODS A total of 339 out patients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial . Participants , more than half of whom spoke limited English , were uninsured , and /or had less than a high school education , were r and omly assigned to  usual care , interactive weekly automated telephone self-management support with nurse follow-up ( ATSM ) , or monthly group medical visits with physician and health educator facilitation ( GMV ) . We measured 1-year changes in structure ( Patient Assessment of Chronic Illness Care [ PACIC ] ) , communication processes ( Interpersonal Processes of Care [ IPC ] ) , and outcomes ( behavioral , functional , and metabolic ) . RESULTS Compared with the usual care group , the ATSM and GMV groups showed improvements in PACIC , with effect sizes of 0.48 and 0.50 , respectively ( P < 0.01 ) . Only the ATSM group showed improvements in IPC ( effect sizes 0.40 vs. usual care and 0.25 vs. GMV , P < 0.05 ) . Both SMS arms showed improvements in self-management behavior versus the usual care arm ( P < 0.05 ) , with gains being greater for the ATSM group than for the GMV group ( effect size 0.27 , P = 0.02 ) . The ATSM group had fewer bed days per month than the usual care group ( −1.7 days , P = 0.05 ) and the GMV group ( −2.3 days , P < 0.01 ) and less interference with daily activities than the usual care group ( odds ratio 0.37 , P = 0.02 ) . We observed no differences in A1C change . CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior . ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life OBJECTIVE There is enough evidence that physical activity is an effective therapeutic tool in the management of type 2 diabetes .  The present study was design ed to vali date a counseling strategy that could be used by physicians in their daily outpatient practice to promote the adoption and maintenance of physical activity by type 2 diabetic subjects . RESEARCH DESIGN AND METHODS The long-term ( 2-year ) efficacy of the  behavioral approach ( n = 182 ) was compared with usual care treatment  ( n = 158 ) in two matched , r and omized groups of patients with type 2 diabetes who had been referred to our Outpatient Diabetes Center . The outcome of the intervention was consistent patient achievement of an energy expenditure of > 10 metabolic equivalents (METs)-h/week through voluntary physical activity . RESULTS After 2 years , 69 % of the patients in the intervention group ( 27.1 + /- 2.0 METs x h/week ) and 18 % of the control group ( 4.1 + /- 0.8 METs x h/week ) achieved the target ( P < 0.001 ) with significant ( P < 0.001 ) improvements in BMI ( intervention group 28.9 + /- 0.2 versus control group 30.4 + /- 0.3 kg/m(2 ) ) and HbA(1c ) ( intervention group 7.0 + /- 0.1 versus control group 7.6 + /- 0.1 % ) . CONCLUSIONS This r and omized , controlled study shows that physicians can motivate most patients with type 2 diabetes to exercise long-term and emphasizes the value of individual behavioral approaches in daily practice Aims In 2011 , we demonstrated that an individualized health management system employing advanced medical information technology , design ated ubiquitous (u)-healthcare , was helpful in achieving glycemic control without hypoglycemia in patients with diabetes . Following this , we generated a new multidisciplinary u-healthcare system by upgrading our clinical decision support system ( CDSS ) rule engine and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package . Methods In a r and omized , controlled clinical trial , patients with type 2 diabetes aged over 60 years were assigned r and omly to a self-monitored blood glucose ( SMBG ) group  ( N = 50 ) or u-healthcare group ( N = 50 ) for 6 months . The primary endpoint was the proportion of patients achieving glycated hemoglobin ( HbA1c ) < 7 % without hypoglycemia . Changes in body composition and lipid profiles were also investigated . The u-healthcare group was educated to use a specially design ed glucometer and an activity monitor that automatically transferred test results to a hospital-based server . An automated CDSS rule engine generated and sent patient-specific messages about  glucose , diet , and physical activity to their mobile phones and a Web site . Results After 6 months of follow-up , the HbA1c level was significantly decreased in the u-healthcare group [ 8.0 ± 0.7 % ( 64.2 ± 8.8 mmol/mol ) to 7.3 ± 0.9 % ( 56.7 ± 9.9 mmol/mol ) ] compared with the SMBG group [ 8.1 ± 0.8 % ( 64.9 ± 9.1 mmol/mol ) to 7.9 ± 1.2 % ( 63.2 ± 12.3 mmol/mol ) ] ( P < 0.01 ) . The proportion of patients with HbA1c < 7 % without hypoglycemia was greater in the u-healthcare group ( 26 % ) than in the SMBG group ( 12 % ; P < 0.05 ) . Body fat mass decreased and lipid profiles improved in the u-healthcare group but not in the SMBG group . Conclusion This u-healthcare service provided effective management for older patients with type 2 diabetes ( Clinical Trial . Gov : NCT01137058 ) Background Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority population s.  Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients . Objective We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center . Design R and omized controlled trial . Participants All patients had type 2 diabetes , and the majority was Hispanic or African American . Most were urban-dwelling with low socioeconomic status , and nearly all had Medicaid or were uninsured . Measurements Clinical measures included glycemic control , blood pressure , lipid levels , and body mass index . Vali date d surveys were used to measure dietary habits and physical activity . Results A total of 146 patients were r and omized to the intervention and 149 to the control group .  Depressive symptoms were highly prevalent in both groups . Using an intention to treat analysis , there were no significant differences in the primary outcome ( HbA1c ) between the intervention and control groups at 12 months . There were also no significant differences for secondary clinical or behavioral outcome measures including BMI , systolic or diastolic blood pressure , LDL cholesterol , smoking , or intake of fruits and vegetables , or physical activity . Conclusions A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone 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 Background Pedometer-based physical activity programs have been typically delivered in a group format by a behavioral expert . An alternative strategy that builds on existing interactions is delivery through individual consultation by a general practitioner ( GP ) . These two delivery strategies have not been directly compared . Purpose To compare effectiveness of a 12-week physical activity ( PA ) intervention for type 2 diabetes patients delivered by a trained GP via an individual consultation or as group delivery by a behavioral expert . MethodS ixty-seven primary care participants ( mean age = 67.4 years , 70 % male ) from three Belgian general practice s were r and omized into three different treatment arms : ( 1 ) individual consultation ( n = 22 ) with three PA contacts with the patient 's GP ; ( 2 ) group counseling ( n = 21 ) with three PA group sessions delivered by a behavioral expert ; and ( 3 ) a control arm ( n = 24 ) receiving no intervention .  Participant inclusion criteria were ≤80 years ; 25–35 kg/m² ; ≤12 % HbA1c and reporting no PA limitations . Outcome measures were pedometer-determined steps/day , self-reported PA , and health parameters ( weight , body mass index , waist circumference , total cholesterol , fasting glucose , and HbA1c ) . Results Group counseling participants increased 1,706 steps/day over baseline significantly ( p ≤ 0.05 ) more than other treatment arms . Moreover , they increased their self-reported PA ( + 82 min/day ) , while control arm participants showed a decrease in PA ( p ≤ 0.05 ) . Participants of the individual consultation had a decrease in waist circumference ( −1.4 cm ) and HbA1c ( −0.32 % ) and a lower increase in total cholesterol ( + 7.2 mg/dl ) compared to the other treatment arms ( all p ≤ 0.05 ) . Conclusion Group counseling in type 2 diabetes patients improved PA , whereas individual consultations had an impact on some health outcomes on the short-term This study examines the effectiveness of a brief self-management intervention to support patients recently diagnosed with type-2 diabetes to achieve sustained improvements in their self-care behaviours . Based on proactive coping , the intervention emphasizes the crucial role of anticipation and planning in maintaining self-care behaviours . In a r and omised controlled trial among recent screen-detected patients , participants who received the intervention  were compared with usual-care controls , examining changes in proximal outcomes ( intentions , self-efficacy and proactive coping ) , self-care behaviour ( diet , physical activity and medication ) and weight over time ( 0 , 3 and 12 months ) . Subsequently , the contribution of proactive coping in predicting maintenance of behavioural change was analysed using stepwise hierarchical regression analyses , controlling for baseline self-care behaviour , patient characteristics , and intentions and self-efficacy as measured after the course . The intervention was effective in improving proximal outcomes and behaviour with regard to diet and physical activity , result ing in significant weight loss at 12 months . Furthermore , proactive coping was a better predictor of long-term self-management than either intentions or self-efficacy . Proactive coping thus offers new insights into behavioural maintenance theory and can be used to develop effective self-management interventions Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016 ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting BACKGROUND In type 2 diabetes mellitus the aetiology of long-term complications is multifactorial . We carried out a r and omised trial of stepwise intensive treatment or st and ard treatment of risk factors in patients with microalbuminuria . METHODS In this open , parallel trial patients were allocated st and ard treatment ( n=80 ) or intensive treatment ( n=80 ) .  St and ard treatment followed Danish guidelines . Intensive treatment was a stepwise implementation of behaviour modification , pharmacological therapy targeting hyperglycaemia , hypertension , dyslipidaemia , and microalbuminuria . The primary endpoint was the development of nephropathy ( median albumin excretion rate > 300 mg per 24 h in at least one of the two-yearly examinations ) . Secondary endpoints were the incidence or progression of diabetic retinopathy and neuropathy . FINDINGS The mean age was 55.1 years ( SD 7.2 ) and patients were followed up for 3.8 years ( 0.3 ) . Patients in the intensive group had significantly lower rates of progression to nephropathy ( odds ratio 0.27 [ 95 % CI 0 - 10 - 0.75 ] ) , progression of retinopathy ( 0.45 [ 0.21 - 0.95 ] ) , and progression of autonomic neuropathy ( 0.32 [ 0.12 - 0.78 ] ) than those in the st and ard group . INTERPRETATION Intensified multifactorial intervention in patients with type 2 diabetes and microalbuminuria slows progression to nephropathy , and progression of retinopathy and autonomic neuropathy . However , further studies are needed to establish the effect of intensified multifactorial treatment on macrovascular complications and mortality OBJECTIVES To compare the effectiveness of group ( GE ) and individual ( IE ) health education in type-2 diabetes patients , and identify the improvement in knowledge , metabolic control and risk factors . DESIGN R and omised clinical trial . SETTING Primary care . Participants . 68 patients with type-2 diabetes , diagnosed 6 months before the start of the study and who had not received GE . Patients aged over 75 , those with sensory , psychological and /or physical deficiencies and those not monitored in primary care were excluded ( alpha=0.05 ; beta=0.2 ) . Interventions . Patients were selected according to the inclusion criteria and allocated at r and om to the IE ( n=33 ) or GE ( n=35 ) group . Individual and group lessons were given at the same time for a year . The contents were evaluated with a vali date d , self-administered test . MAIN MEASUREMENTS General , demographic variables , analyses , blood pressure , the Body Mass Index ( BMI ) , the presence of cardiovascular risk factors , diabetes-related complications and therapeutic variables were all measured . RESULTS The two kinds of education showed no significant differences from each other . The two groups improved the level of knowledge ( P<0.001 ) , and reduced HbA1c ( P<0.001 ) , HDL-C ( P<0.001 ) , the BMI ( P=0.001 ) and systolic pressure ( P=0.004 ) , and increased their use of reactive strips ( P=0.02 ) . CONCLUSIONS Health education on diabetes improved knowledge of the disease , metabolic control and cardiovascular risk factors . The two educational methods evaluated were equally effective OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities .  HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( < 7.5 % ) than patients in usual care ( 42.6 vs. 24.6 % , P < 0.03 , chi(2 ) ) . There were no significant differences in any of the psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits BACKGROUND  Diabetes mellitus ( DM ) group clinics  can effectively control hypertension , but data to support glycemic control are equivocal . This study evaluated the comparative effectiveness of 2 DM group clinic interventions on glycosylated hemoglobin ( HbA(1c ) ) levels in primary care . METHODS Eighty-seven participants were recruited from a DM registry of a single regional Veterans Affairs medical center to participate in an open , r and omized comparative effectiveness study . Two primary care-based DM group interventions of 3 months ' duration were compared . Empowering Patients in Care ( EPIC ) was a clinician-led , patient-centered group clinic consisting of 4 sessions on setting self-management action plans ( diet , exercise , home monitoring , medications , etc ) and communicating about progress with action plans . The comparison intervention consisted of group education sessions with a DM educator and dietician followed by an additional visit with one 's primary care provider .  Hemoglobin A(1c ) levels were compared after intervention and at the 1-year follow-up . RESULTS Participants in the EPIC intervention had significantly greater improvements in HbA(1c ) levels immediately following the active intervention ( 8.86%-8.04 % vs 8.74%-8.70 % of total hemoglobin ; mean [ SD ] between-group difference 0.67 % [ 1.3 % ] ; P=.03 ) , and these differences persisted at the 1 year follow-up ( 0.59 % [ 1.4 % ] , P=.05 ) . A repeated- measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA(1c ) levels favoring the EPIC intervention ( F(2,85)=3.55 ; P=.03 ) . The effect of the time-by-treatment interaction seems to be partially mediated by DM self-efficacy ( F(1,85)=10.39 ; P=.002 ) . CONCLUSION Primary care-based DM group clinics that include structured goal - setting approaches to self-management can significantly improve HbA(1c ) levels after intervention and maintain improvements for 1 year . Trial Registration clinical trials.gov Identifier : NCT00481286 AIMS To estimate the efficacy of a self-monitoring-based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy . METHODS This was an open-label , r and omized , pilot study , primarily led by diabetes nurses . Patients were r and omly allocated to either a self-monitoring-based disease management strategy or usual care ( ratio 3:1 ) and followed up for 6 months . Education was centred on how to modify lifestyle according self-monitoring readings .  Self-monitoring of blood glucose results were discussed during monthly telephone contact . The primary endpoint was mean change in HbA(1c ) levels , estimated with an ANOVA for repeated measures . All analyses were intention to treat . RESULTS Three diabetic clinics recruited 62 patients , of whom five were lost to follow-up . At baseline , both groups had a  mean HbA(1c ) value of 7.9 % ± 0.6 % ( 63 ± 6 mmol/mol ) . After 6 months , mean HbA(1c ) reduction was 1.2 ± 0.1 % ( -13 ± 1 mmol/mol ) in the intervention group and 0.7 ± 0.2 (-8 ± 2 mmol/mol ) in the control group , with an absolute mean difference between groups of -0.5 % ( 95 % CI -0.9 to -0.0 % ; P = 0.04 ) ( -5 mmol/mol , 95 % CI -10 to 0 ) . At study end , 61.9 % of patients in the intervention group and 20.0 % in the control group reached the target level of HbA(1c ) < 7.0 % ( < 53 mmol/mol ) ( P = 0.005 ) . Body weight reduction was significantly greater in the intervention group than in the control group ( between-group absolute mean difference : -3.99 kg ; 95 % CI -7.26 to -0.73 ; P = 0.02 ) . Therapy changes were more frequent in the control group . CONCLUSIONS A self-monitoring disease management strategy , primarily led by diabetes nurses and allowing a timely and efficient use of self-monitoring readings , is able to improve metabolic control , primarily through lifestyle modifications leading to weight loss Non-insulin-dependent diabetes mellitus ( NIDDM ) is preceded by impaired glucose tolerance ( IGT ) lasting for years before manifesting as overt hyperglycaemia . Both genetic and environmental factors contribute to the development of IGT and NIDDM . Obesity , physical inactivity and high-fat diet have been found to predict IGT and NIDDM . Therefore , a diet and exercise intervention from diagnosis of NIDDM could improve the treatment outcome and prognosis of patients with NIDDM . Furthermore , because subjects with IGT are at increased risk for diabetes and atherosclerotic vascular disease , it is reasonable to assume that in terms of reducing the incidence and longterm consequences of NIDDM an intervention at this phase is more effective than in overt diabetes . Although the nonpharmacological approach is generally accepted as the first-line treatment of NIDDM its efficacy has often been question ed . Therefore , it is important to carry out long-term controlled studies to find out to what extent lifestyle modification could improve the metabolic control and level of major cardiovascular risk factors known to be associated with poor outcome in NIDDM . This kind of study also gave relevant experience in planning studies aim ing at primary prevention of NIDDM . One-year dietary and exercise intervention on newly diagnosed NIDDM patients in Kuopio , Finl and result ed in a better metabolic control and a moderate reduction in cardiovascular risk factors as compared to the conventional treatment group . After the second year of follow-up only 12.5 % in the intervention group were receiving  oral antidiabetic drugs  vs. 34.8 % in the conventional treatment group . Weight reduction and a reduced use of saturated fats appeared to be the main determinants of successful treatment results . Good aerobic capacity was associated with an increase in HDL cholesterol . A multicentre primary prevention study on IGT patients is continuing in Finl and applying the same principles of intervention as used in the study on newly diagnosed NIDDM patients . Pilot results show that glucose tolerance can be improved by lifestyle changes OBJECTIVE A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics . RESEARCH DESIGN AND METHODS This study was a 4-year , two-armed , multicenter controlled trial in 13 hospital-based diabetes clinics in Italy ( current controlled trials no. IS RCT N19509463 ) . A total of 815 non – insulin-treated patients aged < 80 years with ≥1 year known diabetes duration were r and omized to either group or individual care . RESULTS After 4 years , patients in group care had lower A1C , total cholesterol , LDL cholesterol , triglycerides , systolic and diastolic blood pressure , BMI , and serum creatinine and higher HDL cholesterol ( P < 0.001 , for all ) than control subjects receiving individual care , despite similar pharmacological prescriptions . Health behaviors , quality of life , and knowledge of diabetes had become better in group care patients than in control subjects ( P < 0.001 , for all ) . CONCLUSIONS The favorable clinical , cognitive , and psychological outcomes of group care can be reproduced in different clinical setting BACKGROUND Glycemic goals ( hemoglobin A1c < 7 % ) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications . Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes . Diabetes prevalence and mortality are increasing rapidly in Jordan . Nevertheless , clinical pharmacists in Jordan do not typically provide pharmaceutical care ; instead , the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians . OBJECTIVE To assess the primary clinical outcome of glycemic control ( A1c ) and secondary outcomes , including blood pressure , lipid values , self-reported medication adherence , and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic r and omly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program . METHODS Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and r and omly assigned to intervention and usual care groups using the Minim software technique . The intervention group at baseline received face-to-face objective -directed education from a clinical pharmacist about type 2 diabetes , prescription medications , and necessary lifestyle changes , followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns . The primary outcome measure was glycemic control ( A1c ) , and secondary measures included systolic and diastolic blood pressure , complete lipid profile ( i.e. , total cholesterol , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , serum triglycerides ) , and self-reported medication adherence ( 4-item Morisky Scale ) and self-care activities ( Summary of Diabetes Self-Care Activities question naire ) . Data were collected at baseline and at 6 months follow-up . Changes from baseline to follow-up were calculated for biomarker values , and between-group differences in the change amounts were tested using the t test for independent sample s. A P value of < 0.05 was considered statistically significant . RESULTS A total of 77 of 85 patients ( 90.6 % ) r and omly assigned to the intervention group and 79 of 86 patients ( 91.9 % ) assigned to usual care had baseline and 6-month follow-up values . Compared with baseline values , patients in the intervention group had a mean reduction of 0.8 % in A1c versus a mean increase of 0.1 % from baseline in the usual care group ( P = 0.019 ) . The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose , systolic and diastolic blood pressure , total cholesterol , LDL-C , serum triglycerides , self-reported medication adherence , and self-care activities . Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant . CONCLUSIONS Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group . Six of 8 secondary biomarkers were improved in the intervention group compared with usual care We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic out patients by a Certified Expert Nurse ( CEN ) can improve patients ' health outcomes . Participants were r and omly assigned to a 1-year lifestyle intervention ( n=67 ) or to a usual care group ( n=67 ) . Main outcome measures were changes from baseline in : HbA(1C ) and score of health related quality of life scales ( SF-36 and Problem Areas in Diabetes Scale ) . Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items . We found no significant differences in HbA(1C ) , BMI , blood pressure , serum lipids , or health related quality of life over 1 year between the two groups . Patients in the intervention group , however , showed modest but more favorable modification of cognition ( p=0.004 ) and behavior ( p<0.001 ) than subjects in usual care group . The low attrition rate ( 9 % ) , more frequent hospital visit ( 12+/-2 times versus 11+/-3 times ; p=0.03 ) and high degree of satisfaction ( 95 % ) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient setting s of Japanese hospitals . Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention BACKGROUND Adults with type 2 diabetes mellitus often have limitations in mobility that increase with age . An intensive lifestyle intervention that produces weight loss and improves fitness could slow the loss of mobility in such patients . METHODS We r and omly assigned 5145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes to either an intensive lifestyle intervention or a diabetes support- and -education program ; 5016 participants contributed data . We used hidden Markov models to characterize disability states and mixed-effects ordinal logistic regression to estimate the probability of functional decline . The primary outcome was self-reported limitation in mobility , with annual assessment s for 4 years . RESULTS At year 4 , among 2514 adults in the lifestyle-intervention group , 517 ( 20.6 % ) had severe disability and 969 ( 38.5 % ) had good mobility ; the numbers among 2502 participants in the support group were 656 ( 26.2 % ) and 798 ( 31.9 % ) , respectively . The lifestyle-intervention group had a relative reduction of 48 % in the risk of loss of mobility , as compared with the support group ( odds ratio , 0.52 ; 95 % confidence interval , 0.44 to 0.63 ; P<0.001 ) . Both weight loss and improved fitness ( as assessed on treadmill testing ) were significant mediators of this effect ( P<0.001 for both variables ) . Adverse events that were related to the lifestyle intervention included a slightly higher frequency of musculoskeletal symptoms at year 1 . CONCLUSIONS Weight loss and improved fitness slowed the decline in mobility in overweight adults with type 2 diabetes . ( Funded by the Department of Health and Human Services and others ; Clinical Trials.gov number , NCT00017953 . ) Objectives : Physical activity ( PA ) has the potential to improve outcomes in both arthritis and diabetes , but these conditions are rarely examined together . Our objective was to explore whether persons with arthritis alone or those with both arthritis and diabetes could improve amounts of PA  with a home-based counselling intervention . Methods : As part of the Veterans LIFE ( Learning to Improve Fitness and Function in Elders ) Study , veterans aged 70–92 were r and omized to usual care or a 12-month PA counselling programme .  Arthritis and diabetes were assessed by self-report . Mixed models were used to compare trajectories for minutes of endurance and strength training PA for persons with no arthritis ( n = 85 ) , arthritis ( n = 178 ) , and arthritis plus diabetes ( n = 84 ) . Results : Recipients of PA counselling increased minutes of PA per week independent of disease status ( treatment arm by time interaction p < 0.05 for both ; endurance training time p = 0.0006 and strength training time p < 0.0001 ) . Although PA was lower at each wave among persons with arthritis , and even more so among persons with arthritis plus diabetes , the presence of these conditions did not significantly influence response to the intervention ( arthritis/diabetes group × time interactions p > 0.05 for both outcomes ) as each group experienced a nearly twofold or greater increase in PA  . Conclusions : A home-based PA intervention was effective in increasing minutes of weekly moderate intensity endurance and strength training PA in older veterans , even among those with arthritis or arthritis plus diabetes . This programme may serve as a useful model to improve outcomes in older persons with these pervasive diseases
target: A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation .
background: 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 .