human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    
agent
A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    