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Lower nocturnal blood glucose response to a potato-based mixed evening meal compared to rice in individuals with type 2 diabetes.
Devlin, BL, Parr, EB, Radford, BE, Hawley, JA
Clinical nutrition (Edinburgh, Scotland). 2021;(4):2200-2209
Abstract
BACKGROUND & AIMS Guidelines for reducing postprandial blood glucose concentrations include avoiding high glycemic index (GI) foods, such as white potatoes. However, GI testing is often undertaken in the morning with foods consumed in isolation by non-clinical cohorts. We investigated the impact of potato preparation and consumption as part of a mixed-evening meal on postprandial and nocturnal glycemic responses, and postprandial insulin response, in individuals with Type 2 Diabetes Mellitus (T2DM). METHODS In a randomized, cross-over design, 24 males and females (age 58.3 ± 9.3 y; BMI: 31.7 ± 6.8 kg/m2) with T2DM (diet or metformin controlled) completed four experimental trials after consuming a standardized breakfast (25% daily energy intake (EI)) and lunch (35% EI). Dinner (40% EI) was consumed at 1800 h being either: 1) boiled potato (BOIL); 2) roasted potato (ROAST); 3) boiled potato cooled for 24 h (COOLED); or 4) basmati rice (CONTROL). Each meal contained 50% carbohydrate, 30% fat and 20% protein. Blood samples were collected prior to, immediately post meal and at 30-min intervals for a further 120 min. A continuous glucose monitor was worn to assess nocturnal interstitial glucose concentrations. RESULTS No differences were detected in postprandial venous glucose area under the curve (iAUC) between CONTROL and all three potato conditions. Postprandial insulin iAUC was greater following COOLED compared to CONTROL (P = 0.003; 95% CI: 18.9-111.72 miU/mL). No significant differences between CONTROL and BOIL or ROAST were detected for postprandial insulin concentrations. All potato meals resulted in lower nocturnal glucose AUC than CONTROL (P < 0.001; 95% CI 4.15-15.67 mmol/L x h). CONCLUSION Compared to an isoenergetic rice meal, boiled, roasted or boiled then cooled potato-based meals were not associated with unfavourable postprandial glucose responses or nocturnal glycemic control, and can be considered suitable for individuals with T2DM when consumed as part of a mixed-evening meal. CLINICAL TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry https://www.anzctr.org.au/, ACTRN 12618000480280.
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Diabetes Prevention Program Translation in the Veterans Health Administration.
Moin, T, Damschroder, LJ, AuYoung, M, Maciejewski, ML, Datta, SK, Weinreb, JE, Steinle, NI, Billington, C, Hughes, M, Makki, F, et al
American journal of preventive medicine. 2017;(1):70-77
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INTRODUCTION This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system. DESIGN Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions. SETTING/PARTICIPANTS Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014. INTERVENTION VA-DPP included 22 group-based intensive lifestyle change sessions. MAIN OUTCOME MEASURES Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016. RESULTS A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures. CONCLUSIONS VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE! PARTICIPANTS Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.
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Walking Away from Type 2 diabetes: a cluster randomized controlled trial.
Yates, T, Edwardson, CL, Henson, J, Gray, LJ, Ashra, NB, Troughton, J, Khunti, K, Davies, MJ
Diabetic medicine : a journal of the British Diabetic Association. 2017;(5):698-707
Abstract
AIMS: This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. METHODS Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. RESULTS Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. CONCLUSIONS A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months.
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Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches.
Browning, C, Chapman, A, Yang, H, Liu, S, Zhang, T, Enticott, JC, Thomas, SA
BMJ open. 2016;(3):e009319
Abstract
OBJECTIVE To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. DESIGN Pragmatic cluster randomised controlled trial (RCT). SETTING Community Health Stations (CHSs) in Fengtai district, Beijing, China. PARTICIPANTS Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. INTERVENTION Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. OUTCOME MEASURES Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. RESULTS At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI -0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference -2.38, 95% CI -4.64 to -0.12, p=0.039) and systolic BP (adjusted difference -3.57, 95% CI -6.08 to -1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. CONCLUSIONS In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. TRIAL REGISTRATION NUMBER ISRCTN01010526; Pre-results.
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Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial.
Rosas, LG, Lv, N, Xiao, L, Lewis, MA, Zavella, P, Kramer, MK, Luna, V, Ma, J
Contemporary clinical trials. 2016;:30-40
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UNLABELLED Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes. TRIAL REGISTRATION NCT02459691.
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Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial.
Denig, P, Schuling, J, Haaijer-Ruskamp, F, Voorham, J
BMJ (Clinical research ed.). 2014;:g5651
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OBJECTIVE To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions. DESIGN Pragmatic randomised controlled trial. SETTING 18 general practices in the north of the Netherlands. PARTICIPANTS 344 patients with type 2 diabetes aged ≤ 65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012: 225 were allocated to the intervention group and 119 to the usual care group. INTERVENTION The intervention comprised a decision aid for people with diabetes, with individually tailored risk information and treatment options for multiple risk factors. The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions. It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation. Four different formats of the decision aid were included for additional explorative analyses. MAIN OUTCOME MEASURES The primary outcome was the effects on patient empowerment for setting and achieving goals. The secondary outcomes were changes in the prescribing of drugs to regulate glucose, blood pressure, lipids, and albuminuria. Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention. RESULTS Of all intervention participants, 103 (46%) reported to have received the basic elements of the intervention. For the primary outcome analysis, 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included. The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group, which was not significantly different from that of the control group (mean difference after adjusting for baseline 0.039, 95% confidence interval -0.056 to 0.134). Lipid regulating drug treatment was intensified in 25% of intervention and 12% of control participants with increased cholesterol levels, which did not reach significance when the intervention was compared with the usual care group (odds ratio 2.54, 95% confidence interval 0.89 to 7.23). Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care (3.90, 1.29 to 11.80). No relevant or significant changes were seen for other treatments. CONCLUSION We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount. The aid was not used to its full extent in a substantial number of participants. TRIAL REGISTRATION Dutch trial register NTR1942.
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A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study.
Ferrara, A, Hedderson, MM, Albright, CL, Brown, SD, Ehrlich, SF, Caan, BJ, Sternfeld, B, Gordon, NP, Schmittdiel, JA, Gunderson, EP, et al
BMC pregnancy and childbirth. 2014;:21
Abstract
BACKGROUND Women with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level. METHODS/DESIGN The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks). DISCUSSION There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.