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Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.
Kuningas, K, Driscoll, J, Mair, R, Smith, H, Dutton, M, Day, E, Sharif, AA
Transplantation. 2020;(7):1491-1499
Abstract
BACKGROUND New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven. METHODS We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints. RESULTS Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted. CONCLUSIONS Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
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Comprehensive lifestyle intervention vs soy protein-based meal regimen in non-alcoholic steatohepatitis.
Deibert, P, Lazaro, A, Schaffner, D, Berg, A, Koenig, D, Kreisel, W, Baumstark, MW, Steinmann, D, Buechert, M, Lange, T
World journal of gastroenterology. 2019;(9):1116-1131
Abstract
BACKGROUND Non-alcoholic steatohepatitis (NASH) has become one of the leading causes of liver disease in the western world. In obese patients weight reduction is recommended. Up to now there are no specific guidelines for weight loss in order to reduce hepatic fat content. AIM: To investigate the effects of a 24-wk guided lifestyle intervention program compared to a meal replacement regimen based on soy protein. METHODS Twenty-six subjects with NASH participated in a randomized single-center study. They were randomly assigned to either meal replacement group (MR-G) with soy-yogurt-honey preparation or to guided lifestyle change group (LC-G) with endurance activity and nutrition counselling. Serum alanine transaminase (ALT), aspartate transaminase (AST), lipid parameters, and adipokines were measured. Liver fat content and lipid composition were determined by magnetic resonance imaging and magnetic resonance spectroscopy. Body fat mass and lean body mass were assessed using Bod Pod® device. Pre- and post-intervention monitoring of parameters was performed. Statistical analyses were conducted with SPSS software, results were expressed as median (interquartile range). RESULTS Twenty-two subjects (MR-G, n = 11 and LC-G, n = 11) completed the study (9 women, 13 men; age 52.1 (15.0) years, body mass index (BMI) 32.3 (3.3) kg/m²). In both groups a significant weight loss was achieved (MR-G: -6.4 (3.6) kg, P < 0.01; LC-G: -9.1 (10.4) kg, P < 0.01). BMI dropped in both groups (MR-G: -2.3 (1.5) kg/m2, P = 0.003; LC-G: -3.0 (3.4) kg/m2, P = 0.006). Internal fat and hepatic lipid content were markedly reduced in both groups in comparable amount. There was a strong correlation between reduction in liver fat and decrease in ALT. Likewise, both groups showed an improvement in glycemic control and lipid profile. Changes in adipokines, particularly in adiponectin and leptin were closely related to intrahepatic lipid changes. CONCLUSION Comprehensive lifestyle intervention and meal replacement regimen have comparable effects on body and liver fat, as well as decrease in markers of hepatic inflammation among NASH patients.
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Examination of a board game approach to children's involvement in family-based weight management vs. traditional family-based behavioral counseling in primary care.
Sen, M, Uzuner, A, Akman, M, Bahadir, AT, Borekci, NO, Viggiano, E
European journal of pediatrics. 2018;(8):1231-1238
Abstract
UNLABELLED The most effective intervention model for childhood obesity is known as family-based behavioral group treatments. There are also studies that investigate the effects of educational games for children to gain healthy eating and physical exercise habits. The aim of this study was to compare the efficacy of a family-based group treatment with an educational game (Kaledo) intervention in childhood obesity. Kaledo is a board game that was designed to improve nutritional knowledge and healthy life style habits. It is played with nutrition and activity cards that players can select from, and a total score is calculated in the end of the game according to energy intake and expenditure. Obese children between 9 and 12 ages were involved in this study. Participants randomly divided into behavioral and game intervention groups. Clinical evaluation was performed in the first and second counseling in both groups. Marmara University Family Medicine Department Obese Children and Adolescents Interview Form, Physical Activity Evaluation Form, and Three-day Food Record Form were used for this purpose. Strengths and Difficulties Questionnaire-Parent Report Version and Children's Depression Inventory were used for the assessment of psychiatric symptoms. After the clinical evaluation, an education session about healthy eating and physical activity was attended by both groups. After that, for the behavioral groups, parents and children were assigned to different groups, while for the game intervention group, parents were assigned to behavioral sessions and children were assigned to game (Kaledo) sessions. A total of six sessions with 1-h duration and 2-week interval were performed in both groups. Height and weight were measured in each session and analysis was performed on the data of the children who participated in all of the sessions. Although a total of 108 children were clinically evaluated, 52 children and their parents, 26 in the behavioral group and 26 in the game intervention group, participated in two or more sessions. Twenty-four participants, 12 in behavioral and 12 in the game intervention group, finished the study by participating in all of the six sessions. Thus, dropout rate was 74%. BMI and BMI z-scores decreased in both groups compared with the initial measures and these changes were statistically significant. For the behavioral group, these changes were - 1.01 (25.44 to 24.43, p = 0.03) and - 0.17 (2.07 to 1.90, p = 0.000) and for the game group, - 0.74 (26.98 to 26.24, p = 0.007) and - 0.09 (2.07 to 1.98, p = 0.003). There were no significant differences between behavioral and game intervention groups in point of BMI and BMI z-scores (p = 0.130 and p = 0.706). CONCLUSION Family-based behavioral group treatment and game (Kaledo) intervention were found to be effective in childhood obesity management in this research. There was no significant difference between the two interventions. According to this study, these intervention models can be advised to primary care physicians to be used in the management of childhood obesity. What is Known: - Family-based behavioral group treatment is known as the most efficient model for childhood obesity management. What is New: - In this study, for the first time, a game (Kaledo) intervention was found to be effective in childhood obesity management. - Compared with family-based behavioral group treatment, there was no significant difference between the two interventions.
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7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group.
Reinehr, T, Bucksch, J, Müller, A, Finne, E, Kolip, P
Clinical nutrition (Edinburgh, Scotland). 2018;(5):1558-1562
Abstract
BACKGROUND & AIMS We present the 7-year follow-up analysis in overweight children and adolescents, who had participated originally in a randomized control trial of a lifestyle intervention. We compared them to an untreated population-based control group to demonstrate the effectiveness of the intervention. METHODS Degree of overweight (BMI-SDS) was determined in 32 overweight children (mean age 11.5 ± 1.5yrs, 65.6% females, mean BMI 23.7 ± 1.5 kg/m2) at onset of intervention (T0), end of 6-month intervention (T1), 12 months (T2) and 7 years after end of intervention (T3). A total of 76 overweight children derived from a representative national population survey served as control group. RESULTS The participants in the intervention group reduced significantly their BMI-SDS between T0-T1 (mean ± standard deviation -0.28 ± 0.28, p < 0.001) and demonstrated no significant changes between T1-T2 (mean ± standard deviation -0.10 ± 0.34) and between T2-T3 (median +0.07; interquartile range: -0.54-0.62). BMI-SDS at T3 was significantly (p = 0.015) lower compared to T0. At T3, 46.8% of the participants in the intervention were normal-weight. The reduction in BMI-SDS between T0-T3 was significantly (p = 0.043) greater in the intervention group (median -0.26; interquartile range -0.87-0.23 BMI-SDS) compared to the control group (mean ± standard deviation -0.05 ± 0.77). CONCLUSIONS The lifestyle intervention led to a significant reduction of overweight in the 7-year follow-up period. This decrease in BMI-SDS was significantly greater than the changes in BMI-SDS in a control group. This study is registered at clinicaltrials.gov (NCT00422916).
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Structured advice provided by a dietitian increases adherence of consumers to diet and lifestyle changes and lowers blood low-density lipoprotein (LDL)-cholesterol: the Increasing Adherence of Consumers to Diet & Lifestyle Changes to Lower (LDL) Cholesterol (ACT) randomised controlled trial.
Sialvera, TE, Papadopoulou, A, Efstathiou, SP, Trautwein, EA, Ras, RT, Kollia, N, Farajian, P, Goumas, G, Dimakopoulos, I, Papavasiliou, K, et al
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2018;(2):197-208
Abstract
BACKGROUND Evidence from healthcare professionals suggest that consumer compliance to healthy diet and lifestyle changes is often poor. The present study investigated the effect of advice provided by a physician or dietitian on consumer adherence to these measures combined with consuming foods with added plant sterols (PS) with the aim of lowering low-density lipoprotein cholesterol (LDL-C). METHODS One hundred mildly-to-moderately hypercholesterolaemic individuals were enrolled into a parallel, randomised, placebo-controlled study. Dietitians (dietitian group; DG) advised 50 individuals in six weekly face-to-face behavioural therapy sessions, whereas the other 50 received standard advice from physicians (physician group, PG). Both groups consumed foods with added PS (three servings a day) for 6 weeks. Subsequently, all individuals were followed-up for another 6 weeks under real-life conditions. Blood lipids were measured at baseline and weeks 6 and 12 and 3-day diet diaries were taken at weeks 1, 6 and 12. RESULTS Individuals in the DG significantly improved their dietary habits, physical activity and increased PS intake compared to the PG. After 6 weeks, LDL-C decreased in both groups compared to baseline without any significant differences between groups. At week 12, LDL-C was further significantly improved only in the DG (P = 0.006) compared to week 6. Total cholesterol, LDL-C and triglycerides were significantly lower in the DG compared to the PG at week 12 after adjusting for levels at week 6 (P < 0.001, P < 0.001 and P = 0.009, respectively). CONCLUSIONS Although structured counselling by dietitians and common standard advice by physicians were equally effective with respect to improving blood cholesterol after 6 weeks, dietitians were more effective in the longer-term (i.e. 6 weeks after the end of the intervention period).
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Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; A secondary analysis of a randomized controlled trial.
van Elten, TM, Karsten, MDA, Geelen, A, van Oers, AM, van Poppel, MNM, Groen, H, Gemke, RJBJ, Mol, BW, Mutsaerts, MAQ, Roseboom, TJ, et al
PloS one. 2018;(11):e0206888
Abstract
BACKGROUND Lifestyle changes are notoriously difficult. Since women who intend to become pregnant are more susceptible to lifestyle advice, interventions during this time window might be more effective than interventions during any other period in life. We here report the effects of the first large preconception lifestyle intervention RCT on diet and physical activity in obese infertile women. METHODS In total, 577 women were randomized between a six-month lifestyle intervention program (intervention group; N = 290) or prompt infertility treatment (control group; N = 287). Self-reported dietary behaviors and physical activity were assessed at baseline, three, six and twelve months after randomization. Mixed models were used to analyze differences between groups. RESULTS Compared to the control group, the intervention group reduced their intake of sugary drinks at three months (-0.5 glasses/day [95% C.I. = -0.9;-0.2]), of savory snacks at three (-2.4 handful/week [-3.4;-1.4]) and at six months (-1.4 handful/week [-2.6;-0.2]), and of sweet snacks at three (-2.2 portion/week [-3.3;-1.0]) and twelve months after randomization (-1.9 portion/week [-3.5;-0.4]). Also, the intervention group was more moderate to vigorous physically active at three months after randomization compared to the control group (169.0 minutes/week [6.0; 332.1]). CONCLUSION Our study showed that obese infertile women who followed a six-month preconception lifestyle intervention program decreased their intake of high caloric snacks and beverages, and increased their physical activity. These changes in lifestyle may not only improve women's health but their offspring's health too.
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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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Abstract
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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Comparing a telephone- and a group-delivered diabetes prevention program: Characteristics of engaged and non-engaged postpartum mothers with a history of gestational diabetes.
Lim, S, Dunbar, JA, Versace, VL, Janus, E, Wildey, C, Skinner, T, O'Reilly, S
Diabetes research and clinical practice. 2017;:254-262
Abstract
AIMS: To explore the acceptability of a telephone- or a group-delivered diabetes prevention program for women with previous gestational diabetes and to compare the characteristics associated with program engagement. METHODS Postpartum women participated in a lifestyle modification program delivered by telephone (n=33) or group format (n=284). Semi-structured interviews on barriers and enablers to program engagement (defined as completing≥80% sessions) were conducted before (Group) and after (Group and Telephone) interventions. The Health Action Process Approach theory was used as the framework for inquiry. Psychological measures were compared between engagement subgroups before and after group-delivered intervention. RESULTS In the telephone-delivered program 82% participants met the engagement criteria compared with 38% for the group-delivered program. Engaged participants (Group) had significantly higher risk perception, outcome expectancy, and activity self-efficacy at baseline (P<0.05). There was a greater decrease in body weight (-1.45±3.9 vs -0.26±3.5, P=0.024) and waist circumference (-3.56±5.1 vs -1.24±5.3, P=0.002) for engaged vs non-engaged participants following group program completion. CONCLUSIONS Telephone delivery was associated with greater engagement in postpartum women. Engagement was associated with greater reduction in weight and waist circumference. Further studies are required to confirm the effectiveness of telephone-delivered program for diabetes prevention in postpartum women.
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Effective behaviour change techniques for physical activity and healthy eating in overweight and obese adults; systematic review and meta-regression analyses.
Samdal, GB, Eide, GE, Barth, T, Williams, G, Meland, E
The international journal of behavioral nutrition and physical activity. 2017;(1):42
Abstract
PURPOSE This systematic review aims to explain the heterogeneity in results of interventions to promote physical activity and healthy eating for overweight and obese adults, by exploring the differential effects of behaviour change techniques (BCTs) and other intervention characteristics. METHODS The inclusion criteria specified RCTs with ≥ 12 weeks' duration, from January 2007 to October 2014, for adults (mean age ≥ 40 years, mean BMI ≥ 30). Primary outcomes were measures of healthy diet or physical activity. Two reviewers rated study quality, coded the BCTs, and collected outcome results at short (≤6 months) and long term (≥12 months). Meta-analyses and meta-regressions were used to estimate effect sizes (ES), heterogeneity indices (I2) and regression coefficients. RESULTS We included 48 studies containing a total of 82 outcome reports. The 32 long term reports had an overall ES = 0.24 with 95% confidence interval (CI): 0.15 to 0.33 and I2 = 59.4%. The 50 short term reports had an ES = 0.37 with 95% CI: 0.26 to 0.48, and I2 = 71.3%. The number of BCTs unique to the intervention group, and the BCTs goal setting and self-monitoring of behaviour predicted the effect at short and long term. The total number of BCTs in both intervention arms and using the BCTs goal setting of outcome, feedback on outcome of behaviour, implementing graded tasks, and adding objects to the environment, e.g. using a step counter, significantly predicted the effect at long term. Setting a goal for change; and the presence of reporting bias independently explained 58.8% of inter-study variation at short term. Autonomy supportive and person-centred methods as in Motivational Interviewing, the BCTs goal setting of behaviour, and receiving feedback on the outcome of behaviour, explained all of the between study variations in effects at long term. CONCLUSION There are similarities, but also differences in effective BCTs promoting change in healthy eating and physical activity and BCTs supporting maintenance of change. The results support the use of goal setting and self-monitoring of behaviour when counselling overweight and obese adults. Several other BCTs as well as the use of a person-centred and autonomy supportive counselling approach seem important in order to maintain behaviour over time. TRIAL REGISTRATION PROSPERO CRD42015020624.
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Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.
Wilcox, J, Waite, C, Tomlinson, L, Driscoll, J, Karim, A, Day, E, Sharif, A
Trials. 2016;(1):417
Abstract
BACKGROUND Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. METHODS/DESIGN We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. DISCUSSION This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. TRIAL REGISTRATION This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).