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Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial.

ABSTRACT: Low physical activity and reduced physical functioning are common after renal transplantation, resulting in a reduced quality of life. Another common post-transplantation complication is poor cardio-metabolic health, which plays a main role in long-term outcomes in renal transplant recipients (RTR). It is increasingly recognized that weight gain in the first year after transplantation, especially an increase in fat mass, is a highly common contributor to cardio-metabolic risk. The aim of this study is to compare the outcomes of usual care to the effects of exercise alone, and exercise combined with dietary counseling, on physical functioning, quality of life and post-transplantation weight gain in RTR.The Active Care after Transplantation study is a multicenter randomized controlled trial with three arms in which RTR from 3 Dutch hospitals are randomized within the first year after transplantation to usual care, to exercise intervention (3 months supervised exercise 2 times per week followed by 12 months active follow-up), or to an exercise + diet intervention, consisting of the exercise training with additional dietary counseling (12 sessions over 15 months by a renal dietician). In total, 219 participants (73 per group) will be recruited. The primary outcome is the subdomain physical functioning of quality of life, (SF-36 PF). Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Furthermore, data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness are collected.Evidence on the effectiveness of an exercise intervention, or an exercise + diet intervention on physical functioning, weight gain and cardiometabolic health in RTR is currently lacking. The outcomes of the present study may help to guide future evidence-based lifestyle care after renal transplantation.Number: NCT01047410 .

SUBMITTER: Klaassen G

PROVIDER: S-EPMC5599936 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial.

Klaassen Gerald G Zelle Dorien M DM Navis Gerjan J GJ Dijkema Desie D Bemelman Frederike J FJ Bakker Stephan J L SJL Corpeleijn Eva E

BMC nephrology 20170915 1

<h4>Background</h4>Low physical activity and reduced physical functioning are common after renal transplantation, resulting in a reduced quality of life. Another common post-transplantation complication is poor cardio-metabolic health, which plays a main role in long-term outcomes in renal transplant recipients (RTR). It is increasingly recognized that weight gain in the first year after transplantation, especially an increase in fat mass, is a highly common contributor to cardio-metabolic risk. ...[more]

PMID: 28915863

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Project description:Excessive gestational weight gain (GWG) is associated with elevated weight retention in mothers and might be related to adiposity of their offspring. Little is known if lifestyle intervention during pregnancy has beneficial effects for mothers and children beyond gestation.A cluster-randomized controlled intervention trial was performed with 250 pregnant women in 8 gynaecological practices. Lifestyle intervention was carried out twice with individual counselling sessions on nutrition, physical activity and weight monitoring. Participants in the control group received routine prenatal care and an information leaflet. Follow-up data of women and their offspring were collected one year postpartum (pp) by phone call and/or via e-mail using a structured questionnaire. Maternal weight retention at 12 months pp and weight development of the children in their first year of life was compared between groups using linear regression. The association between energy and macronutrient intake during pregnancy with maternal weight retention and children weight development was also assessed.The intervention resulted in a trend towards lower mean weight retention 12 months pp (0.2 vs. 0.8 kg), but was not statistically significant (p = 0.321). Among women receiving lifestyle counselling, only 8% retained more than 5 kg weight while 17% in the control group retained >5 kg (OR: 0.40 (95% CI: 0.16, 0.97)). For the whole study cohort, an association between higher GWG and increased 12 month weight retention was found (0.4 kg weight retention per 1 kg increase in GWG, p < 0.001). Weight development of the infants did not differ between groups in the first months after birth. At the 10th-12th month weight measurement, infants born to mothers in the intervention group tended towards lower body weights. Both energy intake and macronutrient composition of the diet during pregnancy did not affect maternal weight retention and weight development of the infants.Lifestyle counselling during pregnancy to avoid GWG had a rather modest effect on maternal pp weight retention and weight development of the infants. However, larger intervention studies and longer follow-up are required to be able to draw definite conclusions.German Clinical Trials Register DRKS00003801.

Project description:ImportancePersonalized interventions that leverage workplace data and environments could improve effectiveness, sustainability, and scalability of employee wellness programs.ObjectiveTo test an automated behavioral intervention to prevent weight gain and improve diet using employee cafeteria purchasing data.Design, setting, and participantsThis individual-level randomized clinical trial of a 12-month intervention with 12 months of follow-up was conducted among employees of a hospital in Boston, Massachusetts, who purchased food at on-site cafeterias that used traffic-light labels (ie, green indicates healthy; yellow, less healthy; red, unhealthy). Participants were enrolled September 2016 to February 2018. Data were analyzed from May to September 2020.InterventionsFor 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Emails and letters were automatically generated using survey, health, and cafeteria data. Control group participants received 1 letter per month with general healthy lifestyle information.Main outcomes and measuresThe main outcome was change in weight from baseline to 12 months and 24 months of follow-up. Secondary outcomes included changes in cafeteria purchases, including proportion of green- and red-labeled purchases and calories purchased per day, from baseline (12 months preintervention) to the intervention (months 1-12) and follow-up (months 13-24) periods. Baseline Healthy Eating Index-15 (HEI-15) scores were compared to HEI-15 scores at 6, 12, and 24 months.ResultsAmong 602 employees enrolled (mean [SD] age, 43.6 [12.2] years; 478 [79.4%] women), 299 were randomized to the intervention group and 303 were randomized to the control group. Baseline mean (SD) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 28.3 (6.6) and HEI-15 score was 60.4 (12.4). There were no between-group differences in weight change at 12 (0.2 [95% CI, -0.6 to 1.0] kg) or 24 (0.6 [95% CI, -0.3 to 1.4] kg) months. Compared with baseline, the intervention group increased green-labeled purchases by 7.3% (95% CI, 5.4% to 9.3%) and decreased red-labeled purchases by 3.9% (95% CI, -5.0% to -2.7%) and calories purchased per day by 49.5 (95% CI, -75.2 to -23.9) kcal more than the control group during the intervention period. In the intervention group, differences in changes in green (4.8% [95% CI, 2.9% to 6.8%]) and red purchases (-3.1% [95% CI, -4.3% to -2.0%]) were sustained at the 24-month follow-up. Differences in changes in HEI-15 scores were not significantly different in the intervention compared with the control group at 6 (2.2 [95% CI, 0 to 4.4]), 12 (1.8 [95% CI, -0.6 to 4.1]), and 24 (1.6, 95% CI, -0.7 to 3.8]) months.Conclusions and relevanceThe findings of this randomized clinical trial suggest that an automated behavioral intervention using workplace cafeteria data improved employees' food choices but did not prevent weight gain over 2 years.Trial registrationClinicalTrials.gov Identifier: NCT02660086.

Project description:BACKGROUND:Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS:The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS:The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION:In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION:NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.

Project description:ObjectiveThe aim of the current study was to evaluate the effects of and adherence to an active video game promotion intervention on anthropometrics, sedentary screen time and consumption of sugar-sweetened beverages and snacks among non-active video gaming adolescents who primarily were of healthy weight.MethodsWe assigned 270 gaming (i.e. ? 2 hours/week non-active video game time) adolescents randomly to an intervention group (n = 140) (receiving active video games and encouragement to play) or a waiting-list control group (n = 130). BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds were measured at baseline, at four and ten months follow-up (primary outcomes). Sedentary screen time, physical activity, consumption of sugar-sweetened beverages and snacks, and process measures (not at baseline) were assessed with self-reports at baseline, one, four and ten months follow-up. Multi-level-intention to treat-regression analyses were conducted.ResultsThe control group decreased significantly more than the intervention group on BMI-SDS (? = 0.074, 95%CI: 0.008;0.14), and sum of skinfolds (? = 3.22, 95%CI: 0.27;6.17) (overall effects). The intervention group had a significantly higher decrease in self-reported non-active video game time (? = -1.76, 95%CI: -3.20;-0.32) and total sedentary screen time (Exp (? = 0.81, 95%CI: 0.74;0.88) than the control group (overall effects). The process evaluation showed that 14% of the adolescents played the Move video games every week ? 1 hour/week during the whole intervention period.ConclusionsThe active video game intervention did not result in lower values on anthropometrics in a group of 'excessive' non-active video gamers (mean ~ 14 hours/week) who primarily were of healthy weight compared to a control group throughout a ten-month-period. Even some effects in the unexpected direction were found, with the control group showing lower BMI-SDS and skin folds than the intervention group. The intervention did result in less self-reported sedentary screen time, although these results are likely biased by social desirability.Trial registrationDutch Trial Register NTR3228.

Project description:BackgroundOverweight and obesity amongst women of reproductive age are increasingly common in developed economies and are shown to adversely affect birth outcomes and both childhood and adulthood health risks in the offspring. Metabolic profiling in conditions of overweight and obesity in pregnancy could potentially be applied to elucidate the molecular basis of the adverse effects of gestational weight gain (GWG) and postpartum weight loss (WL) on future risks for cardiovascular disease (CVD) and other chronic diseases.MethodsBiofluid samples were collected from 114 ethnically diverse pregnant women with body mass index (BMI) between 25 and 40 kg/m2 from Chicago (US), as part of a randomized lifestyle intervention trial (Maternal Offspring Metabolics: Family Intervention Trial; NCT01631747). At 15 weeks, 35 weeks of gestation, and at 1 year postpartum, the blood plasma lipidome and metabolic profile of urine samples were analyzed by liquid chromatography mass spectrometry (LC-MS) and 1H nuclear magnetic resonance spectroscopy (1H NMR) respectively.ResultsUrinary 4-deoxyerythronic acid and 4-deoxythreonic acid were found to be positively correlated to BMI. Seventeen plasma lipids were found to be associated with GWG and 16 lipids were found to be associated with WL, which included phosphatidylinositols (PI), phosphatidylcholines (PC), lysophospholipids (lyso-), sphingomyelins (SM) and ether phosphatidylcholine (PC-O). Three phospholipids found to be positively associated with GWG all contained palmitate side-chains, and amongst the 14 lipids that were negatively associated with GWG, seven were PC-O. Six of eight lipids found to be negatively associated with WL contained an 18:2 fatty acid side-chain.ConclusionsMaternal obesity was associated with characteristic urine and plasma metabolic phenotypes, and phospholipid profile was found to be associated with both GWG and postpartum WL in metabolically healthy pregnant women with overweight/obesity. Postpartum WL may be linked to the reduction in the intake of linoleic acid/conjugated linoleic acid food sources in our study population.

Dataset Information

Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial.

Publications

Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial.

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