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Adherence to Dietary Recommendations after One Year of Intervention in Breast Cancer Women: The DIANA-5 Trial.
Bruno, E, Krogh, V, Gargano, G, Grioni, S, Bellegotti, M, Venturelli, E, Panico, S, Santucci de Magistris, M, Bonanni, B, Zagallo, E, et al
Nutrients. 2021;(9)
Abstract
The Diet and Androgen-5 (DIANA-5) trial aimed at testing whether a dietary change based on the Mediterranean diet and on macrobiotic principles can reduce the incidence of breast cancer (BC)-related events. We analyzed the adherence to the DIANA-5 dietary recommendations by randomization group after 1 year of intervention. We evaluated the association between dietary adherence and changes in body weight and metabolic syndrome (MS) parameters. BC women aged 35-70 years were eligible. After the baseline examinations, women were randomized into an intervention group (IG) or a control group (CG). A total of 1344 BC women (689 IG and 655 CG) concluded the first year of dietary intervention. IG showed greater anthropometric and metabolic improvements compared to CG. These changes were significantly associated with increased adherence to the dietary recommendations. Women who increased recommended foods consumption or reduced discouraged foods consumption showed an Odds Ratio (OR) of 1.37 (0.70-2.67) and 2.02 (1.03-3.98) to improve three or more MS parameters. Moreover, women in the higher category of dietary change showed a four times higher OR of reducing body weight compared to the lower category (p < 0.001). The DIANA-5 dietary intervention is effective in reducing body weight and MS parameters.
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Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial.
Reeves, MM, Terranova, CO, Winkler, EAH, McCarthy, N, Hickman, IJ, Ware, RS, Lawler, SP, Eakin, EG, Demark-Wahnefried, W
Nutrients. 2021;(11)
Abstract
Limited evidence exists on the effects of weight loss on chronic disease risk and patient-reported outcomes in breast cancer survivors. Breast cancer survivors (stage I-III; body mass index 25-45 kg/m2) were randomized to a 12-month, remotely delivered (22 telephone calls, mailed material, optional text messages) weight loss (diet and physical activity) intervention (n = 79) or usual care (n = 80). Weight loss (primary outcome), body composition, metabolic syndrome risk score and components, quality of life, fatigue, musculoskeletal pain, menopausal symptoms, fear of recurrence, and body image were assessed at baseline, 6 months, 12 months (primary endpoint), and 18 months. Participants were 55 ± 9 years and 10.7 ± 5.0 months post-diagnosis; retention was 81.8% (12 months) and 80.5% (18 months). At 12-months, intervention participants had significantly greater improvements in weight (-4.5% [95%CI: -6.5, -2.5]; p < 0.001), fat mass (-3.3 kg [-4.8, -1.9]; p < 0.001), metabolic syndrome risk score (-0.19 [-0.32, -0.05]; p = 0.006), waist circumference (-3.2 cm [-5.5, -0.9]; p = 0.007), fasting plasma glucose (-0.23 mmol/L [-0.44, -0.02]; p = 0.032), physical quality of life (2.7 [0.7, 4.6]; p = 0.007; Cohen's effect size (d) = 0.40), musculoskeletal pain (-0.5 [-0.8, -0.2]; p = 0.003; d = 0.49), and body image (-0.2 [-0.4, -0.0]; p = 0.030; d = 0.31) than usual care. At 18 months, effects on weight, adiposity, and metabolic syndrome risk scores were sustained; however, significant reductions in lean mass were observed (-1.1 kg [-1.7, -0.4]; p < 0.001). This intervention led to sustained improvements in adiposity and metabolic syndrome risk.
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Cardiometabolic Benefits of a Weight-Loss Mediterranean Diet/Lifestyle Intervention in Patients with Obstructive Sleep Apnea: The "MIMOSA" Randomized Clinical Trial.
Georgoulis, M, Yiannakouris, N, Kechribari, I, Lamprou, K, Perraki, E, Vagiakis, E, Kontogianni, MD
Nutrients. 2020;(6)
Abstract
Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), its cardiometabolic benefits are questionable. Our aim was to explore whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care leads to greater cardiometabolic improvements compared with standard care alone. We randomly assigned 187 adult, overweight, polysomnography-diagnosed moderate-to-severe OSA patients to a standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All three groups were prescribed with CPAP. Additionally, the SCG only received brief written healthy lifestyle advice, while intervention arms were subjected to a six-month weight-loss behavioral intervention based on the Mediterranean diet. The MLG also received guidance for improving physical activity and sleep habits. Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all p < 0.05). The age-, sex-, baseline- and CPAP use-adjusted relative risk (95% confidence interval) of metabolic syndrome was 0.58 (0.34-0.99) for the MDG and 0.30 (0.17-0.52) for the MLG compared to the SCG. The MLG additionally presented a lower relative risk of metabolic syndrome compared to the MDG (0.52 (0.30-0.89)). After further adjustment for body-weight change, a lower relative risk of metabolic syndrome was still evident for the MLG compared to the SCG. In conclusion, although standard care alone does not improve OSA patients' cardiometabolic profile, its combination with a weight-loss Mediterranean diet/lifestyle intervention leads to significant cardiometabolic benefits.
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Effect of weight loss on neutrophil resolvins in the metabolic syndrome.
Barden, A, Shinde, S, Tsai, IJ, Croft, KD, Beilin, LJ, Puddey, IB, Mori, TA
Prostaglandins, leukotrienes, and essential fatty acids. 2019;:25-29
Abstract
BACKGROUND Non-resolving inflammation associates with obesity and insulin resistance, and may be dependent on the balance of inflammatory substances and specialised pro-resolving mediators of inflammation (SPM) that act to halt the inflammatory response. This controlled trial examined the effect of weight loss on neutrophil synthesis of SPM in volunteers with the metabolic syndrome (MetS). METHODS Volunteers with MetS (n = 42) were matched for age and gender and randomly assigned to a 12-wk weight loss program followed by 4-wk weight stabilization or a 16-wk weight maintenance program. At baseline and 16 weeks, isolated neutrophils were stimulated with calcium ionophore and the released SPM were measured by LC-MS/MS. RESULTS At baseline the SPM resolvin (Rv) E1, 18R-RvE3, RvD2 and Maresin-1 (MaR-1) were detected from stimulated neutrophils. The concentration of released RvE1 was at least 6-fold that of other detected SPM. Weight loss of 4.7 ± 0.8 kg, led to a 2-fold increase in RvE1, P = 0.013, relative to the weight maintenance group. The increase in RvE1 after weight loss was related to, but independent of leukotriene B4. CONCLUSION Following weight loss, human neutrophils from individuals with the metabolic syndrome are capable of releasing larger amounts of RvE1 upon stimulation.
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Effect of a 24-week weight management program on serum leptin level in correlation to anthropometric measures in obese female: A randomized controlled clinical trial.
Rashad, NM, Sayed, SE, Sherif, MH, Sitohy, MZ
Diabetes & metabolic syndrome. 2019;(3):2230-2235
Abstract
BACKGROUND Obesity is a major contributor to preventable disease and death across the globe. Obesity is complex. Although its risk factors are myriad and compounding, there is an urgent need for a deeper understanding of the way risk factors interact with each other. Leptin is a peptide regulates food intake and body weight. However, the notion of leptin as an anti-obesity hormone was called into question because obesity is typically associated with high leptin levels and not leptin deficiency thus, we aimed to measure leptin levels in obese female in correlation to anthropometric measures and to evaluate the impact of weight loss on its level and metabolic parameters. SUBJECT AND METHODS case-control study enrolled 40 control groups, 50 obese women. We measured anthropometric measures BMI, Waist/hip ratio (WHR). Fat mass index (FMI%) and free fat mass index (FFMI%) were assessed by dual energy X-Ray absorptiometry (DEXA) The serum levels of leptin were measured by ELISA. RESULTS Our results revealed that serum leptin levels were higher in obese women compared to controls. Moreover, it was positively correlated to anthropometric measures, glycemic and lipid profile. Linear regression analysis revealed that BMI was the main independent studied parameters associated with serum leptin level among other clinical and laboratory biomarkers. Interestingly, after 12 weeks of following the Mediterranean diet (MD)-based weight loss program, serum leptin levels were decreased. Logistic regression analysis was performed to detect the main predictors' biomarkers associated with weight loss among obese women. We found that serum leptin and FMI% were an independent predictor of response with odds ratios of 1.69 and 1.64 respectively (P < 0.001), Receiver operating characteristic analyses revealed that the AUC of serum leptin in discriminating obese women from lean ones was 0.893 (95% CI = 0.815-0.917) with sensitivity = 90%, specificity = 96%, and the cutoff values was 36.32 ng/ml. CONCLUSION Serum leptin could be a valuable diagnostic marker of obesity and its comorbidities. Moreover, significant weight loss leads to decrease serum leptin levels and improvement of glycemic and lipid profiles.
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Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone.
Yackobovitch-Gavan, M, Wolf Linhard, D, Nagelberg, N, Poraz, I, Shalitin, S, Phillip, M, Meyerovitch, J
Pediatric obesity. 2018;(11):647-655
Abstract
OBJECTIVES The study aims to assess the effects of family-based interventions targeted to parents only or to parents-and-child for the prevention and treatment of childhood obesity. METHOD An open-label randomized study was conducted in 247 children (166 girls, 5-11 years) with body mass index (BMI) in the 85-98th percentile. Participants were allocated to three groups: parents-only (n = 89), parents-and-child (n = 84) and follow-up alone (n = 74). The intervention consisted of 12 once-weekly meetings with a dietician and psychologist. All children were followed for 2 years. Changes in anthropometric, clinical and lifestyle outcomes were assessed. RESULTS The 3-month intervention was completed by 58 (65.2%) in the parents-only, 61 (72.6%) in the parents-child and 49 (66.2%) in the control group (P = .554). BMI-standard deviation score (SDS) decreased from baseline to 3 months in both intervention groups (parents-only: from 1.74 ± 0.31 to 1.66 ± 0.36, P < .001; parents-child, 1.83 ± 0.33 to 1.76 ± 0.36, P = .012), with no significant change in the controls (1.73 ± 0.32 to 1.70 ± 0.31, P = .301). The 2-year follow-up was completed by 45 in each of the intervention groups (50.5% and 53.5%, respectively) and 37 controls (50%) (P = .896). Compared with baseline, only the parents-child group showed a significant decrease in BMI-SDS (1.56 ± 0.46, P = .006). The rate of children who met the criteria for metabolic syndrome tended to drop from 6.0% at baseline (14/232) to 1.5% at 3 months (12/137) (P = .109), with no significant between-group differences in the rate of metabolic syndrome at baseline or at completion of the intervention. CONCLUSIONS An intervention programme that focuses on both parents and children was found to have positive short-term and long-term effects on BMI-SDS.
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Community Weight Loss to Combat Obesity and Disability in At-Risk Older Adults.
Rejeski, WJ, Ambrosius, WT, Burdette, JH, Walkup, MP, Marsh, AP
The journals of gerontology. Series A, Biological sciences and medical sciences. 2017;(11):1547-1553
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Abstract
BACKGROUND Among older, overweight, and obese adults with either cardiovascular disease or the metabolic syndrome, reduced mobility and loss of leg strength are important risk factors for morbidity, disability, and mortality. It is unclear whether community-based approaches to weight loss may be an effective solution to this public health challenge. METHODS An 18-month three-site, randomized controlled trial conducted by YMCA staff, with blinded assessors, enrolled 249 older, overweight, and obese adults with either cardiovascular disease or metabolic syndrome with randomization to three interventions: weight loss alone (WL), weight loss + aerobic training (WL + AT), and weight loss + resistance training (WT + RT). The dual primary outcomes were 400-m walk time in seconds and knee extensor strength in Newton meters. RESULTS All groups lost weight from baseline: average baseline adjusted change of -6.1% (95% confidence interval [CI]: -7.5 to -4.7) for WL only, -8.6% (95% CI: -10.0 to -7.2) for WL + AT, and -9.7% (95% CI: -11.1 to -8.4) for WL + RT. Combined, the two physical activity + WL training groups had greater improvement in walk time than WL alone (mean difference 16.9 seconds [95% CI: 9.7 to 24.0], p < .0001). Baseline adjusted change in knee extensor strength was no greater with WL + RT than WL + AT (mean difference -3.6 Nm [95% CI: -7.5 to 0.3], p = .07). CONCLUSIONS At risk, older, overweight and obese adults can achieve clinically significant reductions in body weight with community-based weight loss programs. The change in percent weight loss and improvements in mobility are significantly enhanced when either RT or AT is combined with dietary WL.
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Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.
Daubenmier, J, Moran, PJ, Kristeller, J, Acree, M, Bacchetti, P, Kemeny, ME, Dallman, M, Lustig, RH, Grunfeld, C, Nixon, DF, et al
Obesity (Silver Spring, Md.). 2016;(4):794-804
Abstract
OBJECTIVE To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components. METHODS In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change. RESULTS Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein. CONCLUSIONS Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study.
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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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Recruitment for a Diabetes Prevention Program translation effort in a worksite setting.
Taradash, J, Kramer, M, Molenaar, D, Arena, V, Vanderwood, K, Kriska, AM
Contemporary clinical trials. 2015;:204-10
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BACKGROUND The success of the Diabetes Prevention Program (DPP) lifestyle intervention has led to community-based translation efforts in a variety of settings. One community setting which holds promise for the delivery of prevention intervention is the worksite; however, information regarding recruitment in this setting is limited. The current effort describes the initial processes surrounding provision of an adapted DPP lifestyle intervention at a corporate worksite. METHODS Investigators and key management at the worksite collaborated to develop and implement a recruitment plan for the intervention focusing on 1) in-person onsite activities and 2) implementation of a variety of media recruitment tools and methods. RESULTS Adult, non-diabetic overweight/obese employees and family members with pre-diabetes and/or the metabolic syndrome were eligible for the study. Telephone pre-screening was completed for 176 individuals resulting in 171 eligible for onsite screening. Of that number, 160 completed onsite screening, 107 met eligibility criteria, and 89 enrolled in the study. Support from worksite leadership, an invested worksite planning team and a solid recruitment plan consisting of multiple strategies were identified as crucial elements of this effective workplace recruitment effort. CONCLUSION A worksite team successfully developed and implemented a recruitment plan using existing mechanisms appropriate to that worksite in order to identify and enroll eligible individuals. The results of this effort indicate that employee recruitment in a worksite setting is feasible as the first step in offering onsite behavioral lifestyle intervention programs as part of a widespread dissemination plan to prevent diabetes and lower risk for cardiovascular disease.