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Moms fit 2 fight: Rationale, design, and analysis plan of a behavioral weight management intervention for pregnant and postpartum women in the U.S. military.
Fahey, MC, Wayne Talcott, G, Cox Bauer, CM, Bursac, Z, Gladney, L, Hare, ME, Harvey, J, Little, M, McCullough, D, Hryshko-Mullen, AS, et al
Contemporary clinical trials. 2018;:46-54
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Association of Low-Fat Dietary Pattern With Breast Cancer Overall Survival: A Secondary Analysis of the Women's Health Initiative Randomized Clinical Trial.
Chlebowski, RT, Aragaki, AK, Anderson, GL, Simon, MS, Manson, JE, Neuhouser, ML, Pan, K, Stefanic, ML, Rohan, TE, Lane, D, et al
JAMA oncology. 2018;(10):e181212
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Abstract
IMPORTANCE In a randomized clinical trial, a low-fat eating pattern was associated with lower risk of death after breast cancer. However, the extent to which results were driven by dietary influence on survival after breast cancer diagnosis was unknown. OBJECTIVE To determine the association of a low-fat dietary pattern with breast cancer overall survival (breast cancer followed by death from any cause measured from cancer diagnosis). DESIGN, SETTING, AND PARTICIPANTS This is a secondary analysis of the Women's Health Initiative randomized clinical trial that was conducted at 40 US clinical centers enrolling participants from 1993 through 1998. Participants were 48 835 postmenopausal women with no previous breast cancer and dietary fat intake of greater than 32% by food frequency questionnaire. INTERVENTIONS Participants were randomized to a dietary intervention group (40%; n = 19 541) with goals to reduce fat intake to 20% of energy and increase fruit, vegetable, and grain intake or a usual-diet comparison group (60%; n = 29 294). Dietary group participants with incident breast cancers continued to participate in subsequent dietary intervention activities. MAIN OUTCOMES AND MEASURES Breast cancer overall survival for incident breast cancers diagnosed during the 8.5-year (median) dietary intervention, examined in post hoc analyses after 11.5 years (median) postdiagnosis follow-up. RESULTS Of 1764 women diagnosed with breast cancer during the dietary intervention period, mean (SD) age at screening was 62.7 (6.7) years and age at diagnosis was 67.6 (6.9) years. With 516 total deaths, breast cancer overall survival was significantly greater for women in the dietary intervention group than in the usual-diet comparison group (10-year survival of 82% and 78%, respectively; hazard ratio [HR], 0.78; 95% CI, 0.65-0.94; P = .01). In the dietary group there were fewer deaths from breast cancer (68 vs 120; HR, 0.86; 95% CI, 0.64-1.17), other cancers (36 vs 65; HR, 0.76; 95% CI, 0.50-1.17), and cardiovascular disease (27 vs 64; HR, 0.62; 95% CI, 0.39-0.99). CONCLUSIONS AND RELEVANCE In women who received a diagnosis of breast cancer during the dietary intervention period, those in the dietary group had increased overall survival. The increase is due, in part, to better survival from several causes of death. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00000611.
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Patients' and therapists' experiences with a new treatment programme for eating disorders that combines physical exercise and dietary therapy: the PED-t trial. A qualitative study protocol.
Pettersen, G, Rosenvinge, JH, Bakland, M, Wynn, R, Mathisen, TF, Sundgot-Borgen, J
BMJ open. 2018;(1):e018708
Abstract
INTRODUCTION Women with bulimia nervosa and binge eating disorder often suffer for many years before they seek professional help. Evidence-based treatments like cognitive-behavioural therapy (CBT) might be poorly accessible, and about 50% of those who receive CBT respond to it. Such outcome may reflect the heterogeneous nature of eating disorders, and addressing this heterogeneity calls for expanding the portfolio of treatment options. In particular, it is important to explore such options' acceptability, tolerability and affordability expressed through experiences with the treatment. This protocol outlines the rationale and design of a qualitative study. It captures experiences from patients and therapists who were involved in a randomised controlled trial (RCT) exploring the efficacy of a new group-based treatment programme combining physical exercise and dietary therapy. METHODS AND ANALYSIS 15 patients with bulimia nervosa or binge eating disorder, 10 therapists (physical trainers and dietitians) and 6-10 patients who dropped out of the RCT will be semistructurally interviewed. All interviews will be analysed using a systematic text condensation approach. ETHICS AND DISSEMINATION Results will be presented in peer-reviewed international journals, and at relevant international conferences. Key findings will be available to study participants as well as to patient organisations and health authorities. The overall study meets the intent and requirements of the Health Research Act and the Declaration of Helsinki. It is approved by the regional committee for medical research ethics (2013/1871). TRIAL REGISTRATION NUMBER NCT02079935; Pre-results.
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Dietary interventions to prevent and manage diabetes in worksite settings: a meta-analysis.
Shrestha, A, Karmacharya, BM, Khudyakov, P, Weber, MB, Spiegelman, D
Journal of occupational health. 2018;(1):31-45
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OBJECTIVES The translation of lifestyle intervention to improve glucose tolerance into the workplace has been rare. The objective of this meta-analysis is to summarize the evidence for the effectiveness of dietary interventions in worksite settings on lowering blood sugar levels. METHODS We searched for studies in PubMed, Embase, Econlit, Ovid, Cochrane, Web of Science, and Cumulative Index to Nursing and Allied Health Literature. Search terms were as follows: (1) Exposure-based: nutrition/diet/dietary intervention/health promotion/primary prevention/health behavior/health education/food /program evaluation; (2) Outcome-based: diabetes/hyperglycemia/glucose/HbA1c/glycated hemoglobin; and (3) Setting-based: workplace/worksite/occupational/industry/job/employee. We manually searched review articles and reference lists of articles identified from 1969 to December 2016. We tested for between-studies heterogeneity and calculated the pooled effect sizes for changes in HbA1c (%) and fasting glucose (mg/dl) using random effect models for meta-analysis in 2016. RESULTS A total of 17 articles out of 1663 initially selected articles were included in the meta-analysis. With a random-effects model, worksite dietary interventions led to a pooled -0.18% (95% CI, -0.29 to -0.06; P<0.001) difference in HbA1c. With the random-effects model, the interventions resulted in 2.60 mg/dl lower fasting glucose with borderline significance (95% CI: -5.27 to 0.08, P=0.06). In the multivariate meta-regression model, the interventions with high percent of female participants and that used the intervention directly delivered to individuals, rather the environment changes, were associated with more effective interventions. CONCLUSION Workplace dietary interventions can improve HbA1c. The effects were larger for the interventions with greater number of female participants and with individual-level interventions.
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Are Preschoolers Meeting the Mark? Comparing the Dietary, Activity, and Sleep Behaviors of Preschoolers With Obesity to National Recommendations.
Odar Stough, C, McCullough, MB, Robson, SL, Bolling, C, Spear Filigno, S, Kichler, JC, Zion, C, Clifford, LM, Simon, SL, Ittenbach, RF, et al
Journal of pediatric psychology. 2018;(4):452-463
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OBJECTIVE National health organizations and expert committees have issued recommendations for health behaviors related to obesity risk. Behavioral and family-based weight management interventions for preschoolers often target improving adherence to these recommendations, but it is unknown how the health behaviors of preschoolers with obesity enrolled in weight control treatments (WCTs) compare with these guidelines. In this study, the dietary intake, activity, and sleep behaviors of preschoolers with obesity enrolled in a family-based behavioral WCT are described and compared with national health behavior recommendations. METHODS Health behaviors of 151 preschoolers with obesity (M age = 4.60, SD = 0.93) enrolled in a clinical trial of a weight management program were measured at baseline through caregiver-report questionnaires, three 24-hr dietary recalls, and accelerometers. RESULTS In total, 70% of the sample exceeded daily caloric recommendations, only 10 and 5% met recommendations for fruit and vegetable intake, respectively, and only 30% met the recommendation of consuming no sugar-sweetened beverages. The majority of the sample met the daily recommendations for 60 min of moderate-to-vigorous activity (80%), < 2 hr of screen time (68%), and sleep duration (70%). CONCLUSIONS Behavioral weight management interventions for preschoolers with obesity should target the health behaviors where children are not meeting recommendations.
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Dietary interventions in the treatment of metabolic syndrome as a cardiovascular disease risk-inducing factor. A review.
Mandecka, A, Regulska-Ilow, B
Roczniki Panstwowego Zakladu Higieny. 2018;(3):227-233
Abstract
Metabolic syndrome (MetS) is a concept which refers to a simultaneous occurrence of clinically significant cardiovascular disease (CVD) risk factors that increase the risk of atherosclerosis and type 2 diabetes as well as their vascular complications. The metabolic syndrome is a complex disorder, therefore its treatment should be multifactorial and intensive. MetS occurs due to a combination of genetic and environmental factors. Each of MetS components is a well-known risk factor of atherosclerosis. Such modifications to the lifestyle as increasing physical activity, introducing a well-balanced diet and reducing the body mass are associated with reduced occurrence of MetS and its individual components. It is necessary to implement proper dietary processes, a physical training program and pharmacological treatment. The treatment of MetS should begin with weight loss, which affects the occurrence of abdominal obesity, as well as increased physical activity, leading to an increased tissue sensitivity to insulin. It is recommended to introduce a low-energy, individually balanced diet that will lead to a 7-10% weight loss over the course of 6-12 months. Patients are also advised to quit smoking and limit the consumption of salt and alcohol.
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Real-World Effectiveness of a Medically Supervised Weight Management Program in a Large Integrated Health Care Delivery System: Five-Year Outcomes.
Krishnaswami, A, Ashok, R, Sidney, S, Okimura, M, Kramer, B, Hogan, L, Sorel, M, Pruitt, S, Smith, W
The Permanente journal. 2018;:17-082
Abstract
CONTEXT There are insufficient data on the long-term, nonsurgical, nonpharmacologic treatment of obesity. OBJECTIVE To determine changes in weight over 5 years in participants enrolled between April 1, 2007, and December 31, 2014, in a medically supervised weight management program at Kaiser Permanente Northern California Medical Centers. The program consisted of 3 phases: Complete meal replacement for 16 weeks; transition phase, 17 to 29 weeks; and lifestyle maintenance phase, 30 to 82 weeks. DESIGN Retrospective observational study of 10,693 participants (2777 available for analysis at 5 years); no comparator group. MAIN OUTCOME MEASURES Average change in weight from baseline to follow-up. RESULTS Average age was 51.1 (standard deviation = 12.4) years, and 72.8% were women. Average baseline weight in the entire cohort was 112.9 kg (standard error [SE] = 0.23). Weight (kg) significantly changed over time: 4 months, -17.3 (SE = 0.12); 1 year, -14.2 (SE = 0.12); 2 years, -8.6 (SE = 0.14); 3 years, -6.9 (SE = 0.17); 4 years, -6.5 (SE = 0.16), and 5 years, -6.4 (SE = 0.29); p < 0.0001). In those with 5-year follow-up, weight loss between 5.0 and 9.9% below baseline occurred in 16.3% (SE = 0.004, 95% CI = 15.3% - 17.2%) and weight loss of 10.0% or more of baseline occurred in 35.2% (SE = 0.01, 95% CI = 33.6% - 36.7%). CONCLUSION The average weight change of obese adults who participated in a medically supervised weight management program, with available 5-year data, was a statistically and clinically significant 5.8% weight loss from baseline.
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Volatile Organic Compounds in Feces Associate With Response to Dietary Intervention in Patients With Irritable Bowel Syndrome.
Rossi, M, Aggio, R, Staudacher, HM, Lomer, MC, Lindsay, JO, Irving, P, Probert, C, Whelan, K
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2018;(3):385-391.e1
Abstract
BACKGROUND & AIMS Dietary interventions are effective in management of patients with irritable bowel syndrome (IBS), although responses vary. We investigated whether fecal levels of volatile organic compounds (VOCs) associate with response to dietary interventions in patients with IBS. METHODS Adults who fulfilled the Rome III criteria for IBS were recruited to a 2x2 factorial randomized controlled trial. Patients were randomly assigned to a group counselled to follow a diet low in fructans, galacto-oligosaccharides, lactose, fructose, and polyols (low-FODMAP diet, n = 46) or a group that received placebo dietary advice (sham diet, n = 47) for 4 weeks. Patients from each group were also given either a multi-strain probiotic or placebo supplement. Response was defined as a reduction of 50 points or more on the validated IBS symptom scoring system. Fecal samples were collected from participants at baseline and end of the 4-week study period; VOCs were analyzed by a gas-chromatography sensor device. VOC profiles were determined using a pipeline involving wavelet transformation followed by feature selection based on random forest. A partial least squares classifier was constructed to classify VOC profiles by response and accuracies were determined using 10-fold cross-validation. RESULTS Data from 93 patients who completed the study (63 female) were used in the final analysis. More patients responded to the low-FODMAP diet (37/46, 80%) than the sham diet (21/47, 45%) (P < .001), but there was no difference in response between patients given the probiotic (31/49, 63%) vs the placebo (27/44, 61%) (P = .850), with no interaction between the diet and supplement interventions. At baseline, VOC profiles contained 15 features that classified response to the low-FODMAP diet with a mean accuracy of 97% (95% CI, 96%-99%) and 10 features that classified response to probiotic with a mean accuracy of 89% (95% CI, 86%-92%). End of treatment models achieved similar predictive powers and accuracies. CONCLUSION Fecal VOC profiling is a low cost, non-invasive tool that might be used to predict responses of patients with IBS to low-FODMAP diet and probiotics and identify their mechanisms of action. ISRCTN registry no: 02275221.
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Lifestyle intervention for morbid obesity: effects on liver steatosis, inflammation, and fibrosis.
Hohenester, S, Christiansen, S, Nagel, J, Wimmer, R, Artmann, R, Denk, G, Bischoff, M, Bischoff, G, Rust, C
American journal of physiology. Gastrointestinal and liver physiology. 2018;(3):G329-G338
Abstract
The prevalence of obesity-related nonalcoholic fatty liver disease (NAFLD) is rising. NAFLD may result in nonalcoholic steatohepatitis (NASH), progressing to liver cirrhosis. Weight loss is recommended to treat obesity-related NASH. Lifestyle intervention may improve NASH; however, pertinent trials have so far focused on overweight patients, whereas patients with obesity are at highest risk of developing NAFLD. Furthermore, reports of effects on liver fibrosis are scarce. We evaluated the effect of lifestyle intervention on NAFLD in a real-life cohort of morbidly obese patients. In our observational study, 152 patients underwent lifestyle intervention, with a follow-up of 52 weeks. Noninvasive measures of obesity, metabolic syndrome, liver steatosis, liver damage, and liver fibrosis were analyzed. Treatment response in terms of weight loss was achieved in 85.1% of patients. Dysglycemia and dyslipidemia improved. The proportion of patients with fatty liver dropped from 98.1 to 54.3% ( P < 0.001). Weight loss >10% was associated with better treatment response ( P = 0.0009). Prevalence of abnormal serum transaminases fell from 81.0 to 50.5% ( P < 0.001). The proportion fibrotic patients, as determined by the NAFLD fibrosis score, dropped from 11.8 to 0% ( P < 0.05). Low serum levels of adiponectin correlated with degree of liver damage, i.e., serum liver transaminases ( r = -0,32, P < 0.05). Serum levels of adiponectin improved with intervention. In conclusion, lifestyle intervention effectively targeted obesity and the metabolic syndrome. Liver steatosis, damage and fibrosis were ameliorated in this real-life cohort of morbidly obese patients, mediated in part by changes in the adipokine profile. Patients with weight loss of >10% seemed to benefit most. NEW & NOTEWORTHY We demonstrate new evidence that lifestyle intervention is effective in treating NAFLD in the important group of patients with (morbid) obesity. Although current guidelines on the therapy of NASH recommend weight loss of 5-7%, weight reduction >10% may be favorable in morbid obesity. Serum levels of adipokines correlate with liver damage, which is indicative of their pathogenetic importance in human NASH. Our study adds to the limited body of evidence that NAFLD-associated liver fibrosis may resolve with lifestyle intervention.
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Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial.
Mallewa, J, Szubert, AJ, Mugyenyi, P, Chidziva, E, Thomason, MJ, Chepkorir, P, Abongomera, G, Baleeta, K, Etyang, A, Warambwa, C, et al
The lancet. HIV. 2018;(5):e231-e240
Abstract
BACKGROUND In sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only. METHODS We did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5-12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16-18 kg/m2 or BMI-for-age Z scores <-3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374). FINDINGS Between June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0-13·1) participants allocated to RUSF and 92 (10·3%, 8·5-12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79-1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45). INTERPRETATION In severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present. FUNDING Joint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust).