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Impact of guideline-recommended dietitian assessments on weight gain in infants with cystic fibrosis.
Ong, T, Onchiri, FM, Britto, MT, Heltshe, SL, Kessler, LG, Seid, M, Ramsey, BW
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2022;(1):115-122
Abstract
BACKGROUND Cystic fibrosis (CF)-specialized nutrition care strives to meet normal infant growth, but the relationship of dietitian assessments to weight outcomes is unknown. We characterize nutrition management for inadequate weight gain and assess association of dietitian assessments and center-level weight-for-age Z-scores (WAZ). METHODS We used encounter data from 226 infants across 28 US CF Centers from the Baby Observational Nutritional study between January 2012 through December 2017. We identified dietitian assessments and consensus guideline-recommended responses to inadequate weight gain: calorie increases, pancreatic enzyme replacement therapy (PERT) increases, or shortened time to next visit. We compared center assessments by funnel plot and summarize median WAZ by center. RESULTS Of 2,527 visits, 808 (32%) visits had identified inadequate weight gain, distributed in 216 infants. Assessments occurred in 1953 visits (77%), but varied widely between centers (range 17% - 98%). For inadequate weight gain, most and least common responses were calorie increase (64%) and PERT increase (21%). Funnel plot analysis identified 4 high-performers for frequent dietitian assessments (range 92% - 98%) and 4 under-performers (range 17% - 56%). High-performers treated inadequate weight gain more often with adequate calories (24/30, 80% v. 12/23, 52%) and closer follow up (104/164, 63% v. 60/120, 49%) compared to under-performers. Three of 4 high-performing sites met center nutrition goals for positive median WAZ at 2 years old unlike 3 under-performers (WAZHigh 0.33 v. WAZLow -0.15), despite similar patient characteristics. CONCLUSION We characterized multicenter variation in dietitian assessments, identifying opportunities to improve care delivery to target early nutrition outcomes.
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Nutritional counseling frequency and baseline food pattern predict implementation of a high-protein and high-polyunsaturated fatty acid dietary pattern: 1-year results of the randomized NutriAct trial.
Pletsch-Borba, L, Wernicke, C, Apostolopoulou, K, Spira, D, Pohrt, A, Hornemann, S, Gerbracht, C, Pfeiffer, AFH, Spranger, J, Mai, K
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5457-5466
Abstract
BACKGROUND & AIMS NutriAct is a 36-month randomized controlled multi-center trial designed to analyze the effects of a food pattern focusing on a high-protein and high-unsaturated fatty acids (UFA) intake on healthy aging. We aimed to determine factors associated with a successful modulation of dietary pattern after 12 months in elderly participants. METHODS 502 participants were randomized into either usual care control group including dietary recommendations of the German Nutrition Society (DGE) or an intervention group, which used supplementation of rapeseed oil and specifically designed foods as well as repetitive advices to implement a food pattern based on high intake of predominantly plant proteins, UFA and fiber (NutriAct pattern). Food intake was repeatedly assessed by 3-day food records at months 0, 3, 6 and 12. Linear regression models were used to investigate determinants of basal food intake and modulation of dietary pattern during the intervention. RESULTS Food records of 242 intervention and 246 control participants (median age 66 y, 37% males) were available at baseline and were included. At baseline, high BMI was related to higher protein and saturated fatty acids and lower fiber intake. The intervention resulted in higher intake of protein, mono- and polyunsaturated fatty acids (MUFA and PUFA) and fiber, and lower carbohydrate and saturated fatty acid consumption (all p < 0.001). While individuals who were already at baseline closer to the NutriAct pattern also achieved a diet closer to the proposed pattern at month 12, the strongest absolute changes (%E) of dietary behavior were seen in those with dietary patterns further away from the proposed pattern at baseline. Attendance to nutritional sessions was crucial to change MUFA, PUFA, fiber and carbohydrate intake. CONCLUSIONS A successful modification of dietary pattern was achieved by the performed intervention within 12 months. Baseline dietary habits and attendance to nutritional sessions were substantial determinants predicting changes in dietary pattern. CLINICAL TRIAL REGISTRATION The trial was registered at German Clinical Trials Register (drks.de) as DRKS00010049.
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Effect of Individual Nutrition Therapy and Exercise Regime on Gait Speed, Physical Function, Strength and Balance, Body Composition, Energy and Protein, in Injured, Vulnerable Elderly: A Multisite Randomized Controlled Trial (INTERACTIVE).
Han, CY, Crotty, M, Thomas, S, Cameron, ID, Whitehead, C, Kurrle, S, Mackintosh, S, Miller, M
Nutrients. 2021;(9)
Abstract
It is imperative that the surgical treatment of hip fractures is followed up with rehabilitation to enhance recovery and quality of life. This randomized controlled trial aimed to determine if an individualised, combined exercise-nutrition intervention significantly improved health outcomes in older adults, after proximal femoral fracture. We commenced the community extended therapy while in hospital, within two weeks post-surgery. The primary outcome was gait speed and secondary outcomes included physical function, strength and balance, body composition, energy and protein intake. Eighty-six and 89 participants were randomized into six months individualised exercise and nutrition intervention and attention-control groups, respectively. There were no statistically significant differences in gait speed between the groups at six and 12 months. There were no major differences between groups with respect to the secondary outcomes, except estimated energy and protein intake. This may be explained by the sample size achieved. Participants in the intervention group had greater increment in energy (235 kcal; 95% CI, 95 to 375; p = 0.01) and protein intake (9.1 g; 95% CI, 1.5 to 16.8; p = 0.02), compared with those in the control group at six months but not significant at 12 months. This study has demonstrated that providing early, combined exercise and nutrition therapy can improve dietary energy and protein intake in older adults with hip fractures.
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COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial.
Annweiler, C, Beaudenon, M, Gautier, J, Simon, R, Dubée, V, Gonsard, J, Parot-Schinkel, E, ,
Trials. 2020;(1):1031
Abstract
BACKGROUND With the lack of effective therapy, chemoprevention, and vaccination against SARS-CoV-2, focusing on the immediate repurposing of existing drugs gives hope of curbing the COVID-19 pandemic. A recent unbiased genomics-guided tracing of the SARS-CoV-2 targets in human cells identified vitamin D among the three top-scoring molecules manifesting potential infection mitigation patterns. Growing pre-clinical and epidemiological observational data support this assumption. We hypothesized that vitamin D supplementation may improve the prognosis of COVID-19. The aim of this trial is to compare the effect of a single oral high dose of cholecalciferol versus a single oral standard dose on all-cause 14-day mortality rate in COVID-19 older adults at higher risk of worsening. METHODS The COVIT-TRIAL study is an open-label, multicenter, randomized controlled superiority trial. Patients aged ≥ 65 years with COVID-19 (diagnosed within the preceding 3 days with RT-PCR and/or chest CT scan) and at least one worsening risk factor at the time of inclusion (i.e., age ≥ 75 years, or SpO2 ≤ 94% in room air, or PaO2/FiO2 ≤ 300 mmHg), having no contraindications to vitamin D supplementation, and having received no vitamin D supplementation > 800 IU/day during the preceding month are recruited. Participants are randomized either to high-dose cholecalciferol (two 200,000 IU drinking vials at once on the day of inclusion) or to standard-dose cholecalciferol (one 50,000 IU drinking vial on the day of inclusion). Two hundred sixty participants are recruited and followed up for 28 days. The primary outcome measure is all-cause mortality within 14 days of inclusion. Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale for COVID-19, and the between-group comparison of safety. These outcomes are assessed at baseline, day 14, and day 28, together with the serum concentrations of 25(OH)D, creatinine, calcium, and albumin at baseline and day 7. DISCUSSION COVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments. TRIAL REGISTRATION ClinicalTrials.gov NCT04344041 . Registered on 14 April 2020 TRIAL STATUS Recruiting. Recruitment is expected to be completed in April 2021.
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Improving feeding and growth of HIV-positive children through nutrition training of frontline health workers in Tanga, Tanzania.
Sunguya, BF, Mlunde, LB, Urassa, DP, Poudel, KC, Ubuguyu, OS, Mkopi, NP, Leyna, GH, Kessy, AT, Nanishi, K, Shibanuma, A, et al
BMC pediatrics. 2017;(1):94
Abstract
BACKGROUND Nutrition training can boost competence of health workers to improve children's feeding practices. In this way, child undernutrition can be ameliorated in general populations. However, evidence is lacking on efficacy of such interventions among Human Immunodeficiency Virus (HIV)-positive children. We aimed to examine the efficacy of a nutrition training intervention to improve midlevel providers' (MLPs) nutrition knowledge and feeding practices and the nutrition statuses of HIV-positive children in Tanga, Tanzania. METHODS This cluster-randomized controlled trial was conducted in 16 out of 32 care and treatment centers (CTCs) in Tanga. Eight CTCs were assigned to the intervention arm and a total of 16 MLPs received nutrition training and provided nutrition counseling and care to caregivers of HIV-positive children. A total of 776 pairs of HIV-positive children and their caregivers were recruited, of whom 397 were in the intervention arm. Data were analyzed using instrumental variable random effects regression with panel data to examine the efficacy of the intervention on nutrition status through feeding practices. RESULTS Mean nutrition knowledge scores were higher post-training compared to pre-training among MLPs (37.1 vs. 23.5, p < 0.001). A mean increment weight gain of 300 g was also observed at follow-up compared to baseline among children of the intervention arm. Feeding frequency and dietary diversity improved following the intervention and a 6 months follow-up (p < 0.001). An increase in each unit of feeding frequency and dietary diversity were associated with a 0.15-unit and a 0.16-unit respectively decrease in the child underweight (p < 0.001). CONCLUSIONS Nutrition training improved nutrition knowledge among MLPs caring for HIV-positive children attending CTCs in Tanga, Tanzania. Caregivers' feeding practices also improved, which in turn led to a modest weight gain among HIV-positive children. To sustain weight gain, efforts should be made to also improve households' food security and caregivers' education in addition to inservice nutrition trainings. The protocol was registered on 15/02/2013, before the recruitment at ISRCTN trial registry with the trial registration number: ISRCTN65346364.
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Feeding strategies in pediatric cancer patients with gastrointestinal mucositis: a multicenter prospective observational study and international survey.
Kuiken, NSS, Rings, EHHM, van den Heuvel-Eibrink, MM, van de Wetering, MD, Tissing, WJE
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2017;(10):3075-3083
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Abstract
INTRODUCTION Currently, there is no adequate prevention or treatment for both oral and gastrointestinal mucositis induced by chemotherapy and/or radiotherapy. Supportive care of symptoms plays a primary role during mucositis in the pediatric clinical setting. We aimed to get insight in the currently used feeding strategies in clinical practice in pediatric cancer patients with chemotherapy-induced mucositis. METHODS A prospective observational study was performed to identify feeding strategies after chemotherapy courses causing mucositis in almost all patients at the University Medical Center Groningen (UMCG), the Academic Medical Center Amsterdam (AMC), and the Princess Maxima Center Utrecht (PMC). Consecutive patients, aged 0-18 years, either diagnosed with B cell non-Hodgkin lymphoma (B-NHL) or scheduled for autologous stem cell transplantation (SCT) between April 2015 and September 2016 were included in this study. In addition to the observational study in the Netherlands, an international online questionnaire was conducted for pediatric oncology centers. RESULTS A total of 13 patients were included, after 21 chemotherapy courses. No nutritional support was administered after 23.8% courses, tube feeding after 19.0% of the courses, TPN in 19.0% of courses, and 38.1% received a combination of tube feeding and TPN. The international survey revealed that 63.2% of the centers administered tube feeding as first choice, 31.6% administered only TPN as first choice, and one center administered a combination as first choice. CONCLUSIONS There is a variability in feeding strategies in the clinical practice both in the Netherlands as well as worldwide. This study is a basis for future studies in this important clinical field to develop clinical trials comparing tube feeding and TPN both in adult and pediatric patients.
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An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO.
Märten, A, Wente, MN, Ose, J, Büchler, MW, Rötzer, I, Decker-Baumann, C, Karapanagiotou-Schenkel, I, Harig, S, Schmidt, J, Jäger, D
BMC cancer. 2009;:412
Abstract
BACKGROUND Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival. Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for. METHODS/DESIGN PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first). DISCUSSION The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma. TRIAL REGISTRATION Current Controlled Trials ISRCTN60516908.