Scaling up evidence-based digital early life nutrition interventions in a county setting: an implementation trial - protocol for Phase 2 of the Nutrition Now project.

Background: Few effective health interventions transition from smaller efficacy or effectiveness studies to real-world implementation at scale, representing a gap between evidence and practice. Recognising this, we have developed Nutrition Now - a tailored digital resource building on four efficacious dietary interventions, aiming to improve nutrition in the important first 1,000 days of life. Nutrition Now targets and guides expectant parents and parents of 0-2 year olds, serves as a reliable source of evidence-based information for midwives and public health nurses at maternal and child healthcare (MCH) centres, and offers pedagogical tools for early childhood education and care (ECEC) staff. The aim of this study is to implement Nutrition Now at scale and evaluate the impact of different sets of multifaceted implementation strategies on implementation outcomes. Methods: A quasi-experimental design with three study arms will be used, providing either low, medium or high implementation support, when rolled out in 50 municipalities in 2 counties in Norway. Nutrition Now will be implemented in MCH and ECEC settings and made available to expectant parents and parents of 0-2 year olds through social media and MCH. The implementation support builds on strategies described in the Expert Recommendations for Implementing Change (ERIC) implementation framework and is informed by dialogues with stakeholders. Impact of the different degree of implementation support will be assessed by examining reach, adoption, fidelity, and sustainability using usage data generated from the Nutrition Now resource, publicly available municipal data and qualitative interviews with MCH and ECEC staff. Discussion: Nutrition Now Phase 2 will break new ground by scaling up successively delivered and complementary dietary interventions in the first 1,000 days of life in a real-life context. The project also seeks to identify what level of implementation support is most effective when implementing digital, scalable, evidence-based early-life nutrition interventions in community settings. The project will inform implementation research and provide knowledge about effective implementation strategies to be used in a national scale-up of Nutrition Now. Trial registration: The study is registered prospectively (submitted 14/06/2022, registration date: 19/06/2022) in the International Standard Randomised Controlled Trial Number registry (ISRCTN): reg. Number: ISRCTN10694967, https://doi.org/10.1186/ISRCTN10694967.

Evaluating the effectiveness and implementation of evidence-based early-life nutrition interventions in a community setting a hybrid type 1 non-randomized trial - the Nutrition Now project protocol.

Disappointingly few efficacious health interventions are successfully scaled up and implemented in real world settings. This represents an evidence-to-practice gap, with loss of opportunity to improve practice. Aiming to improve nutrition in the first 1000 days of life, we have combined four efficacious dietary interventions into a single adapted digital resource (Nutrition Now) for implementation in a Norwegian community setting. Nutrition Now targets pregnant women and parents of 0-2-year-olds with messages focusing on healthy dietary behaviours. Early childhood education and care (ECEC) staff are provided with pedagogical tools addressing healthy food exposure and child food acceptance. Objectives: a) evaluate the effectiveness of provision of the Nutrition Now resource on child diet and diet-related outcomes, with special attention to the influence of socio-economic position, b) gather information on the effectiveness of the implementation process to inform forthcoming scale-up and c) perform trial- and model-based economic evaluations. This is a hybrid type 1 implementation study, focusing on evaluation of effectiveness. A quasi-experimental design with pre- and post-tests, where one municipality gets access to the resource (n~800), while a matched non-equivalent control municipality (n~800) does not, will be used. Effectiveness will be assessed by examining e.g., diet outcomes, developmental outcomes, and feeding practices. The resource will be implemented in ECEC settings and made available to pregnant women and parents through the Norwegian system of maternal and child health (MCH) care. The implementation process includes iterative adjustments and implementation strategies from the implementation framework Expert Recommendations for Implementing Change (ERIC) informed by dialogues with stakeholders. Implementation outcomes (e.g., acceptability and adoption) will be assessed through questionnaires and interviews with parents, ECEC and MCH staff, with particular attention to ethnic diverse groups. Both within-trial and modelling-based economic evaluation will be performed. Nutrition Now will bridge the existing evidence-to-practice gap through rigorous scientific effectiveness evaluation of municipal scale up and inform subsequent county scale up. The study is the first to implement efficacious nutrition interventions in early life with potential for health improvement using technology to maximise the reach and impact of both parental and MCH dietary guidance and ECEC practice. Clinical Trial Registration: https://www.isrctn.com/, identified ISRCTN10694967.

Lifestyle changes in cancer patients undergoing curative or palliative chemotherapy: is it feasible?

INTRODUCTION: This study aimed to explore the feasibility of an individualized comprehensive lifestyle intervention in cancer patients undergoing curative or palliative chemotherapy. MATERIAL AND METHODS: At one cancer center, serving a population of 180,000, 100 consecutive of 161 eligible newly diagnosed cancer patients starting curative or palliative chemotherapy entered a 12-month comprehensive, individualized lifestyle intervention. Participants received a grouped startup course and monthly counseling, based on self-reported and electronically evaluated lifestyle behaviors. Patients with completed baseline and end of study measurements are included in the final analyses. Patients who did not complete end of study measurements are defined as dropouts. RESULTS: More completers (n = 61) vs. dropouts (n = 39) were married or living together (87 vs. 69%, p = .031), and significantly higher baseline physical activity levels (960 vs. 489 min.wk-1, p = .010), more healthy dietary choices (14 vs 11 points, p = .038) and fewer smokers (8 vs. 23%, p = .036) were observed among completers vs. dropouts. Logistic regression revealed younger (odds ratios (OR): 0.95, 95% confidence interval (CI): 0.91, 0.99) and more patients diagnosed with breast cancer vs. more severe cancer types (OR: 0.16, 95% CI: 0.04, 0.56) among completers vs. dropouts. Improvements were observed in completers healthy (37%, p < 0.001) and unhealthy dietary habits (23%, p = .002), and distress (94%, p < .001). No significant reductions were observed in physical activity levels. Patients treated with palliative intent did not reduce their physical activity levels while healthy dietary habits (38%, p = 0.021) and distress (104%, p = 0.012) was improved. DISCUSSION: Favorable and possibly clinical relevant lifestyle changes were observed in cancer patients undergoing curative or palliative chemotherapy after a 12-month comprehensive and individualized lifestyle intervention. Palliative patients were able to participate and to improve their lifestyle behaviors.

Individualized Comprehensive Lifestyle Intervention in Patients Undergoing Chemotherapy with Curative or Palliative Intent: Who Participates?

OBJECTIVE: Knowledge about determinants of participation in lifestyle interventions in cancer patients undergoing chemotherapy, particularly with palliative intent, remains poor. The objective of the present study was to identify determinants of participating in a 12 month individualized, comprehensive lifestyle intervention, focusing on diet, physical activity, mental stress and smoking cessation, in cancer patients receiving chemotherapy with curative or palliative intent. The secondary objective was to identify participation determinants 4 months into the study. METHODS: Newly diagnosed cancer patients starting chemotherapy at the cancer center in Kristiansand/Norway (during a 16 month inclusion period) were screened. Demographic and medical data (age, sex, body mass index, education level, marital status, smoking status, Eastern Cooperative Oncology Group performance status (ECOG), diagnosis, tumor stage and treatment intention) was analyzed for screened patients. RESULTS: 100 of 161 invited patients participated. There were more females (69 vs. 48%; P = 0.004), breast cancer patients (46 vs. 25%; P = 0.007), non-smokers (87 vs. 74%; P = 0.041), younger (mean age 60 vs. 67 yrs; P < 0.001) and fitter (82 vs. 64% with EGOC 0; P = 0.036) participants vs. non-participants included. In multivariate logistic regression analyses, age (Odds Ratio 0.94, 95% Confidence Interval 0.91, 0.97) and smoking (0.42, 0.18, 0.99) were negatively associated with participation. After 4 months, 63 participants were still participating. Cancer type, smoking and age increased the probability of dropping out. Multivariate logistic regression revealed that age was the only significant determinant of 4 month participation (0.95, 0.91, 0.99). Patients aged >70 years were less likely to participate at baseline and 4 months. CONCLUSION: Individualized lifestyle interventions in cancer patients undergoing chemotherapy appear to facilitate a high participation rate that declines with increasing age; both during the enrollment process and completing the intervention. Neither oncologic nor socioeconomic variables deterred participation.

IL-7 is expressed and secreted by human skeletal muscle cells.

In addition to generating movement, skeletal muscle may have a function as a secretory organ. The aim of the present study was to identify novel proteins with signaling capabilities secreted from skeletal muscle cells. IL-7 was detected in media conditioned by primary cultures of human myotubes differentiated from satellite cells, and concentrations increased with incubation time. By immunoblotting and real-time RT-PCR IL-7 expression was confirmed at both protein and mRNA levels. Furthermore, with immunofluorescence and specific antisera, multinucleated myotubes were found to coexpress IL-7 and myosin heavy chain. During differentiation of human myotubes from satellite cells, IL-7 expression increased at mRNA and protein levels. In contrast, mRNA expression of the IL-7 receptor was 80% lower in myotubes compared with satellite cells. Incubations with recombinant IL-7 under differentiation conditions caused approximately 35% reduction in mRNA for the terminal myogenic markers myosin heavy chain 2 (MYH2) and myogenin (MYOG), suggesting that IL-7 may act on satellite cells to inhibit development of the muscle fiber phenotype. Alternative routes of cell development were investigated, and IL-7 increased migration of satellite cells by 40% after 48 h in a Transwell system, whereas cell proliferation remained unchanged. In vivo, real-time RT-PCR analysis of musculus vastus lateralis (n = 10) and musculus trapezius (n = 7) biopsies taken from male individuals undergoing a strength training program demonstrated that after 11 wk mean IL-7 mRNA increased by threefold (P = 0.01) and fourfold (P = 0.04), respectively. In conclusion, we have demonstrated that IL-7 is a novel myokine regulated both in vitro and in vivo, and it may play a role in the regulation of muscle cell development.