Conectar
by Alex Buga, David G. Harper, Teryn N. Sapper, Parker N. Hyde, Brandon Fell, Ryan Dickerson, Justen T. Stoner, Madison L. Kackley, Christopher D. Crabtree, Drew D. Decker, Bradley T. Robinson, Gerald Krystal, Katherine Binzel, Maryam B. Lustberg, Jeff S. Volek
PurposeKetogenic diets may positively influence cancer through pleiotropic mechanisms, but only a few small and short-term studies have addressed feasibility and efficacy in cancer patients. The primary goals of this study were to evaluate the feasibility and the sustained metabolic effects of a personalized well-formulated ketogenic diet (WFKD) designed to achieve consistent blood beta-hydroxybutyrate (βHB) >0.5 mM in women diagnosed with stage IV metastatic breast cancer (MBC) undergoing chemotherapy.
MethodsWomen (n = 20) were enrolled in a six month, two-phase, single-arm WFKD intervention (NCT03535701). Phase I was a highly-supervised, ad libitum, personalized WFKD, where women were provided with ketogenic-appropriate food daily for three months. Phase II transitioned women to a self-administered WFKD with ongoing coaching for an additional three months. Fasting capillary βHB and glucose were collected daily; weight, body composition, plasma insulin, and insulin resistance were collected at baseline, three and six months.
ResultsCapillary βHB indicated women achieved nutritional ketosis (Phase I mean: 0.8 mM (n = 15); Phase II mean: 0.7 mM (n = 9)). Body weight decreased 10% after three months, primarily from body fat. Fasting plasma glucose, plasma insulin, and insulin resistance also decreased significantly after three months (p Conclusions
Women diagnosed with MBC undergoing chemotherapy can safely achieve and maintain nutritional ketosis, while improving body composition and insulin resistance, out to six months.
by Sian Reece, Josie Dickerson, Brian Kelly, Rosemary R. C. McEachan, Kate E. Pickett
There is growing recognition that the public health measures employed to control the spread of the COVID-19 pandemic had unintended consequences on socioeconomic security and health inequalities, having the greatest impact on the most vulnerable groups. This longitudinal study aims to explore the medium to long-term impacts of the COVID-19 pandemic and subsequent public health measures on financial security for families living in the deprived and ethnically diverse city of Bradford. We collected data at four time points before and during the pandemic from mothers who participated in one of two prospective birth cohort studies in Bradford. The findings demonstrate that the risk of experiencing financial insecurity rose sharply during the pandemic and has not returned to pre-COVID-19 baseline levels. Several individual characteristics were found to be possible predictors of financial insecurity, including homeowner status, free school meal eligibility and not working. Protective factors against financial insecurity include: living in more affluent areas; greater levels of educational attainment; and families with two or more adults in the household. Notably, families of Pakistani Heritage were found to have the greatest risk of experiencing financial insecurity throughout the pandemic. Furthermore, this study demonstrated that there were strong associations between financial insecurity and maternal health and wellbeing outcomes, with mothers experiencing financial insecurity being more likely to report unsatisfactory general health and clinically important symptoms of depression and anxiety. The findings of this study highlight that the impact of financial insecurity experienced by mothers and their families throughout the pandemic was severe, wide ranging and affected the most vulnerable. In the wake of the pandemic, the emerging cost of living and energy crisis emphasises the urgent need for policy makers to act to support vulnerable families to prevent further widening of existing health and social inequalities.Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.
An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.
Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.
Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).
Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives’ and women’s perspectives.
Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.
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