Modifications to Communities for Healthy Living trial design resulting from COVID-19.
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ABSTRACT:
SUBMITTER: Davison KK
PROVIDER: S-EPMC7605818 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
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Modifications to Communities for Healthy Living trial design resulting from COVID-19.
Davison Kirsten K KK Haneuse Sebastien S
Contemporary clinical trials 20201102
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Project description: Not available
| S-EPMC7954776 | biostudies-literature
Project description:ObjectiveTo describe variations in COVID-19 confirmed cases and deaths among assisted living (AL) residents and examine their associations with key AL characteristics.DesignObservational study employing data on confirmed COVID-19 cases and deaths in ALs from seven states, through May 29, 2020.SettingInformation on COVID-19 cases/deaths in ALs was obtained from state government websites. A national inventory of ALs was used to identify communities with and without COVID-19 cases/deaths. Medicare Beneficiary Summary File identifying AL residents was employed to develop AL characteristics. County-level COVID-19 laboratory-confirmed cases/deaths were obtained from publicly available data.ParticipantsWe found 4,865 ALs (2,647 COVID-19 cases and 777 deaths) in the seven states. After excluding missing data, the sample consisted of 3,994 ALs (82.1%) with 2,542 cases (96.0%) and 675 deaths (86.9%).Main outcomes and measuresOutcomes were AL-level counts of cases and deaths. Covariates were AL characteristics and county-level confirmed COVID-19 cases/deaths. Multivariable two-part models determined the associations of independent variables with the likelihood of at least one case and death in the AL, and with the count of cases (deaths).ResultsState case fatality ranged from 3.32% in North Carolina to 9.26% in Connecticut, but for ALs in these states it was 12.89% and 31.59%, respectively. Among ALs with at least one case, midsize communities had fewer cases (incidence rate ratio (IRR) = 0.829; P = .004) than small ALs. ALs with higher proportions of racial/ethnic minorities had more COVID-19 cases (IRR = 1.08; P < .001), as did communities with higher proportions of residents with dementia, chronic obstructive pulmonary disease, and obesity.Conclusions and relevanceALs with a higher proportion of minorities had more COVID-19 cases. Many of the previously identified individual risk factors are also present in this vulnerable population. The impact of COVID-19 on ALs is as critical as that on nursing homes, and is worth equal attention from policy makers.
| S-EPMC7537218 | biostudies-literature
Project description: Not available
| S-EPMC7201230 | biostudies-literature
Project description:Mesenchymal stromal cells are a potential therapeutic for Acute Respiratory Distress Syndrome due to COVID-19, with pleiotropic immunomodulatory and reparative properties.This study investigated the safety and efficacy of ORBCEL-C (CD362 enriched umbilical cord-derived Mesenchymal Stromal Cells) in this patient population.
2023-06-20 | GSE231660 | GEO
Project description:Pediatric obesity is a major public health concern in low- and middle-income countries, such as Brazil. There is an urgent need for preventive programs for adolescents and, the assessment of their sustained impact. This paper reports the longer-term (6-month post intervention) effects of the "H3G-Brazil" obesity prevention program on weight status and weight-related behaviors. A cluster randomized controlled trial starting with 10 public schools in the city of São Paulo, Brazil involved 253 adolescent girls [mean (se) age = 15.6 (0.87) years]. Body mass index (BMI), waist circumference (WC), dietary intake, physical activity (PA) and sedentary behaviors (SB) were assessed at baseline, immediate post-intervention and 6-month post-intervention (follow-up). ANCOVA was performed using intention to treat principles. There was no effect on BMI, the primary outcome. Although, meaningful increases occurred in waist circumference for both groups, the intervention group presented a lower increase (F = 3.31, p = 0.04). This effect size, however, was lower than the criterion for small (d = 0.102). Unfortunately, significant results favored the control group for time spent on TV/weekdays (F = 5.13, p = 0.01), TV/weekends (F = 5.46, p = 0.01) and sedentary behaviors/weekdays (F = 5.32, p = 0.04). No other significant results were found. This obesity prevention intervention among Brazilian adolescent girls did not have the desire effect on BMI. The significantly lower increase in waist circumference in the intervention groups is inconsistent with the adverse changes detected in sedentary time.
| S-EPMC5984243 | biostudies-literature
Project description:The Healthy Communities Study is designed to assess relationships between characteristics of community programs and policies targeting childhood obesity and children's BMI, diet, and physical activity. The study involved a complex data collection protocol implemented over a 2-year period (2013-2015) across a diverse sample of 130 communities, defined as public high school catchment areas. The protocol involved baseline assessment within each community that included in-person or telephone interviews regarding community programs and policies and in-home collection of BMI, nutritional, and physical activity outcomes from a sample of up to 81 children enrolled in kindergarten through eighth grade in public schools. The protocol also involved medical record reviews to establish a longitudinal trajectory of BMI for an estimated 70% of participating children. Staged sampling was used to collect less detailed measures of physical activity and nutrition across the entire sample of children, with a subset assessed using more costly, burdensome, and detailed measures. Data from the Healthy Community Study will be analyzed using both cross-sectional and longitudinal models that account for the complex design and correct for measurement error and bias using a likelihood-based Markov-chain Monte Carlo methodology. This methods paper provides insights into the complex design features of the Healthy Communities Study and may serve as an example for future large-scale studies that assess the relationship between community-based programs and policies and health outcomes of community residents.
| S-EPMC4575768 | biostudies-literature
Project description:BACKGROUND:Women living in rural areas face unique challenges in achieving a heart-healthy lifestyle that are related to multiple levels of the social-ecological framework. The purpose of this study was to evaluate changes in diet and physical activity, which are secondary outcomes of a community-based, multilevel cardiovascular disease risk reduction intervention designed for women in rural communities. METHODS:Strong Hearts, Healthy Communities was a six-month, community-randomized trial conducted in 16 rural towns in Montana and New York, USA. Sedentary women aged 40 and older with overweight and obesity were recruited. Intervention participants (eight towns) attended twice weekly exercise and nutrition classes for 24 weeks (48 total). Individual-level components included aerobic exercise, progressive strength training, and healthy eating practices; a civic engagement component was designed to address social and built environment factors to support healthy lifestyles. The control group (eight towns) attended didactic healthy lifestyle classes monthly (six total). Dietary and physical activity data were collected at baseline and post-intervention. Dietary data were collected using automated self-administered 24-h dietary recalls, and physical activity data were collected by accelerometry and self-report. Data were analyzed using multilevel linear regression models with town as a random effect. RESULTS:At baseline, both groups fell short of meeting many recommendations for cardiovascular health. Compared to the control group, the intervention group realized significant improvements in intake of fruit and vegetables combined (difference: 0.6 cup equivalents per day, 95% CI 0.1 to 1.1, p = .026) and in vegetables alone (difference: 0.3 cup equivalents per day, 95% CI 0.1 to 0.6, p = .016). For physical activity, there were no statistically significant between-group differences based on accelerometry. By self-report, the intervention group experienced a greater increase in walking MET minutes per week (difference: 113.5 MET-minutes per week, 95% CI 12.8 to 214.2, p = .027). CONCLUSIONS:Between-group differences in dietary and physical activity behaviors measured in this study were minimal. Future studies should consider how to bolster behavioral outcomes in rural settings and may also continue to explore the value of components designed to enact social and environmental change. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT02499731. Registered 16 July 2015.
| S-EPMC6815048 | biostudies-literature
Project description:Pregnancy is a life stage where excess weight gain may occur and the postpartum period is often characterised by weight retention. The aim of the current study was to evaluate the feasibility of undertaking a randomised controlled trial of a weight loss intervention (WeighWell) in postpartum women living in areas of social disadvantage.The study aimed to recruit 60 women who were not pregnant, 6-18 months postpartum with a body mass index >25 kg/m(2) living in areas of deprivation within Tayside, UK. Recruitment strategies focused on visits to community groups; writing directly to postpartum women living in areas of deprivation and primary care teams who covered the most deprived 15% of the population and advertising in community settings. The 12-week intervention used motivational interviewing techniques to promote an energy deficit diet and increased physical activity, delivered by three face-to-face consultations plus three structured telephone calls.Of 142 women screened, 63 were eligible and 52 (83%) were recruited and randomised to an intervention (n=29) or comparison group (n=23). Over the 12-week intervention, body weight changed significantly by -1.6 ± 2.0 kg in the intervention group compared with +0.2 ± 2.2 kg in the comparison group, indicating the potential efficacy of the intervention. Loss to follow-up was 24% in the intervention group and 39% for the comparison group.The findings support the development of a definitive trial that embraces personalised recruitment strategies and the development of approaches to improve retention over a clinically relevant intervention period.
| S-EPMC3154650 | biostudies-literature
Project description:Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website ( COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
| S-EPMC7141164 | biostudies-literature
Project description:This article reviews the correlation between ACE2 and COVID-19 and the resulting acute respiratory distress syndrome (ARDS). ACE2 is a crucial component of the renin-angiotensin system (RAS). The classical ACE-angiotensin Ⅱ (Ang II)-angiotensin type 1 receptor (AT1R) axis and the ACE2-Ang(1-7)-Mas counter-regulatory axis play an essential role in RAS system. ACE2 antagonises the activation of the classical RAS ACE-Ang II-AT1R axis and protects against lung injury. Similar to severe acute respiratory syndrome-related coronavirus, 2019 novel coronavirus (2019-nCoV) also uses ACE2 for cell entry. ARDS is a clinical high-mortality disease which is probably due to the excessive activation of RAS caused by 2019-nCoV infection, and ACE2 has a protective effect on ARDS caused by COVID-19. Because of these protective effects of ACE2 on ARDS, the development of drugs enhancing ACE2 activity may become one of the most promising approaches for the treatment of COVID-19 in the near future. In the meantime, however, the use of RAS blockers such as ACE inhibitors and angiotensin II receptor blockers that inhibit the damaging (ACE-Ang II) arm of the RAS cascade in the lung may also be promising. Trial registration number: NCT04287686.
| S-EPMC10016912 | biostudies-literature