Lessons Learned From the Creating Active Communities and Healthy Environments Toolkit Pilot: A Qualitative Study.
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ABSTRACT:
SUBMITTER: Shams-White MM
PROVIDER: S-EPMC6628517 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
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Lessons Learned From the Creating Active Communities and Healthy Environments Toolkit Pilot: A Qualitative Study.
Shams-White Marissa M MM Cuccia Alison A Ona Fernando F Bullock Steven S Chui Kenneth K McKeown Nicola N Must Aviva A
Environmental health insights 20190712
The US Army Public Health Center developed the Creating Active Communities and Healthy Environments (CACHE) Toolkit to help military installations evaluate the quality of their built environments relative to healthy eating, physical activity, and tobacco-free living. This study sought to improve its implementation process and assess subsequent Action Plan Guides' utility at 5 military installations. Baseline data included a knowledge, attitudes, and beliefs survey (N = 34); post-Toolkit implemen ...[more]
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Project description:BackgroundThe Healthy Communities Study (HCS) was a national study of community programs and policies that aimed to address childhood obesity; it necessitated recruitment of a large sample of children from communities throughout the United States.ObjectiveThe HCS aimed to complete visits with an average of 45 children and 12 key informants from at least 120 communities, diverse with respect to region of the country, urbanicity, socioeconomic status, race, ethnicity and intensity of community programs and policies that aim to address childhood obesity.MethodsPurchased address lists were utilized to select households for recruitment during Wave 1 of the study, and recruitment of families through schools was employed for Wave 2.ResultsThe HCS successfully obtained approval from 149 school districts and 478 schools in 130 communities, recruited 5138 families, and interviewed 1421 key informants to allow for characterization of overall intensity of obesity prevention/treatment efforts in each community.ConclusionsLessons learned are presented. Future studies should plan for inclusion of the following in development of recruitment strategies: literature review, formative research, pilot testing, and ongoing monitoring and adjustment.
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Project description:ObjectivesEffective government policies are essential to increase the healthiness of food environments. The International Network for Food and Obesity/non-communicable diseases (NCDs) Research, Monitoring and Action Support (INFORMAS) has developed a monitoring tool (the Healthy Food Environment Policy Index (Food-EPI)) and process to rate government policies to create healthy food environments against international best practice. The aims of this study were to pilot test the Food-EPI, and revise the tool and process for international implementation.SettingNew Zealand.ParticipantsThirty-nine informed, independent public health experts and non-governmental organisation (NGO) representatives.Primary and secondary outcome measuresEvidence on the extent of government implementation of different policies on food environments and infrastructure support was collected in New Zealand and validated with government officials. Two whole-day workshops were convened of public health experts and NGO representatives who rated performance of their government for seven policy and seven infrastructure support domains against international best practice. In addition, the raters evaluated the level of difficulty of rating, and appropriateness and completeness of the evidence presented for each indicator.ResultsInter-rater reliability was 0.85 (95% CI 0.81 to 0.88; Gwet's AC2) using quadratic weights, and increased to 0.89 (95% CI 0.85 to 0.92) after deletion of the problematic indicators. Based on raters' assessments and comments, major changes to the Food-EPI tool include strengthening the leadership domain, removing the workforce development domain, a stronger focus on equity, and adding community-based programmes and government funding for research on obesity and diet-related NCD prevention, as good practice indicators.ConclusionsThe resulting tool and process will be promoted and offered to countries of varying size and income globally. International benchmarking of the extent of government policy implementation on food environments has the potential to catalyse greater government action to reduce obesity and NCDs, and increase civil society's capacity to advocate for healthy food environments.
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Project description:Introduction: Peri-operative window trials, using molecular biomarkers as surrogate endpoints for treatment response, offer investigators a uniqueopportunity to obtain intact tumor samples at 2 different time-points and thus evaluate potential biomarkers over a short period of time. Here we report results of a pilot trial designed to determine if treatment-mediated changes in gene expression can be detected after a 10-day exposure to anastrozole in estrogen receptor (ER)-positive breast cancer compared to untreated controls. Methods: Paired tumor samples (biopsy and surgical) were obtained from 26 postmenopausal women with ER-positive breast cancer. Patients were assigned anastrozole (1mg/dy) for 10 days immediately prior to surgery (13 cases) or no treatment (13 controls). 502 cancer-related genes were examined by the DASL FFPE-based cDNA array (moderated t-test, p ≤ .005). Surrogate biomarkers reflecting changes in gene expression were examined by immunohistochemistry (IHC) (Wilcoxon rank-based test, p < .05). Results: Sufficient RNA was available from 19 paired samples (8 controls, 11 cases). There was no difference in age, tumor size, grade, or baseline biomarker expression between groups. Within each group, 18 genes, reflecting roles in proliferation, angiogenesis, and apoptosis showed differential expression over time from biopsy to surgery (p < 0.005). Dysregulation of estrogen-related genes was present only in the treated group. Comparison between groups identified 5 genes that were significantly dysregulated between controls and treated cases (BAG1/ING1/ERBB4/IFNGR1/TFDP1). Reduction in Ki-67 index was observed in 7 (54%) treated cases in 1 (7.7%) control patient. Conclusions: Short-term (10-day) exposure to anastrozole resulted in significant dysregulation of 18 out of 502 cancer-related genes, and Ki-67 was reduced in 54% of cases. However, the local effects of wound healing may represent a confounding factor in the interpretation of peri-operative window trials as exposed by the changes in gene expression and the increased Ki-67 index in the control group. Prospective, paired tumor samples (biopsy and surgical) were obtained from 26 postmenopausal women with ER-positive breast cancer. Patients were assigned anastrozole (1mg/dy) for 10 days immediately prior to surgery (13 cases) or no treatment (13 controls). 502 cancer-related genes were examined by the DASL FFPE-based cDNA array. Sufficient RNA for gene expression analysis was obtained from 19/26 (73%) FFPE paired (biopsy and surgery) samples (8 controls, 11 anastrozole-treated patients
2011-07-01 | E-GEOD-26544 | biostudies-arrayexpress
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2011-07-01 | GSE26544 | GEO
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Project description:BACKGROUND:Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS:We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS:Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15?months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS:Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.
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Project description:Background and purposePediatric populations represent a vulnerable research group. Careful thought must be given to many factors when designing and implementing pediatric intervention research studies. This article discusses methodological and implementation lessons learned from two pediatric intervention pilot studies and highlights facilitators and barriers encountered.Type of methodBoth studies used a pre/post with 6-week follow-up method and were adapted versions of an evidence-based program, Creating Opportunities for Personal Empowerment (COPE).Essential featuresCOPE is a 7-session, cognitive behavioral skills building intervention. COPE for Asthma was implemented in schools with small groups for elementary-aged children with asthma and symptoms of anxiety. Mindstrong to Combat Bullying was implemented individually in the outpatient mental health setting for adolescents who had experienced bullying with concurrent symptoms of depression/anxiety.Methodological applicationBoth intervention studies were successful in achieving their research aims, but more importantly the authors learned important lessons in how to successfully work with pediatric populations in research studies. Legal considerations, such as mandated reporting, suicide risk assessment and the inclusion of parents are reviewed. Other components, such as working with children vs. adolescents, integrating research into school-based settings vs. clinic-based settings, and completing intervention research in a group setting vs. individual setting are discussed.ConclusionsThe two pilot studies highlight important factors to consider when designing and implementing pediatric intervention studies. While challenges arise in working with this vulnerable population, research is ultimately needed to provide the best evidence-based care for our future generations.Clinical trial registrationThe COPE for Asthma study is registered at www.ClinicaltrialsgovNCT03481673.
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