Associations between BMI and home, school and route environmental exposures estimated using GPS and GIS: do we see evidence of selective daily mobility bias in children?

BACKGROUND: This study examined whether objective measures of food, physical activity and built environment exposures, in home and non-home settings, contribute to children's body weight. Further, comparing GPS and GIS measures of environmental exposures along routes to and from school, we tested for evidence of selective daily mobility bias when using GPS data. METHODS: This study is a cross-sectional analysis, using objective assessments of body weight in relation to multiple environmental exposures. Data presented are from a sample of 94 school-aged children, aged 5-11 years. Children's heights and weights were measured by trained researchers, and used to calculate BMI z-scores. Participants wore a GPS device for one full week. Environmental exposures were estimated within home and school neighbourhoods, and along GIS (modelled) and GPS (actual) routes from home to school. We directly compared associations between BMI and GIS-modelled versus GPS-derived environmental exposures. The study was conducted in Mebane and Mount Airy, North Carolina, USA, in 2011. RESULTS: In adjusted regression models, greater school walkability was associated with significantly lower mean BMI. Greater home walkability was associated with increased BMI, as was greater school access to green space. Adjusted associations between BMI and route exposure characteristics were null. The use of GPS-actual route exposures did not appear to confound associations between environmental exposures and BMI in this sample. CONCLUSIONS: This study found few associations between environmental exposures in home, school and commuting domains and body weight in children. However, walkability of the school neighbourhood may be important. Of the other significant associations observed, some were in unexpected directions. Importantly, we found no evidence of selective daily mobility bias in this sample, although our study design is in need of replication in a free-living adult sample.

Application of the Intervention Mapping protocol to develop Keys, a family child care home intervention to prevent early childhood obesity.

BACKGROUND: Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHs METHODS: Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planning RESULTS: Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trial CONCLUSIONS: The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs.

Watch me grow: a garden-based pilot intervention to increase vegetable and fruit intake in preschoolers.

BACKGROUND: Americans, including children, consume fewer fruit and vegetable servings than is recommended. Given that young children spend large amounts of time in child care centers, this may be an ideal venue for increasing consumption of and enthusiasm for fruits and vegetables. This pilot study aimed to assess the feasibility of a gardening intervention to promote vegetable and fruit intake among preschoolers. METHODS: We enrolled two intervention centers and two control centers. The intervention included a fruit and vegetable garden, monthly curriculum, gardening support, and technical assistance. We measured mean (SD) servings of fruits and vegetables served to and consumed by three children per center before and after the intervention. RESULTS: Post intervention, intervention and control centers served fewer vegetables (mean (standard deviation) difference of -0.18 (0.63) in intervention, -0.37 (0.36) in control), but intervention children consumed more than control children (+0.25 (1.11) vs. -0.18 (0.52). The number of fruits served decreased in all centers (intervention -0.62 (0.58) vs. control -0.10 (0.52)) but consumption was higher in controls (intervention -0.32 (0.58) vs. control 0.15 (0.26)). CONCLUSIONS: The garden-based feasibility study shows promise, but additional testing is needed to assess its ability to increase vegetable and fruit intake in children.

Changes in physical activity among postpartum overweight and obese women: results from the KAN-DO Study.

Few studies have assessed physical activity at multiple time points in the postpartum period or used both self-reported and objective measures of assessment. The purpose of this study was to describe physical activity and sedentary behavior at two time points in a cohort of overweight or obese postpartum women using both self-reported and objective measures. In total, 132 women completed physical activity assessments at a median of 24 weeks postpartum and again approximately 10 months later. At both time points, women wore an Actical accelerometer for one week and completed the Kaiser Physical Activity Survey. Adjusted Poisson regression models were used to determine whether physical activity changed over time for the cohort. Overall counts per minute and moderate to vigorous physical activity increased from baseline to 10 months later, although the absolute levels were modest (median 6.9 to 8.8 minutes/day). A median of 64%-71% at baseline and 63%-67% at follow-up of their monitored times were sedentary. More intensive interventions are needed to help postpartum women integrate physical activity and reduce sedentary behavior. [Supplementary material is available for this article. Go to the publisher's online edition of Women & Health for the following resource: three figures that show the distribution of physical activity and sedentary behavior by study periods among control participants].

Tackling standardization in clinical research workforce hiring using competency-based job classifications.

In 2016, Duke reconfigured its clinical research job descriptions and workforce to be competency-based, modeled around the Joint Taskforce for Clinical Trial Competency framework. To ensure consistency in job classification amongst new hires in the clinical research workforce, Duke subsequently implemented a Title Picker tool. The tool compares the research unit's description of job responsibility needs against those standardized job descriptions used to map incumbents in 2016. Duke worked with human resources and evaluated the impact on their process as well as on the broader community of staff who hire clinical research professionals. Implementation of the tool has enabled Duke to create consistent job classifications for its workforce and better understand who composes the clinical research professional workforce. This tool has provided valuable workforce metrics, such as attrition, hiring, etc., and strengthened our collaboration with Human Resources.

Needles in a Haystack: Finding Qualitative and Quantitative Collaborators in Academic Medical Centers.

Translational research is a data-driven process that involves transforming scientific laboratory- and clinic-based discoveries into products and activities with real-world impact to improve individual and population health. Successful execution of translational research requires collaboration between clinical and translational science researchers, who have expertise in a wide variety of domains across the field of medicine, and qualitative and quantitative scientists, who have specialized methodologic expertise across diverse methodologic domains. While many institutions are working to build networks of these specialists, a formalized process is needed to help researchers navigate the network to find the best match and to track the navigation process to evaluate an institution's unmet collaborative needs. In 2018, a novel analytic resource navigation process was developed at Duke University to connect potential collaborators, leverage resources, and foster a community of researchers and scientists. This analytic resource navigation process can be readily adopted by other academic medical centers. The process relies on navigators with broad qualitative and quantitative methodologic knowledge, strong communication and leadership skills, and extensive collaborative experience. The essential elements of the analytic resource navigation process are as follows: (1) strong institutional knowledge of methodologic expertise and access to analytic resources, (2) deep understanding of research needs and methodologic expertise, (3) education of researchers on the role of qualitative and quantitative scientists in the research project, and (4) ongoing evaluation of the analytic resource navigation process to inform improvements. Navigators help researchers determine the type of expertise needed, search the institution to find potential collaborators with that expertise, and document the process to evaluate unmet needs. Although the navigation process can create a basis for an effective solution, some challenges remain, such as having resources to train navigators, comprehensively identifying all potential collaborators, and keeping updated information about resources as methodologists join and leave the institution.

Parent-focused change to prevent obesity in preschoolers: results from the KAN-DO study.

OBJECTIVE: The study presents the immediate post-intervention results of Kids and Adults Now - Defeat Obesity!, a randomized controlled trial to enhance healthy lifestyle behaviors in mother-preschooler (2-5 years old) dyads in North Carolina (2007-2011). The outcomes include change from baseline in the child's diet, physical activity and weight, and in the mother's parenting behaviors, diet, physical activity, and weight. METHOD: The intervention targeted parenting through maternal emotion regulation, home environment, feeding practices, and modeling of healthy behaviors. 400 mother-child dyads were randomized. RESULTS: Mothers in the intervention arm, compared to the control arm, reduced instrumental feeding (-0.24 vs. 0.01, p<0.001) and TV snacks (-.069 vs. -0.24, p=0.001). There were also improvements in emotional feeding (p=0.03), mother's sugary beverage (p=0.03) and fruit/vegetable (p=0.04) intake, and dinners eaten in front of TV (p=0.01); these differences were not significant after adjustment for multiple comparisons. CONCLUSION: KAN-DO, designed to maximize the capacity of mothers as agents of change, improved several channels of maternal influence. There were no group differences in the primary outcomes, but differences were observed in the parenting and maternal outcomes and there were trends toward improvement in the preschoolers' diets. Long-term follow-up will address whether these short-term trends ultimately improve weight status.

Can physicians accurately predict which patients will lose weight, improve nutrition and increase physical activity?

BACKGROUND: Physician counselling may help patients increase physical activity, improve nutrition and lose weight. However, physicians have low outcome expectations that patients will change. The aims are to describe the accuracy of physicians' outcome expectations about whether patients will follow weight loss, nutrition and physical activity recommendations. The relationships between physician outcome expectations and patient motivation and confidence also are assessed. METHODS: This was an observational study that audio recorded encounters between 40 primary care physicians and 461 of their overweight or obese patients. We surveyed physicians to assess outcome expectations that patients will lose weight, improve nutrition and increase physical activity after counselling. We assessed actual patient change in behaviours from baseline to 3 months after the encounter and changes in motivation and confidence from baseline to immediately post-encounter. RESULTS: Right after the visit, ~55% of the time physicians were optimistic that their individual patients would improve. Physicians were not very accurate about which patients actually would improve weight, nutrition and physical activity. More patients had higher confidence to lose weight when physicians thought that patients would be likely to follow their weight loss recommendations. CONCLUSIONS: Physicians are moderately optimistic that patients will follow their weight loss, nutrition and physical activity recommendations. Patients might perceive physicians' confidence in them and thus feel more confident themselves. Physicians, however, are not very accurate in predicting which patients will or will not change behaviours. Their optimism, although helpful for patient confidence, might make physicians less receptive to learning effective counselling techniques.

Sexual functioning in obese adults enrolling in a weight loss study.

The authors assessed sexual functioning among treatment-seeking obese men (n = 91) and women (n = 134) using the comprehensive validated Sexual Functioning Questionnaire. Scores were lower for women than for men, indicating reduced sexual functioning. Men's scores fell between those of a group of cancer survivors and a general population group, whereas women generally had lower scores than both of these groups. Increasing body mass index was associated with decreasing sexual functioning only for arousal and behavior. Sexual functioning was also reduced on most subscales for individuals who reported sexual inactivity in the past month.

Correlates of sedentary time and physical activity among preschool-aged children.

INTRODUCTION: Few studies have examined the correlates of objectively measured amounts of sedentary time and physical activity in young children. We evaluated the demographic, biological, behavioral, social, and environmental correlates of the amount of sedentary time and moderate-to-vigorous physical activity (MVPA) as measured by accelerometry in preschool-aged children. METHODS: We obtained baseline measurements of physical activity by using an Actical accelerometer among 337 preschool-aged children (aged 2-5) of overweight or obese mothers. For children, we defined sedentary time as less than 12 counts per 15 seconds and MVPA as 715 or more counts per 15 seconds. Body mass index of the mother and child (calculated from measured height and weight) and maternal physical activity as measured by accelerometer were included as potential correlates. Mothers self-reported all other potential correlates. We used multivariable linear regression analyses to examine correlates of the amount of sedentary time and MVPA. RESULTS: Children had an average of 6.1 hours per day of sedentary time and 14.9 minutes per day of MVPA. In multivariable analysis, boys (P <.001) had fewer minutes per day of sedentary time, whereas older children (P <.001), boys (P <.001), children in high-income households (>$60,000/y [P = .005]), and children who spent more time outdoors (P = .001) had more MVPA. CONCLUSION: Both modifiable and nonmodifiable factors were correlated with preschool children's amount of MVPA, which can be helpful when designing interventions for this age group. The lack of correlates for sedentary time indicates the need for further investigation into this behavior.

Is pregnancy a teachable moment for smoking cessation among US Latino expectant fathers? A pilot study.

OBJECTIVE: Pregnancy may be a time when US Latino expectant fathers consider quitting smoking. A 'teachable moment' is theorized to increase motivation to change a behavior through increased risk perceptions, emotional responses, and changes in self-image. DESIGN: We recruited 30 Spanish-speaking expectant fathers through their pregnant partners. We assessed expectant fathers' diet, exercise, and smoking and teachable moment constructs (risk perceptions, emotional responses, and self-image).We also tested correlations between teachable moment constructs and motivation to change behaviors. RESULTS: Latino expectant fathers had high-risk perceptions that their smoking harmed the pregnancy (M=4.4, SD=0.5 on five-point scale) and strong emotional responses about their smoking during pregnancy (M=3.9, SD=1.1). They also felt it was their role to make the pregnancy healthy (M=4.4, SD=0.8). They felt less strongly that their diet and exercise affected the pregnancy. The teachable moment constructs for smoking were strongly correlated with motivation to quit smoking; the same was not true for diet and exercise. CONCLUSIONS: Latino expectant fathers seem aware that their smoking could harm the pregnancy but seem less concerned about the effect of their diet and exercise on the pregnancy. Pregnancy may be a time to help Latino expectant fathers quit smoking.

Impact of implementing a competency-based job framework for clinical research professionals on employee turnover.

INTRODUCTION: A new competency-based job framework was implemented for clinical research professionals at a large, clinical research-intensive academic medical center. This study evaluates the rates of turnover before and after implementation of the new framework. Turnover in this workforce (as with most) is costly; it contributes to wasted dollars and lost productivity since these are highly specialized positions requiring extensive training, regardless of experience in the field. METHODS: Trends in employee turnover for 3 years prior to and after the implementation of competency-based job framework for clinical research positions were studied using human resources data. Employee demographics, turnover rates, and comparisons to national statistics are summarized. RESULTS: Employee turnover within the clinical research professional jobs has decreased from 23% to 16%, a 45% reduction, since the implementation of competency-based job framework. CONCLUSION: The new jobs and career ladders, both of which are centered on a competency-based framework, have decreased the overall turnover rate in this employee population. Since little is known about the rates of turnover in clinical research, especially in the academic medical setting, the results of this analysis can provide important insights to other academic medical centers on both employee turnover rate in general and the potential impact of implementing large-scale competency-based job changes.

Supporting researchers through full-service hotline and consultation services: Success in simplicity, customization, and staffing.

Navigating the research domain at an academic medical center can be challenging, even for seasoned investigators. To address this, Duke University launched two initiatives: (1) a research navigation "hotline" to provide brief assistance with a variety of research questions; and (2) researcher onboarding and consultation, a one-to-one tailored offering to ensure that researchers are equipped to navigate research resources and processes effectively. The services are provided by the myRESEARCHnavigators (MRN) team, funded by Duke's CTSA. The diverse scientific backgrounds of the six team members align well with those of the research community, allowing for a good match between the researcher and MRN team member. The MRN team answers approximately 30 questions per month, and has provided consultations to almost 400 researchers. Both services receive high satisfaction ratings (4 or 5 stars [out of 5 stars] given to 90% of hotline answers, and 99% of researcher onboarding/consultation sessions). As of July 2019, the School of Medicine has determined that the consultations are critical to their mission and have made them a requirement for new research faculty. The team will continue marketing both services to encourage adoption.

Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.

Competency standards for clinical research professionals are being developed across the enterprise, based largely on the Core Competency Framework put forth by the Joint Task Force for Clinical Trial Competency (JTF). In late 2016, representatives from organizations around the world convened at a workshop hosted by the Multi-Regional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss their use of the standards. A number of modifications were suggested that resulted in the publication of JTF Framework 2.0. Another suggested evolution of the Framework was to consider "leveling" the competencies, to reflect the increase in competency that occurs as individuals progress in their careers. This paper describes the process utilized and final outcome of this work. The leveled competencies, defined as the Fundamental, Skilled, and Advanced levels, and the included examples are expected to provide better-defined tools and resources to organizations that are creating educational and training programs, standardized role descriptions, or professional progression planning for clinical research professionals.

Adherence to nicotine replacement therapy among pregnant smokers.

INTRODUCTION: This secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT. METHOD: The analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation. RESULTS: Overall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation. DISCUSSION: Findings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

BACKGROUND: This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation. METHODS: An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum. RESULTS: Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth. CONCLUSIONS: The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.

Physicians' beliefs about discussing obesity: results from focus groups.

PURPOSE: Physicians are expected to discuss weight loss with overweight and obese patients. Physicians' beliefs, outcome expectancies, and strategies for addressing weight with patients have not been examined. DESIGN: Two focus groups of family physicians and internists included questions about obesity and how physicians discuss weight loss with patients. SETTING/SUBJECTS: Family physicians (n = 11) and internists (n = 6) from Duke University Medical Center's Department of Community and Family Medicine and Department of Medicine. ANALYSIS: Qualitative analysis approach using grounded theory methodology. RESULTS: Physicians' responses centered on five key themes: (1) responsibility, (2) barriers, (3) target populations, (4) introducing topic, and (5) ways to talk about obesity. CONCLUSION: Physicians have many barriers related to discussing weight loss with patients. Given the obesity epidemic, the need to understand how to have these discussions, when to have these discussions, and with whom to have these discussions becomes paramount to providing effective care for patients with obesity. Limited physician training in weight-loss counseling explains why physicians find it challenging to discuss obesity with patients.

Retooling institutional support infrastructure for clinical research.

Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a similar transition.