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.

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.

A community-based intervention increases physical activity and reduces obesity in school-age children in North Carolina.

BACKGROUND: Community-based interventions are promising approaches to obesity prevention, but few studies have prospectively evaluated them. The aim of this study was to evaluate a natural experiment­a community intervention designed to promote active living and decrease obesity within a small southern town. METHODS: In 2011, community leaders implemented the Mebane on the Move intervention­a community-wide effort to promote physical activity (PA) and decrease obesity among residents of Mebane, North Carolina. We measured child PA and BMI before and after the intervention, using a nearby town not implementing an intervention as the comparison. In total, we assessed 64 children from Mebane and 40 from the comparison community 6 months before, as well as 34 and 18 children 6 months after the intervention. We assessed PA with accelerometers worn for 7 days and calculated BMI z-scores using children's height and weight. We conducted multivariable linear regressions examining pre- to postintervention change in minutes of PA and BMI z-score, adjusting for confounders. RESULTS: At follow-up, children in Mebane modestly increased their moderate-to-vigorous PA (1.3 minutes per hour; 95% confidence interval (CI): 0.2, 2.3; p=0.03) and vigorous activity (0.8 minutes per hour; 95% CI: 0.1, 1.5; p=0.04) more than comparison children. In intervention children, BMI z-scores decreased 0.5 units (kg/m(2); 95% CI: -0.9, -0.02; p=0.045), compared to children in the comparison community. CONCLUSIONS: We observed positive effects on PA level and weight status of children in Mebane, despite high rates of attrition, suggesting that the community-based intervention may have been successful.

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.

The keys to healthy family child care homes intervention: study design and rationale.

BACKGROUND: Obesity is a major public health problem for which early preventive interventions are needed. Large numbers of young children are enrolled in some form of child care program, making these facilities influential environments in children's development. Family child care homes (FCCH) are a specific type of child care in which children are cared for within the provider's own residence. FCCHs serve approximately 1.5 million children in the U.S.; however, research to date has overlooked FCCH providers and their potential to positively influence children's health-related behaviors. METHODS: Keys to Healthy Family Child Care Homes (Keys) is a cluster-randomized controlled trial testing the efficacy of an intervention designed to help providers become healthy role models, provide quality food- and physical activity-supportive FCCH environments, and implement effective business practices. The intervention is delivered through workshops, home visits, tailored coaching calls, and educational toolkits. Primary outcomes are child physical activity measured via accelerometry data and dietary intake data collected using direct observation at the FCCH. Secondary outcomes include child body mass index, provider weight-related behaviors, and observed obesogenic environmental characteristics. CONCLUSION: Keys is an innovative approach to promoting healthy eating and physical activity in young children. The intervention operates in a novel setting, targets children during a key developmental period, and addresses both provider and child behaviors to synergistically promote health.

Physical activity-related and weather-related practices of child care centers from 2 states.

BACKGROUND: Young children's physical activity (PA) is influenced by their child care environment. This study assessed PA practices in centers from Massachusetts (MA) and Rhode Island (RI), compared them to best practice recommendations, and assessed differences between states and center profit status. We also assessed weather-related practices. METHODS: Sixty percent of MA and 54% of RI directors returned a survey, for a total of 254. Recommendations were 1) daily outdoor play, 2) providing outdoor play area, 3) limiting fixed play structures, 4) variety of portable play equipment, and 5) providing indoor play area. We fit multivariable linear regression models to examine adjusted associations between state, profit status, PA, and weather-related practices. RESULTS: MA did not differ from RI in meeting PA recommendations (ß = 0.03; 0.15, 0.21; P = .72), but MA centers scored higher on weather-related practices (ß = 0.47; 0.16, 0.79; P = .004). For-profit centers had lower PA scores compared with nonprofits (ß = -0.20; 95% CI: -0.38, -0.02; P = .03), but they did not differ for weather (ß = 0.12; -0.19, 0.44; P = .44). CONCLUSIONS: More MA centers allowed children outside in light rain or snow. For-profit centers had more equipment­both fixed and portable. Results from this study may help inform interventions to increase PA in children.

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.

Postpartum physical activity in overweight and obese women.

BACKGROUND: Low physical activity (PA) during the postpartum period is associated with weight retention. While patterns of PA have been examined in normal weight women during this period, little is known about PA among overweight and obese women. The aim of this cross-sectional study was to investigate PA and determine the proportion of women meeting recommendations for PA. METHODS: Women (n = 491), with a body mass index (BMI) ≥ 25 kg/m² were enrolled in a behavioral intervention. PA was assessed at six weeks postpartum using the Seven-Day PA Recall. RESULTS: Women averaged 923 ± 100 minutes/day of sedentary/ light and 33 ± 56 minutes/day of combined moderate, hard, and very hard daily activity. Women with a BMI ≥ 40 kg/m² reported more time in sedentary/light activities and less hours of sleep than those with a lower BMI. Only 34% met national PA guidelines; this proportion was significantly lower among blacks (OR 0.5, CI 0.3-0.9). CONCLUSIONS: These overweight and obese postpartum women reported a large percentage of time spent in sedentary/light activity, and a high proportion failed to meet minimal guidelines for PA. Promotion of PA in the postpartum period should focus on reducing sedentary behaviors and increasing moderate PA.

Multiparity is associated with high motivation to change diet among overweight and obese postpartum women.

BACKGROUND: Pregnancy is associated with weight gain and obesity. The aim of this study was to identify the effect of parity and other factors on motivation to change diet to lose weight in a cohort of overweight and obese postpartum women. STUDY DESIGN: Active Mothers Postpartum is a randomized, controlled trial aimed at postpartum weight reduction. At baseline, we measured motivation to change diet to lose weight among 491 overweight/obese postpartum women. Logistic regression was used to model the effect of parity on motivation to change diet at baseline while adjusting for potential confounders including age, race, education, body mass index category, and breastfeeding status. RESULTS: Approximately two thirds (68%) of participants were highly motivated to change their diet to lose weight. In the multivariable model, women with three or more children had 2.5 times the odds of high motivation compared with primigravid women, and women not breastfeeding had 1.6 times the odds of high motivation compared with any breastfeeding. CONCLUSION: Although risk for obesity is incurred starting with a woman's first pregnancy, women in this study were more motivated to change their diet to lose weight after their third pregnancy. Further research is needed to understand how to best capitalize on the high motivation in women with several children as well as how to improve motivation for primigravid women and women who are breastfeeding.

Primary care physicians' discussions of weight-related topics with overweight and obese adolescents: results from the Teen CHAT Pilot study.

Physicians should counsel overweight adolescents about nutrition and exercise. We audio recorded 30 physician-adolescent encounters. Female, older, normal-weight physicians and pediatricians were more Motivational Interviewing (MI) adherent. When physicians used MI skills, patients increased exercise, lost weight, and reduced screen time. Physicians should use MI techniques to help adolescents change.

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.

Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial.

Improvements in smoking cessation interventions for pregnant smokers are needed. One major step is to examine the potential effectiveness of nicotine replacement therapy (NRT). The potential benefits of providing pregnant women with NRT to help them quit smoking are still unknown; early interventions to test the effectiveness and efficacy are vital to advancing the field. This paper describes recruitment efforts for a multiclinic trial to test the effectiveness of NRT use in addition to behavioral therapy in promoting cessation during pregnancy. The biggest challenge is recruiting sufficient numbers of pregnant women. This paper discusses specific obstacles for recruitment and solutions. Knowing the potential pitfalls to recruiting pregnant women into these trials can lead to better studies and thus improved outcomes.

Weight and smoking cessation among low-income African Americans.

BACKGROUND: Concerns about weight gain have been a commonly cited barrier to cessation among white, affluent, female populations, but less is known about this relationship among minority smokers and those with low incomes. Although smoking cessation is strongly encouraged for this population, it often leads to weight gain. Cultural differences in weight standards and the high prevalence of weight-related health conditions (e.g., hypertension and diabetes) may influence concerns about smoking cessation-related weight gain. METHODS: A secondary analysis of low-income African-American smokers (n=367) from a randomized intervention trial was conducted to explore the association of weight concerns with comorbidities and smoking cessation. RESULTS: Less than one quarter of participants were considered concerned about weight, defined as having high general concern about weight and high expectation of post-cessation weight gain. Those for whom weight gain could be riskiest--obese participants--were least concerned about gaining weight. Further, weight concerns were not associated with successful smoking cessation, quit attempts, confidence in quitting, or desire or readiness to quit. CONCLUSIONS: Because post-cessation weight gain may be a serious health threat for this population, but weight gain was not a concern for these smokers, smoking-cessation interventions for low-income African-American smokers may need to incorporate weight-gain education and prevention.

Prolonged nicotine patch use in quitters with past abstinence-induced depressed mood.

To test the efficacy of sustained nicotine patch use among at-risk smokers, 55 smokers with a history of abstinence-induced depressed mood were randomly assigned to either Nicotine Maintenance or Standard Treatment following preliminary high-dose patch treatment. The Nicotine Maintenance group received 21 mg transdermal nicotine for 8 additional weeks; the Standard Treatment group followed a tapered dosing regimen. Significant differences favoring the Nicotine Maintenance group were found in self-reported craving but not withdrawal. No difference was observed in continuous abstinence or in relapse rates. When dropouts who did not relapse during patch use were classified as successful, however, the Nicotine Maintenance group had significantly lower relapse rates. Rate of lapse in the Nicotine Maintenance group during post-trial tapering did not differ significantly from that in the Standard Treatment group during tapering in the trial, suggesting that the benefits of sustained dosing may persist only as long as dosing continues.