A Method for Efficient De-identification of DICOM Metadata and Burned-in Pixel Text.

De-identification of DICOM images is an essential component of medical image research. While many established methods exist for the safe removal of protected health information (PHI) in DICOM metadata, approaches for the removal of PHI "burned-in" to image pixel data are typically manual, and automated high-throughput approaches are not well validated. Emerging optical character recognition (OCR) models can potentially detect and remove PHI-bearing text from medical images but are very time-consuming to run on the high volume of images found in typical research studies. We present a data processing method that performs metadata de-identification for all images combined with a targeted approach to only apply OCR to images with a high likelihood of burned-in text. The method was validated on a dataset of 415,182 images across ten modalities representative of the de-identification requests submitted at our institution over a 20-year span. Of the 12,578 images in this dataset with burned-in text of any kind, only 10 passed undetected with the method. OCR was only required for 6050 images (1.5% of the dataset).

Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

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.

Now is the time to fix the clinical research workforce crisis.

The clinical and translational research enterprise is recognized by many as the "evidence generation system." While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the "engine" of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even "business as usual" is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that's in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie.

Leveraging retooled clinical research infrastructure for Clinical Research Management System implementation at a large Academic Medical Center.

Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution's ability to measure, control, and respond to metrics of trial performance. Uninformed clinical research provides little benefit to health care, drains institutional resources, and may waste participants' time and commitment. Opportunities for ensuring high-quality research are multifactorial, including training, evaluation, and retention of research workforces; operational efficiencies; and standardizing policies and procedures. Duke University School of Medicine has committed to improving the quality and informativeness of our clinical research enterprise through investments in infrastructure with significant focus on optimizing research management system integration as a foundational element for quality management. To address prior technology limitations, Duke has optimized Advarra's OnCore for this purpose by seamlessly integrating with the IRB system, electronic health record, and general ledger. Our goal was to create a standardized clinical research experience to manage research from inception to closeout. Key drivers of implementation include transparency of research process data and generating metrics aligned with institutional goals. Since implementation, Duke has leveraged OnCore data to measure, track, and report metrics resulting in improvements in clinical research conduct and quality.

Development and implementation of an on-demand competency-based onboarding program for clinical research professionals in academic medicine.

Over the past 7 years, Duke has implemented competency-based job classifications for clinical research professionals (CRPs) with a defined pathway for career advancement. The workforce is defined specifically as the collection of staff employed across the clinical research enterprise to operationalize clinical research and human participatory protocols through the hands-on conduct of protocol activities including participant enrollment, regulatory coordination, study documentation, data collection and management, and sponsor engagement. The competency framework for this critical workforce laid the foundation for a centrally developed on-demand onboarding program at Duke. The self-paced program is designed to engage learners through competency-based learning modules, guided mentor/manager discussions, and applied learning activities. Consisting of an initial E-Learning orientation to clinical research at Duke, called Express Start, followed by a 90-day role-based Onboarding Learning Plan, our onboarding program includes training in foundational pre-defined core competency areas and customizable learning paths. Associated Engagement Activity Packets for many clinical research competencies encourage mentor and/or manager involvement and hands-on learning for the employee through suggested enrichment activities. The program has been widely adopted for CRPs within the Duke University Schools of Medicine and Nursing, and newly hired CRPs and their managers have expressed satisfaction with these centrally offered tools. In this paper, we describe the methods used to develop and implement our competency-based onboarding program. We will share an evaluation of the program and planned next steps for expanding the suite of onboarding resources.

Development and evaluation of a novel training program to build study staff skills in equitable and inclusive engagement, recruitment, and retention of clinical research participants.

Background: Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices. Approach and methods: We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants. Results and discussion: Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

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.

Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards.

INTRODUCTION: Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs). METHODS: SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations. RESULTS: Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures. CONCLUSIONS: The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.

Rural-urban differences in health behaviors and outcomes among older, overweight, long-term cancer survivors in the RENEW randomized control trial.

PURPOSE: Rural cancer survivors (RCS) have poorer health outcomes and face multiple challenges-older age, and limited transportation, education, income, and healthcare access. Yet, RCS are understudied. The Reach-out to ENhancE Wellness(RENEW) trial, a home-based, diet and exercise intervention among 641 breast, prostate, and colorectal cancer survivors addressed many of these challenges. METHODS: We examined whether rural and urban participants differed in their response to the RENEW intervention (e.g., physical functioning, quality-of-life, intakes of fruits and vegetables (F&V) and saturated fat, body mass index(BMI), physical activity, and adverse events). RESULTS: Rural versus urban survivors report significantly more favorable mean (SE) changes in physical functioning [- 0.66 (1.47) v - 1.71 (1.00)], physical health [+ 0.14 (0.71) v - 0.74 (0.50)], and fewer adverse events [1.58 (0.08) v 1.64 (0.06)]. Rural versus urban survivors reported smaller increases in F&Vs [+ 1.47 (0.23) v + 1.56(0.16); p = 0.018], and lower percentages achieved goal behavior for endurance exercise and intakes of F&Vs and saturated fat. CONCLUSIONS: The RENEW intervention reduced declines in physical health and functioning among RCS to a significantly greater extent than for urban cancer survivors. All survivors significantly improved intakes of F&V and saturated fat, and endurance exercise; however, lower percentages of rural versus urban survivors met goal suggesting that more intensive interventions may be needed for RCS.

Effects of diet and exercise on weight-related outcomes for breast cancer survivors and their adult daughters: an analysis of the DAMES trial.

PURPOSE: Few trials have aimed to promote diet and exercise behaviors in both cancer survivors and their family members and examine their associations with weight-related outcomes. We conducted a secondary analysis to examine associations between change in diet and exercise behaviors and weight-related outcomes for overweight breast cancer survivors and their overweight adult daughters in the Daughters And MothErS Against Breast Cancer (DAMES) randomized trial. METHODS: The DAMES trial assessed the impact of two iteratively tailored, mailed print diet and exercise interventions against standard brochures over a 12-month period. This analysis examined change in diet and exercise behaviors and weight-related variables from baseline to post-intervention for the 50 breast cancer survivors and their adult daughters randomized to the intervention arms. To reduce the potential for type II error in this pilot, p values <0.10 were considered statistically significant. RESULTS: For mothers, change in diet quality was uniquely related to change in BMI (ß = -0.12, p = 0.082), weight (ß = -0.12, p = 0.060), and waist circumference (ß = -0.38, p = 0.001), whereas change in caloric intake was related to waist circumference (ß = 0.21, p = 0.002). For daughters, change in caloric intake was related to change in waist circumference (ß = 0.12, p = 0.055). However, change in diet quality was not associated with weight-related outcomes in daughters. Additionally, change in exercise was not associated with weight-related outcomes in mothers or daughters. CONCLUSIONS: Findings support mail-based and other tailored interventions for weight loss in this population, with an emphasis on diet quality for breast cancer survivors and caloric intake for their adult daughters.

Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology.

BACKGROUND: Poor diet and insufficient physical activity are strongly associated with an increased risk of several cancers. Preclinical studies suggest that lifestyle modifications may exert favorable effects on tumor biology. Randomized controlled trials in the presurgical setting serve as an ideal means to translate this research to humans; however, little is known about the characteristics of patients who enroll in these presurgical trials versus those who do not. METHODS: Screening databases from three presurgical lifestyle intervention trials for breast and prostate cancer patients conducted at Duke University Medical Center (NCT00049309) and the University of Alabama at Birmingham (NCT02224807 and NCT01886677) were combined for analysis. Demographic and anthropometric differences between enrolled vs. non-enrolled individuals were assessed using Chi-square for categorical variables and t-tests for continuous variables. RESULTS: There was no difference in participation rate when comparing minority status or overweight and obese patients. However, obese females were slightly more likely to enroll than women who were overweight (p = 0.110), a trend not seen in men. Women were also less likely than men to participate if their study site was >25 miles from their home (p = 0.034). Patients who had completed a college degree were somewhat less likely to enroll than those with less educational attainment (p = 0.072). Of those who did not enroll, 80% cited a lack of time. CONCLUSION: Similar to other clinical trials, lack of time is a leading barrier to enrollment, and travel/distance appears to be a greater barrier for women in presurgical studies. Larger presurgical lifestyle intervention trials will require tailored strategies to enhance recruitment.

Physical resilience of older cancer survivors: An emerging concept.

OBJECTIVES: To characterize factors contributing to physical resilience in older cancer survivors, as demonstrated by resistance to decline or recovery (resilience). MATERIALS AND METHODS: We conducted a secondary analysis of data from a randomized controlled trial of cancer survivors ≥65years old and ≥5years from cancer diagnoses. Physical function was assessed quarterly over 2years, with Short-Form 36 physical function subscale. Participants with ≥2 follow-up assessments (n=594) were evaluated for physical resilience: 1) Resistance was defined as lack of any decline, where decline was a drop of ≥13 points, and 2) resilience (i.e., recovery) was defined as regaining ≥50% of lost function, subsequent to decline. RESULTS: Mean age was 73.1years and 89.1% were Caucasian. Forty-nine percent (n=289) were resistant to decline in function; these individuals were younger, had higher education and income, were more likely to be Caucasian, and had higher baseline physical function (mean difference [MD] 7.8 points, 95% CI 5.0-10.8) and general health (MD 7.5 points, 95% CI 4.9-10.1). Fifty-seven percent (n=137 of 239) demonstrated resilience, with 91.2% (n=125) recovering within 6months of declines; these participants had higher baseline physical function (MD 6.6 points, 95% CI 1.8-11.4), but similar pre-decline function. More participants who were resistant, and more who showed resilience, reported high self-efficacy and social support. CONCLUSIONS: The majority of older cancer survivors exhibited physical resilience; this was associated with high baseline health, physical function, self-efficacy, and social support. Assessing and targeting psychosocial factors may be important for interventions seeking to promote physical resilience.

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.

Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions.

BACKGROUND: The number of older cancer survivors is increasing as more adults survive to older ages. The objectives of this study were to examine trajectories of physical activity (PA) and physical function (PF) over a 2-year lifestyle counseling study and to identify characteristics of the trajectory groups. METHODS: This was a secondary analysis of Reach Out to Enhance Wellness, a randomized controlled trial of home-based lifestyle counseling. The 641 participants were older (≥65 years), overweight (body mass index [BMI], 25 to <40 kg/m(2)), long-term community-dwelling survivors (>5 years) of breast, prostate, and colorectal cancer from Canada, the United Kingdom, and the United States (21 states) who had been randomly assigned to an immediate intervention or a 12-month-wait-listed control arm. The main outcome measures were PA and PF trajectory group membership. RESULTS: Three PA groups and 5 PF trajectory groups were observed. The baseline BMI (P < .001) and self-efficacy for performing strength (P < .0001) and endurance exercises (P < .0002) were the strongest predictors of achieving the highest amount of PA and the most favorable functional trajectory over 2 years. Individuals with low baseline self-efficacy, no PA, and a Short Form 36 PF subscale score < 65 did not benefit from the intervention. CONCLUSIONS: This study identified characteristics of survivors who benefited from home-based interventions and suggested alternative approaches for survivors requiring more structured and intensive interventions to promote behavioral changes.

Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis.

BACKGROUND: The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. METHODS: An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. RESULTS: Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P < .01). All examined predictors were associated with the likelihood of study enrollment (P < .01). No significant predictors of intervention adherence or study completion were found among study enrollees (P ≥ .01). CONCLUSIONS: Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation.

ClinicalTrials.gov reporting: strategies for success at an academic health center.

The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training, and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.

Daughters and Mothers Against Breast Cancer (DAMES): main outcomes of a randomized controlled trial of weight loss in overweight mothers with breast cancer and their overweight daughters.

BACKGROUND: Few studies to date have used the cancer diagnosis as a teachable moment to promote healthy behavior changes in survivors of cancer and their family members. Given the role of obesity in the primary and tertiary prevention of breast cancer, the authors explored the feasibility of a mother-daughter weight loss intervention. METHODS: A randomized controlled trial of a mailed weight loss intervention was undertaken among 68 mother-daughter dyads (n = 136), each comprised of a survivor of breast cancer (AJCC stage 0-III) and her adult biological daughter. All women had body mass indices ≥ 25 kg/m(2) and underwent in-person assessments at baseline, 6 months, and 12 months, with accelerometry and exercise capacity performed on a subset of individuals. All women received a personalized workbook and 6 newsletters over a 1-year period that promoted weight loss; exercise; and a nutrient-rich, low-energy density diet. A total of 25 dyads received individually tailored instruction (individual), 25 dyads received team-tailored instruction (TEAM), and 18 dyads received standardized brochures (control). RESULTS: The trial met its accrual target, experienced 90% retention, and caused no serious adverse events. Significant differences in baseline to 12-month changes were observed between individual versus control mothers for body mass index, weight, and waist circumference (WC); significant differences also were observed in the WC of corresponding daughters (P < .05). Significant differences were found between individual versus control and team versus control dyads for WC (P = .0002 and .018, respectively), minutes per week of physical activity (P = .031 and .036, respectively), and exercise capacity (P = .047 for both). CONCLUSIONS: Significant improvements in lifestyle behaviors and health outcomes are possible with tailored print interventions directed toward survivors of cancer and their family members. For greater impact, more research is needed to expand this work beyond the mother-daughter dyad.

Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors.

BACKGROUND: Diet and exercise interventions for cancer survivors result in health benefits; however, few studies have examined health outcomes in relation to adherence. PURPOSE: We examined associations between adherence to components of a diet-exercise intervention and survivors' physical and mental health. METHODS: A randomized controlled trial tested a telephone and mailed print intervention among 641 older, overweight, long-term survivors of breast, prostate, and colorectal cancer. Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention; health outcomes were examined postintervention. RESULTS: Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior. Attendance showed positive indirect relationships with physical function (ß = 0.11, p < 0.05), basic and advanced lower extremity function (ß = 0.10, p < 0.05/ß = 0.09, p < 0.05), and mental health (ß = 0.05, p < 0.05), and a negative indirect relationship with body mass index (ß = -0.06, p < 0.05). CONCLUSIONS: Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes (Clinicaltrials.gov number NCT00303875).