Relative efficacy of cigarillo warning statements in text and pictorial formats: An experimental study among a sample of US young adults.

INTRODUCTION: Health warning labels (HWLs) communicate the health risks of cigar use and can decrease use when on cigar packages. This study assessed the relative efficacy of six FDA-proposed individual warning statements in text and pictorial format. METHODS: A sample of young adults (ages 18-29) were randomized to a text or pictorial warning condition on generic cigarillo packages. The warning statements were about lung cancer and heart disease; cancers of the mouth and throat; secondhand smoke; not a safe alternative; nicotine/addiction; and harm to baby. Negative emotional reactions, cognitive elaboration, and perceived message effectiveness (PME) were assessed for each warning using linear mixed models. RESULTS: Of the 661 participants, 47.3% reported ever cigarillo smoking, 32.7% current smoking, and 20% were susceptible. In the pictorial format, cancers of the mouth and throat elicited lower levels of anxiety compared to secondhand smoke, not a safe alternative, nicotine/addiction, and harm to baby (ps<0.001). Pictorial HWLs with human imagery induced high anxiety, sadness, fear, and guilt reactions (p<0.001) and higher PME (p=0.011) compared to pictorial HWLs with diseased body parts. Compared to the text HWL cancers of the mouth and throat, the text HWL harm to baby elicited higher anxiety (p=0.003), sadness (p=0.002) and PME (p<0.001). CONCLUSIONS: Pictorial HWLs depicting people or human imagery, rather than images of diseased organs or body parts, to represent health effects elicited the most negative emotional reactions, such as anxiety and guilt, and higher PME. Including such images and texts highlighting effects on vulnerable populations like babies can better communicate cigarillo health risks, aiming to curb cigarillo use among young people. IMPLICATIONS: The study suggests that pictorial health warning labels (HWLs) with human imagery significantly enhance the communication of cigarillo smoking risks compared to images of diseased organs. These HWLs evoke stronger emotional responses, particularly anxiety and guilt, and higher perceived message effectiveness by depicting a recognizable person. Furthermore, text-only warnings describing the smoking effect on vulnerable populations such as babies might have a higher impact on young adults. This evidence supports a strategic shift in FDA policies to include such impactful images and texts, which could potentially lead to a significant reduction in cigarillo use among young people. Our findings underscore the urgent need for continued research and implementation of these enhanced warning labels to improve public health outcomes.

Waterpipe Tobacco Brands and Flavors Sold Online in the USA.

INTRODUCTION: Flavor additives are commonly used in combustible tobacco products to mask harshness and increase appeal. However, research on the availability of flavored waterpipe tobacco (WT) is lacking, yet is important to support implementation of policies. METHODS: We completed a comprehensive online search in 2020 to identify WT brands and flavors sold online in the USA. We conducted a descriptive content analysis categorizing flavors as explicit (i.e., clear taste/flavor) or concept (i.e., no clear taste/flavor); and coded for 23 flavor descriptors (e.g., fruit, mint/menthol, tobacco). Flavor names were double-coded and discrepancies were resolved by a third coder. RESULTS: We identified 66 WT brands with 118 product lines (i.e., sub-brands). We found 2953 flavors, including 1871 unique flavors. Brands averaged 45 flavors (range: 1-183). Almost three quarters (73.5%, n = 2171) used explicit flavor names and 26.5% (n = 782) used concept flavor names. Concept flavors varied widely, and included names such as 1001 Nights and California Dream. The most common flavor descriptors were fruit (54.1%) and mint/menthol (12.5%). Tobacco was rarely (0.2%) used as a flavor descriptor. Flavor descriptors also included location (10.7%), color (11.1%), candy (6.3%), cool/ice (5.3%), and alcohol (5.5%). CONCLUSIONS: WT is available in 1871 unique flavors, likely contributing to product appeal and use. Like other tobacco products, fruit and mint/menthol are common flavors. Given the significant health consequences associated with WT smoking and the role of flavors in product use, regulatory action specifically targeting WT flavors is urgently needed.

Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

BACKGROUND: The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. METHODS: Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. DISCUSSION: We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. CLINICAL TRIAL REGISTRATION: NCT03339440 .

Correction to: Survivorship Care Plan Implementation in US Cancer Programs: a National Survey of Cancer Care Providers.

The original version of this article contained an error. Citation 17 in the original publication referenced the wrong article.

Survivorship Care Plan Implementation in US Cancer Programs: a National Survey of Cancer Care Providers.

Survivorship care plans (SCPs)-documents intended to improve care for cancer survivors who have completed active treatment-are required, yet implementation is poor. We sought to understand SCP implementation in cancer programs in the USA with the objective of identifying opportunities for improvement. We recruited cancer care providers in the USA via several cancer care networks to participate in a survey regarding SCP implementation. We used descriptive statistics to analyze the data. Three hundred ninety-five providers from diverse cancer programs in 47 states and Washington, DC responded to the survey. The timing of SCP implementation varied across and within cancer programs, with approximately 40% of respondents reporting developing SCPs more than 3 months after primary treatment or adjuvant therapy completion. Nurse navigators were responsible for 48-58% of each stage of SCP implementation. Processes that could have been automated often occurred in-person or via phone and vice versa. Respondents reported spending more than 2 h per SCP to complete all stages of implementation, of which less than a third was reimbursed by third-party payers. We identified several opportunities for improving SCP implementation, including broadening the base of responsibility, optimizing modes of communication, decreasing the time required and increasing the funding available, and limiting variation in SCP implementation across and within cancer programs. Future work should assess the influence of approaches to SCP implementation on desired outcomes.

Physical activity and sleep changes among children during the COVID-19 pandemic.

Daily routines, including in-person school and extracurricular activities, are important for maintaining healthy physical activity and sleep habits in children. The COVID-19 pandemic significantly disrupted daily routines as in-person school and activities closed to prevent spread of SARS-CoV-2. We aimed to examine and assess differences in objectively measured physical activity levels and sleep patterns from wearable sensors in children with obesity before, during, and after a period of school and extracurricular activity closures associated with the COVID-19 pandemic. We compared average step count and sleep patterns (using the Mann-Whitney U Test) before and during the pandemic-associated school closures by using data from activity tracker wristbands (Garmin VivoFit 3). Data were collected from 94 children (aged 5-17) with obesity, who were enrolled in a randomized controlled trial testing a community-based lifestyle intervention for a duration of 12-months. During the period that in-person school and extracurricular activities were closed due to the COVID-19 pandemic, children with obesity experienced objectively-measured decreases in physical activity, and sleep duration. From March 15, 2020 to March 31, 2021, corresponding with local school closures, average daily step count decreased by 1655 steps. Sleep onset and wake time were delayed by about an hour and 45 min, respectively, while sleep duration decreased by over 12 min as compared with the pre-closure period. Step counts increased with the resumption of in-person activities. These findings provide objective evidence for parents, clinicians, and public health professionals on the importance of in-person daily activities and routines on health behaviors, particularly for children with pre-existing obesity. Trial Registration: Clinical trial registration: NCT03339440.

A content analysis of cannabis edibles package marketing in the United States.

BACKGROUND: With states legalizing cannabis at a rapid pace, and the increasing popularity of edibles, it is important to document marketing practices to better understand how they might be appealing and misleading to consumers to guide state policymakers. METHODS: A descriptive content analysis of 1229 cannabis edible packages advertised on a publicly available website between June and November 2022 and available for sale in licensed dispensaries was performed. RESULTS: Healthy ingredient descriptors were the most common type of descriptor with 31 % of packages including words like "vegan", "gluten free" and "natural". Quality descriptors like "handcrafted" were on 28 % of packages. Other descriptors were focused on the consumer experience including expected effects (e.g., "relax") (27 %), taste or flavor (e.g., "sour") (21 %) and pharmacokinetics (e.g., "fast-acting") (19 %). Images of non-cannabis plants and outdoor nature settings were on half of packages. Images of the cannabis plant were on 33 % of packages. Flavor imagery including images of food were common (43 %). Other marketing appeals included images of people (15 %), animals (12 %) and space (10 %). CONCLUSIONS: Package marketing used by other commercial industries was common on cannabis edible packages. Edibles marketing is distinct from other cannabis products in its ability to focus on the food ingredients which could mislead consumers into thinking the cannabis, rather than the food, is healthy or less harmful. Research examining the impact of cannabis edibles marketing strategies on appeal and harm perceptions is critically needed to guide policymakers as they establish packaging regulations to optimize public health and safety.

Physical activity and sleep changes among children with obesity during a period of school closures related to the COVID-19 pandemic.

Daily routines, including in-person school and extracurricular activities, are important for maintaining healthy physical activity and sleep habits in children. The COVID-19 pandemic significantly disrupted daily routines as in-person school and activities closed to prevent spread of SARS-CoV-2. We aimed to examine and assess differences in objectively measured physical activity levels and sleep patterns from wearable sensors in children with obesity before, during, and after a period of school and extracurricular activity closures associated with the COVID-19 pandemic. We compared average step count and sleep patterns (using the Mann Whitney U Test) before and during the pandemic-associated school closures by using data from activity tracker wristbands (Garmin VivoFit 3). Data was collected from 94 children (aged 5-17) with obesity, who were enrolled in a randomized controlled trial testing a community-based lifestyle intervention for a duration of 12-months. During the period that in-person school and extracurricular activities were closed due to the COVID-19 pandemic, children with obesity experienced objectively-measured decreases in physical activity, and sleep duration. From March 15, 2020 to March 31, 2021, corresponding with local school closures, average daily step count decreased by 1,655 steps. Sleep onset and wake time were delayed by about an hour and 45 minutes, respectively, while sleep duration decreased by over 12 minutes as compared with the pre-closure period. Step counts increased with the resumption of in-person activities. These findings provide objective evidence for parents, clinicians, and public health professionals on the importance of in-person daily activities and routines on health behaviors, particularly for children with pre-existing obesity. We demonstrate the utility of wearable sensors in objectively measuring longitudinal physical activity and sleep behavior patterns in children with obesity and in quantifying changes in their health behaviors due to disruption of structured, daily routines following in-person school closures during the COVID-19 pandemic. Trial Registration: Clinical trial registration: NCT03339440.

Weight-Related Behaviors of Children with Obesity during the COVID-19 Pandemic.

Background: During the coronavirus disease 2019 (COVID-19) pandemic, children and families have had to adapt their daily lives. The purpose of this study was to describe changes in the weight-related behaviors of children with obesity after the onset of the COVID-19 pandemic. Methods: Semistructured interviews (n = 51) were conducted from April to June 2020 with parents of children with obesity. Families were participants in a randomized trial testing a clinic-community pediatric obesity treatment model. During interviews, families described their experience during the COVID-19 pandemic, with a particular emphasis on children's diet, physical activity, sleep, and screen time behaviors. Rapid qualitative analysis methods were used to identify themes around changes in children's weight-related behaviors. Results: The mean child age was 9.7 (±2.8) years and the majority of children were Black (46%) or Hispanic (39%) and from low-income families (62%). Most parent participants were mothers (88%). There were differences in the perceived physical activity level of children, with some parents attributing increases in activity or maintenance of activity level to increased outdoor time, whereas others reported a decline due to lack of outdoor time, school, and structured activities. Key dietary changes included increased snacking and more meals prepared and consumed at home. There was a shift in sleep schedules with children going to bed and waking up later and an increase in leisure-based screen time. Parents played a role in promoting activity and managing children's screen time. Conclusions: The COVID-19 pandemic has created unique lifestyle challenges and opportunities for lifestyle modification. Clinical Trials ID: NCT03339440.

The Pediatric Obesity Microbiome and Metabolism Study (POMMS): Methods, Baseline Data, and Early Insights.

OBJECTIVE: The purpose of this study was to establish a biorepository of clinical, metabolomic, and microbiome samples from adolescents with obesity as they undergo lifestyle modification. METHODS: A total of 223 adolescents aged 10 to 18 years with BMI ≥95th percentile were enrolled, along with 71 healthy weight participants. Clinical data, fasting serum, and fecal samples were collected at repeated intervals over 6 months. Herein, the study design, data collection methods, and interim analysis-including targeted serum metabolite measurements and fecal 16S ribosomal RNA gene amplicon sequencing among adolescents with obesity (n = 27) and healthy weight controls (n = 27)-are presented. RESULTS: Adolescents with obesity have higher serum alanine aminotransferase, C-reactive protein, and glycated hemoglobin, and they have lower high-density lipoprotein cholesterol when compared with healthy weight controls. Metabolomics revealed differences in branched-chain amino acid-related metabolites. Also observed was a differential abundance of specific microbial taxa and lower species diversity among adolescents with obesity when compared with the healthy weight group. CONCLUSIONS: The Pediatric Metabolism and Microbiome Study (POMMS) biorepository is available as a shared resource. Early findings suggest evidence of a metabolic signature of obesity unique to adolescents, along with confirmation of previously reported findings that describe metabolic and microbiome markers of obesity.

Compliance With US Federal Regulations on Waterpipe Tobacco Warnings on Packaging.

This cohort study reports the rate and degree of compliance with the Food and Drug Administration­mandated warning labels among waterpipe tobacco brands and products.

Middle managers' role in implementing evidence-based practices in healthcare: a systematic review.

BACKGROUND: Middle managers are in a unique position to promote the implementation of evidence-based practices (EBPs) in healthcare organizations, yet knowledge of middle managers' role in implementation and determinants (e.g., individual-, organizational-, and system-level factors) which influence their role remains fractured, spanning decades and disciplines. To synthesize understanding, we undertook a systematic review of studies of middle managers' role in healthcare EBP implementation and determinants of that role. METHODS: We searched MEDLINE/PubMed and Business Source Complete (Ebsco) for literature on middle managers' role in healthcare EBP implementation and its determinants. We abstracted data from records that met inclusion criteria (i.e., written in English, peer-reviewed, and reporting either a protocol or results of an empirical study) into a matrix for analysis. We summarized categorical variables using descriptive statistics. To analyze qualitative data, we used a priori codes and then allowed additional themes to emerge. RESULTS: One hundred five records, spanning across several countries and healthcare settings and relating to a range of EBPs, met our inclusion criteria. Studies of middle managers' role in healthcare EBP implementation and its determinants substantially increased from 1996 to 2015. Results from included studies suggest that middle managers shape implementation climate in addition to fulfilling the four roles hypothesized in extant theory of middle managers' role in implementation. However, extant studies offered little understanding of determinants of middle managers' role. CONCLUSIONS: Our findings suggest that middle managers may play an important role in facilitating EBP implementation. Included studies offered little understanding regarding the relative importance of various roles, potential moderators of the relationship between middle managers' roles and EBP implementation, or determinants of middle managers' role in EBP implementation. Future studies should seek to understand determinants and moderators of middle managers' role. Clearer understanding may facilitate the translation of evidence into practice.

Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

PURPOSE: The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes. METHODS: We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes. RESULTS: RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives. CONCLUSIONS: RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders. IMPLICATIONS FOR CANCER SURVIVORS: SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.