Training the Next Generation of Local Public Health Leaders: A Case Study of Community Health Organizers in Pennsylvania.

Few short-term training programs exist for persons with limited experience or training in public health to support public health initiatives. We describe a public health training designed by the Pennsylvania (PA) Training Center for Health Equity for the PA Community Health Organizer (CHO) program. The CHO program was created to address the immediate needs of underserved communities and promote lasting health equity during the pandemic. CHOs are professionals who promote community action and align efforts with local organizations to build sustainable public health infrastructure and apply evidence-based practices to program policy, planning, and development. The training content, delivered by Project Extension for Community Healthcare Outcomes (ECHO) in 12 monthly sessions, focused upon foundational public health concepts in a novel community case study approach. The ECHO All Teach, All Learn training model was successful in providing relevant public health information to this new workforce, and the pre-/post-training evaluation demonstrated a positive increase in knowledge across all domains.

Effects of liquid nicotine concentration and flavour on the acceptability of electronic nicotine delivery systems (ENDS) among people who smoke participating in a randomised controlled trial to reduce cigarette consumption.

BACKGROUND: Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking. METHODS: People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction. RESULTS: Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups. CONCLUSIONS: Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

Trends in Calcium Intake among the US Population: Results from the NHANES (1999-2018).

Inadequate calcium intake is common in the US. Trends in calcium intake among the US population have been less studied, especially in more recent years. We used data from the National Health and Nutrition Examination Survey (NHANES) 1999-2000 to 2017-2018 to study trends in calcium derived from diet and dietary supplements among the US population aged 2 years, stratified by sex, age group, race, and ethnicity. Among the 80,880 participants included in our study, a substantial portion consistently lacked sufficient calcium intake, even when considering calcium from supplements. Concerning trends were observed over the more recent ten years (2009-2018), with decreased dietary calcium intake and no significant improvement in the prevalence of dietary calcium intake < Estimated Average Requirement (EAR) or the prevalence of taking calcium-containing dietary supplements among them. Decreasing trends in dietary calcium intake were more concerning among men, children, and non-Hispanic Whites. Attention should be given to subgroups with higher calcium intake requirements (e.g., 9-18 years and 60+ years), and subgroups with low levels of dietary calcium and a low prevalence of obtaining calcium from dietary supplements (e.g., the non-Hispanic Black subgroup). Concerning trends of calcium intake were observed among the US population from 2009 to 2018. Tailored guidance on dietary choices and dietary supplement use is required to change consumers' behaviors.

Growing Healthy Hearts: a single-arm feasibility study of a digitally delivered gardening, cooking, and nutrition intervention for adults with risk factors for cardiovascular disease.

BACKGROUND: Food gardening may positively influence cardiovascular disease (CVD) risk-related behaviors. However, the vast majority of existing gardening interventions have used an in-person delivery model which has limitations for scalability. It is not known whether a digitally delivered gardening intervention would be feasible or acceptable to participants. The purpose of this pilot study was to assess the feasibility of a digitally delivered gardening intervention in three domains: participant acceptability, demand, and practicality. METHODS: A single-arm, pre-post-study design was used. Participants (n = 30) were aged 20 + with no plans to garden in the coming season and had at least 1 CVD risk factor. The intervention included ten 1-h video-conferencing sessions, written materials, and access to a study website. Content focused on gardening skills, cooking skills, and the Dietary Approaches to Stop Hypertension (DASH) diet. Feasibility outcomes included acceptability (post-program ratings), demand (session attendance rate), and practicality (ability to start a garden and grow F&V). The study was considered feasible if the following criteria were met: ≥ 70% rated the intervention as good or excellent, overall session attendance rate was ≥ 70%, and > 70% were able to start a garden and grow F&V. We also assessed pre-post-program changes in behavioral mediators (gardening confidence, gardening enjoyment, cooking confidence, and nutrition knowledge). Descriptive statistics were calculated. Pre-post differences were evaluated with means and 95% confidence intervals (95% CI). Effect sizes were calculated (Cohen's d). RESULTS: All feasibility criteria were met. A total of 93.3% of participants rated the intervention as good or excellent, 96% started a garden and grew F&V, and the overall session attendance rate was 81%. The largest mean pre-post changes were in gardening confidence (pre 7.1 [95% CI: 6.4, 7.9], post 9.0 [95% CI: 8.6, 9.5], Cohen's d = 1.15), gardening enjoyment (pre: 6.3 [95% CI: 5.9, 6.7], post: 7.5 [95% CI: 7.1, 7.9], Cohen's d = 1.69), and cooking self-efficacy (pre: 4.7 [95% CI: 4.3, 5.1], post: 7.7 [95% CI: 7.3, 8.0], Cohen's d = 3.0). CONCLUSION: A digitally delivered gardening intervention was feasible, acceptable to participants, and they had meaningful changes in behavioral mediators. The next step is to evaluate the impact of the intervention in a future randomized controlled trial.

Participant Preferences for the Development of a Digitally Delivered Gardening Intervention to Improve Diet, Physical Activity, and Cardiovascular Health: Cross-sectional Study.

BACKGROUND: Low dietary intake of fruits and vegetables and physical inactivity are 2 modifiable risk factors for cardiovascular disease. Fruit and vegetable gardening can provide access to fresh produce, and many gardening activities are considered moderate physical activity. This makes gardening interventions a potential strategy for cardiovascular disease risk reduction. Previously developed gardening interventions have relied on in-person delivery models, which limit scalability and reach. OBJECTIVE: The purpose of this study was to ascertain participant insight on intervention components and topics of interest to inform a digitally delivered, gardening-focused, multiple health behavior change intervention. METHODS: A web-based survey was delivered via Amazon Mechanical Turk (MTurk), including quantitative and open-ended questions. Eligible participants were aged ≥20 years, could read and write in English, were US residents, and had at least a 98% MTurk task approval rating. A multilevel screening process was used to identify and exclude respondents with response inattention, poor language fluency, or suspected automated web robots (bots). Participants were asked about their interest in gardening programming, their preferences for intervention delivery modalities (1-hour expert lectures, a series of brief <5-minute videos, or in-person meetings), and what information is needed to teach new gardeners. Comparisons were made between never gardeners (NG) and ever gardeners (EG) in order to examine differences in perceptions based on prior experience. Quantitative data were summarized, and differences between groups were tested using chi-square tests. Qualitative data were coded and organized into intervention functions based on the Behavior Change Wheel. RESULTS: A total of 465 participants were included (n=212, 45.6% NG and n=253, 54.4% EG). There was a high level of program interest overall (n=355, 76.3%), though interest was higher in EG (142/212, 67% NG; 213/253, 84.2% EG; P<.001). The majority of participants (n=282, 60.7%) preferred a series of brief <5-minute videos (136/212, 64.2% NG; 146/253, 57.7% EG; P=.16) over 1-hour lectures (29/212, 13.7% NG; 50/253, 19.8% EG; P=.08) or in-person delivery modes (47/212, 22.2% NG; 57/253, 22.5% EG; P=.93). Intervention functions identified were education and training (performing fundamental gardening and cooking activities), environmental restructuring (eg, social support), enablement (provision of tools or seeds), persuasion (offering encouragement and highlighting the benefits of gardening), and modeling (using content experts and participant testimonials). Content areas identified included the full lifecycle of gardening activities, from the fundamentals of preparing a garden site, planting and maintenance to harvesting and cooking. CONCLUSIONS: In a sample of potential web-based learners, participants were interested in a digitally delivered gardening program. They preferred brief videos for content delivery and suggested content topics that encompassed how to garden from planting to harvesting and cooking. The next step in this line of work is to identify target behavior change techniques and pilot test the intervention to assess participant acceptability and preliminary efficacy.

Gardening Is Associated With Better Cardiovascular Health Status Among Older Adults in the United States: Analysis of the 2019 Behavioral Risk Factor Surveillance System Survey.

BACKGROUND: Gardening benefits health in older adults, but previous studies have limited generalizability or do not adequately adjust for sociodemographic factors or physical activity (PA). OBJECTIVE: We examined health outcomes, fruits and vegetables (F&V) intake, and 10-year mortality risk among gardeners and exercisers compared with nonexercisers. DESIGN: Cross-sectional data of noninstitutionalized US adults in the 2019 Behavioral Risk Factor Surveillance System was collected via landline and cellular phone survey. PARTICIPANTS/SETTING: Adults 65 years and older reporting any PA (n = 146,047) were grouped as gardeners, exercisers, or nonexercisers. MAIN OUTCOME MEASURES: Outcomes included cardiovascular disease (CVD) risk factors, mental and physical health, F&V intake, and 10-year mortality risk. STATISTICAL ANALYSES: Summary statistics were calculated and adjusted logistic regression models were conducted to calculate adjusted odds ratios (aORs) and 95% CIs, accounting for the complex survey design. RESULTS: The sample included gardeners (10.2%), exercisers (60.0%), and nonexercisers (30.8%). Gardeners, compared with nonexercisers, had significantly lower odds of reporting all studied health outcomes and higher odds of consuming 5 or more F&V per day (CVD: aOR 0.60, 95% CI 0.53 to 0.68; stroke: aOR 0.55, 95% CI 0.47 to 0.64; heart attack: aOR 0.63, 95% CI 0.55 to 0.73, high cholesterol: aOR 0.86, 95% CI 0.79 to 0.93; high blood pressure: aOR 0.74, 95% CI 0.68 to 0.81; diabetes: aOR 0.51, 95% CI 0.46 to 0.56; body mass index ≥25: aOR 0.74, 95% CI 0.68 to 0.80; poor mental health status: aOR 0.50, 95% CI 0.43 to 0.59; poor physical health status: aOR 0.35, 95% CI 0.31 to 0.39; 5 or more F&V per day: aOR 1.56, 95% CI 1.40 to 1.57; high 10-year mortality risk: aOR 0.39, 95% CI 0.36 to 0.42). Male and female gardeners had significantly lower odds of reporting diabetes even when compared with exercisers. CONCLUSIONS: Among adults 65 years and older, gardening is associated with better CVD health status, including lower odds of diabetes. Future longitudinal or interventional studies are warranted to determine whether promoting gardening activities can be a CVD risk reduction strategy.

Influence of social and behavioral determinants on health-related quality of life among cancer survivors in the USA.

PURPOSE: Cancer survivors experience a worse health-related quality of life (HRQoL) than non-cancer survivors. However, it is not fully understood whether social determinants of health (SDOH) and health behaviors are significantly associated with HRQoL among cancer survivors. The purpose of this study was to investigate the influence of SDOH and health behaviors on HRQoL among cancer survivors. METHODS: We identified adult (18 years or older) cancer survivors (n = 5784) in the 2017 and 2019 Behavioral Risk Factor Surveillance System. The primary outcome (HRQoL) was defined as whether cancer survivors reported having poor mental or physical health (e.g., 14 or more mentally or physically unhealthy days). Unadjusted and adjusted logistic regression was used to compute the odds ratios and 95% CIs of factors associated with poor HRQoL among the cancer survivors. RESULTS: More than half of the cancer survivors were non-Hispanic White, female, and 65 years or older. In the adjusted multivariable logistic regression models, cancer survivors who were physically active and who did not avoid care because of costs had a lower risk of poor mental and physical health. Current smokers were more likely to report poor physical health. Homeowners were less likely to report poor mental health. Daily fruit and vegetable consumption and healthcare coverage were not associated with poor HRQoL. CONCLUSIONS: Some SDOH (healthcare access, economic stability, and the neighborhood and built environment) and health behavior (physical activity) are associated with lower likelihood of experiencing poor mental and/or physical health in the cancer survivors. The study findings can be used to target survivors who experience suboptimal HRQoL and to inform research, public health policies, and/or programs.

The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial.

BACKGROUND: The U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the potential effects of this regulation in smokers with affective disorders. METHODS: In a randomized controlled parallel group trial conducted at two sites in the USA (Penn State University, Hershey, PA and Massachusetts General Hospital, Boston, MA) 188 adult smokers with a current (n = 118) or lifetime (n = 70) anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned (1:1) to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) research cigarettes, or Reduced Nicotine Content (RNC) research cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. The pre-registered primary outcome was plasma cotinine. RESULTS: A total of 143 (76.1%) randomized participants completed the randomized phase of the trial, 69 (73.4%) in the RNC group and 74 (78.8%) in the UNC group. After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, at the last randomized visit the RNC group had significantly lower plasma cotinine (metabolite of nicotine): difference between groups, -175.7, 95% CI [-218.3, -133.1] ng/ml. Urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence were also significantly lower in the RNC group than the UNC group. No between-group differences were found on a range of other biomarkers (e.g. 8-isoprostanes) or health indicators (e.g. blood pressure), or on 5 different psychiatric questionnaires, including the Kessler K6 measure of psychological distress. At the end of the subsequent 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking, based on initial intent-to-treat sample, n = 188 (18.1% RNC v 4.3% UNC, p = 0.004). CONCLUSION: Reducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health. TRIAL REGISTRATION: TRN: NCT01928758, registered August 21, 2013.

A cluster-randomized controlled trial of automated internet weight-loss programs in primary care: Role of automated provider feedback.

OBJECTIVE: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity. METHODS: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months. RESULTS: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP. CONCLUSIONS: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence.

Strategies to Help Health Care Organizations Execute Their Food System Leadership Responsibilities.

Food systems influence environmental sustainability and health. The fact that our current food production and distribution practices neither support nor promote planetary or human health raises ethical concerns. Since health organizations offer food to patients, community members, and employees, they are situated at key intersections among food systems, agricultural policies and practices, and public health. This article considers the nature and scope of health care organizations' local food system leadership responsibilities and describes how health care organizations' food practices can help improve health outcomes and motivate equity.

Pilot randomized controlled trial evaluating the effect of random nicotine delivery on cigarettes per day and smoke exposure.

BACKGROUND: Many smokers report attempting to quit each year, yet most relapse, in part due to exposure to smoking-related cues. It is hypothesized that extinction of the cue-drug association could be facilitated through random nicotine delivery (RND), thus making it easier for smokers to quit. The current study aimed to evaluate the effects of RND on smoking cessation-related outcomes including cigarettes per day (CPD) and exhaled carbon monoxide (CO). METHODS: Participants were current smokers (>9 CPD) interested in quitting. Novel trans-mucosal, orally dissolving nicotine films, developed by Bionex Pharmaceuticals, were used in the study. The pharmacokinetic profile of these films was assessed in single (Experiment 1) and multiple-dose (Experiment 2) administrations prior to the smoking cessation study (Experiment 3). In Experiment 3, participants were randomized 1:1:1 to recieve 4 nicotine films per day of either: placebo delivery (0 mg), steady-state delivery (2 mg), or random nicotine delivery (RND) (0 mg or 4 mg). After two weeks, participants were advised to quit (target quit date, TQD) and were followed up 4 weeks later to collect CPD and CO and to measure dependence (Penn State Cigarette Dependence Index; PSCDI) and craving (Questionnaire of Smoking Urges; QSU-Brief). Means and frequencies were used to describe the data and repeated measures ANOVA was used to determine differences between groups. RESULTS: The pharmacokinetic studies (Experiment 1 and 2) demonstrated that the films designed for this study delivered nicotine as expected, with the 4 mg film delivering a nicotine boost of approximately 12.4 ng/mL across both the single and the multiple dose administration studies. The films reduced craving for a cigarette and were well-tolerated, overall, and caused no changes in blood pressure or heart rate. Using these films in the cessation study (Experiment 3) (n = 45), there was a significant overall reduction in cigarettes smoked per day (CPD) and in exhaled CO, with no significant differences across groups (placebo, steady-state, RND). In addition, there were no group differences in dependence or craving. Adverse events included heartburn, hiccups, nausea, and to a lesser extent, vomiting and anxiety and there were no differences across groups. CONCLUSION: Overall, this pilot study found that RND via orally dissolving films was feasible and well tolerated by participants. However, RND participants did not experience a greater reduction in self-reported CPD and exhaled CO, compared with participants in the steady-state and placebo delivery groups. Future studies to evaluate optimal RND parameters with larger sample sizes are needed to fully understand the effect of RND on smoking cessation-related outcomes.

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients.

Continued smoking after a cancer diagnosis is causally associated with increased risks of all-cause and cancer-specific mortality, and of smoking-related second primary cancers. Patient navigation provides individualized assistance to address barriers to smoking cessation treatment and represents a promising bridge to smoking cessation in persons with cancer who smoke cigarettes. We conducted a single-arm interventional cohort study of current smokers identified through prospective health record screening and recruited from Penn State Cancer Institute outpatient clinics. Consented participants received two telephone intervention sessions and gain-framed messaging-based smoking cessation educational materials designed for persons with cancer. The primary study outcome was the feasibility of the patient navigation-based intervention; the secondary outcome was the engagement in smoking cessation treatment at the two-month follow-up. Of 1168 unique screened Cancer Institute patients, 134 (11.5%) were identified as current cigarette smokers. Among 67 patients approached at outpatient clinics, 24 (35.8%) were interested in participating, 12 (17.9%) were enrolled, eight (11.9%) completed the intervention sessions and study assessments, and six engaged in smoking cessation treatment. The participants expressed satisfaction with the intervention sessions (median = 8.5, scale 0-10). The low recruitment rates preclude patient navigation as a feasible method for connecting cancer patients to smoking cessation treatment resources.

Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers With No Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial.

INTRODUCTION: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking is unclear. This exploratory analysis examined the effects of ENDS delivering different amounts of nicotine on cigarette abstinence up to 24-week follow-up, in comparison to placebo or a behavioral substitute. METHODS: This four-arm parallel-group, randomized, placebo-controlled trial took place at two academic medical centers in the United States (Penn State Hershey and Virginia Commonwealth University). Participants were current adult smokers (N = 520) interested in reducing but not planning to quit. They received brief advice and were randomized to one of four 24-week conditions, receiving either an eGo-style ENDS paired with 0, 8, or 36 mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS). Self-reported daily cigarette consumption and exhaled carbon monoxide (CO) were measured at all study visits. Outcomes included intent-to-treat, self-reported 7-day cigarette abstinence, biochemically confirmed by exhaled CO at 24 weeks after randomization. RESULTS: At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI = 1.9-104.9] and 3.5 [95% CI = 1.2-10.4], respectively). The abstinence rate in the 8 mg/ml condition was 4.6% (6/130). CONCLUSIONS: When smokers seeking to reduce smoking tried ENDS, few quit smoking in the short term. However, if smokers continued to use an ENDS with cigarette-like nicotine delivery, a greater proportion completely switched to ENDS, as compared with placebo or a cigarette substitute. IMPLICATIONS: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking was unclear. This randomized trial found that ENDS with nicotine delivery approaching that of a cigarette are more effective in helping ambivalent smokers to quit cigarette smoking.

Impact of a Prescription Produce Program on Diabetes and Cardiovascular Risk Outcomes.

OBJECTIVE: To evaluate the impact of a fruit and vegetable prescription program on diabetes and cardiovascular risk outcomes. DESIGN: Single-arm pre-post study. SETTING: Primary care clinic in a community-based hospital. PARTICIPANTS: Adults with type 2 diabetes (n = 97), aged > 18 years, with hemoglobin A1c (HbA1c) ≥ 7.0%, and a body mass index (BMI) of ≥ 25 kg/m2. INTERVENTION: Over 7 months, participants received monthly group-based diabetes self-management education (DSME) and monthly vouchers ($28-$140/month) redeemable for fruits and vegetables at local markets. ANALYSIS: Biomarker changes (HbA1c, BMI, and blood pressure) were assessed with paired t tests. Voucher distribution and redemption were tracked, and voucher redemption rates were calculated. Linear mixed-effect regression models tested associations between biomarkers, voucher redemption rates, and participant characteristics. RESULTS: There was a -1.3% (P < 0.001) postprogram change in HbA1c. Reduced HbA1c was associated with higher voucher redemption rates (P = 0.032) and a change in diabetes medications (P = 0.003). There were no associations with BMI, but blood pressure was positively associated with voucher redemption. CONCLUSIONS AND IMPLICATIONS: Fruit and vegetable prescription programs may improve diabetes outcomes by incentivizing DSME uptake and retention. Future randomized trials are warranted to identify strategies to improve DSME engagement and voucher redemption rates and assess mechanisms through which these programs influence health outcomes.

Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial.

BACKGROUND: Electronic nicotine delivery systems (ENDSs) are used by some smokers to reduce cigarette consumption, but their effectiveness is uncertain. We aimed to examine the extent to which ENDSs or a non-nicotine cigarette substitute influence tobacco-related toxicant exposure and cigarette consumption in smokers interested in smoking reduction. METHODS: We did a four-arm, parallel-group, randomised controlled trial at two sites in the USA (Penn State University, Hershey, PA, and Virginia Commonwealth University, Richmond, VA). We enrolled adults aged 21-65 years who smoked more than nine cigarettes per day (for at least the past year), with exhaled CO of more than 9 parts per million at screening, who were not currently using an ENDS, and who were interested in reducing smoking but not quitting. Participants were randomised (site-specific with allocation concealment; 1:1:1:1) to receive either a cartomiser-based, pen-style ENDS (eGo-style) paired with 0, 8, or 36 mg/mL liquid nicotine (participants and researchers masked to concentration) or a non-ENDS cigarette-shaped plastic tube that delivered no nicotine or aerosol (cigarette substitute; unmasked) for 24 weeks. Conditions were chosen to reflect a range of nicotine delivery including none (cigarette substitute and 0 mg/mL ENDS), low (8 mg/mL), and cigarette-like (36 mg/mL), and all conditions were paired with smoking reduction instructions. The primary outcome was concentration of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; urinary total) collected at randomisation and at 4, 12, and 24 weeks. Multiple imputation with and without covariate adjustment was used in addition to sensitivity analyses. This trial is registered with ClinicalTrials.gov, NCT02342795. FINDINGS: Between July 22, 2015, and Nov 16, 2017, 684 individuals were screened and 520 (76%) were enrolled and randomised. 188 (36%) of 520 participants were lost to follow-up by week 24; attrition did not differ by study group (39 [30%] of 130 in the cigarette substitute group, 56 [43%] of 130 in the ENDS with 0 mg/mL nicotine group, 49 [38%] of 130 in the ENDS 8 mg/mL group, and 44 [34%] of 130 in the ENDS 36 mg/mL group). Urinary total NNAL at 24 weeks in the ENDS with 36 mg/mL nicotine group was 210·80 pg/mg creatinine (95% CI 163·03-274·42) compared with 346·09 pg/mg creatinine (265·00-455·32) in the cigarette substitute group (p=0·0061). No other significant differences between groups were observed for any time point for urinary total NNAL. Serious adverse event frequency was similar across groups (12 events in 12 participants [9%] in the ENDS with 36 mg/mL nicotine group, seven events in six participants [5%] in the 8 mg/mL group, 11 events in ten participants [8%] in the 0 mg/mL group, and 13 events in 13 participants [10%] in the cigarette substitute group), and all of these were deemed unrelated or unlikely to be related to study product use. There was one death between randomisation and 24 weeks (suicide; in the ENDS with 0 mg/mL nicotine group). INTERPRETATION: Use of an ENDS with cigarette-like nicotine delivery can reduce exposure to a major pulmonary carcinogen, NNAL, even with concurrent smoking. Future ENDS trials should involve products with well characterised nicotine delivery, including those with nicotine delivery approaching that of a cigarette. FUNDING: National Institutes of Health, US Food and Drug Administration.

Alcohol consumption and risk of cardiovascular disease, cancer and mortality: a prospective cohort study.

BACKGROUND: Studies regarding whether light to moderate alcohol consumption is associated with a lower risk of cardiovascular diseases (CVD) have generated mixed results. Further, few studies have examined the potential impact of alcohol consumption on diverse disease outcomes simultaneously. We aimed to prospectively study the dose-response association between alcohol consumption and risk of CVD, cancer, and mortality. METHODS: This study included 83,732 adult Chinese participants, free of CVD and cancer at baseline. Participants were categorized into 6 groups based on self-report alcohol consumption: 0, 1-25, 26-150, 151-350, 351-750, and > 750 g alcohol/wk. Incident cases of CVD, cancers, and mortality were confirmed by medical records. Hazard ratios (HRs) for the composite risk of these three outcomes, and each individual outcome, were calculated using Cox proportional hazard model. RESULTS: During a median follow-up of 10.0 years, there were 6411 incident cases of CVD, 2947 cancers and 6646 deaths. We observed a J-shaped relation between alcohol intake and risk of CVD, cancer, and mortality, with the lowest risk at 25 g/wk., which is equivalent to ~ 2 servings/wk. Compared to consuming 1-25 g/wk., the adjusted HR for composite outcomes was 1.38 (95% confidence interval (CI):1.29-1.49) for non-drinker, 1.15 (95% CI: 1.04-1.27) for 26-150 g/wk., 1.22 (95% CI: 1.10-1.34) for 151-350 g/wk., 1.33 (95% CI: 1.21-1.46) for 351-750 g/wk., and 1.57 (95% CI: 1.30-1.90) for > 750 g/wk., after adjusting for age, sex, lifestyle, social economic status, and medication use. CONCLUSIONS: Light alcohol consumption at ~ 25 g/wk was associated with lower risk of CVD, cancer, and mortality than none or higher consumption in Chinese adults.

Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial.

INTRODUCTION: The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). METHODS: A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. RESULTS: The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). CONCLUSIONS: This study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.

Growing Healthy Hearts: Gardening Program Feasibility in a Hospital-Based Community Garden.

OBJECTIVE: To assess feasibility in terms of acceptability, demand, and participant willingness to engage in gardening activities during an intervention delivered at a hospital-based community garden for patients at risk for cardiovascular disease (CVD). METHODS: In a pre-post study design, 15 adults with ≥1 CVD risk factor attended 5 education sessions over 12 weeks, tended garden beds, and completed questionnaires related to program acceptability and future gardening intentions. Interviews were used to identify areas for programmatic improvement. RESULTS: Most participants rated the intervention as good or excellent (93%), and 73% indicated that it was likely that they would garden next season. Areas for programmatic improvement included creating opportunities for group discussion, providing online materials, and offering more cooking and gardening content. CONCLUSIONS AND IMPLICATIONS: Gardening as an intervention for adult patients with CVD risk factors is feasible. Assessment of the effect of gardening on health outcomes and dietary intake is warranted.

A Systematic Scoping Review of How Healthcare Organizations Are Facilitating Access to Fruits and Vegetables in Their Patient Populations.

BACKGROUND: There is compelling evidence on the impact of diet as preventative medicine, and with rising health care costs healthcare organizations are attempting to identify interventions to improve patient health outcomes. OBJECTIVES: The purpose of this systematic scoping review was to characterize existing healthcare organization-based interventions to improve access to fruits and vegetables (F&V) for their patient populations. In addition, we aimed to review the impact of identified interventions on dietary intake and health outcomes. METHODS: Titles and abstracts were searched in PubMed® (MEDLINE®), Embase®, CINAHL®, and the Cochrane Library® from 1 January 1990 to 31 December 2019. To be selected for inclusion, original studies must have included a healthcare organization and have had a programmatic focus on increasing access to or providing fresh F&V to patients in an outpatient, naturalistic setting. The Effective Public Health Practice Project tool was used to assess study quality in 6 domains (selection bias, study design, confounders, blinding, data collection methods, and withdrawals and dropouts). RESULTS: A total of 8876 abstracts were screened, yielding 44 manuscripts or abstracts from 27 programs. Six program models were identified: 1) a cash-back rebate program, 2) F&V voucher programs, 3) garden-based programs, 4) subsidized food box programs, 5) home-delivery meal programs, and 6) collaborative food pantry-clinical programs. Only 6 of 27 studies included a control group. The overall quality of the studies was weak due to participant selection bias and incomplete reporting on data collection tools, confounders, and dropouts. Given the heterogeneity of outcomes measured and weak study quality, conclusions regarding dietary and health-related outcomes were limited. CONCLUSIONS: Healthcare-based initiatives to improve patient access to F&V are novel and have promise. However, future studies will need rigorous study designs and validated data collection tools, particularly related to dietary intake, to better determine the effect of these interventions on health-related outcomes.

Opportunities for Growth: Evaluating the Feasibility of a Community Gardening Intervention Pairing Adolescent and Young Adult Cancer Survivors with Experienced Gardeners.

We evaluated the feasibility of a mentored gardening intervention for adolescent and young adult (AYA) cancer survivors in a hospital-based community garden as a way to improve diet and physical activity, using qualitative data to assess the challenges, facilitators, and areas for future programmatic improvement and replication. Over the course of growing season 2018, AYA cancer survivors tended a garden plot in a community garden under the mentorship of an experienced (master) gardener. AYA cancer survivors were successful in planting and harvesting vegetables from the garden in partnership with their mentors. Qualitative results and future directions for the project are discussed.