Using Structured Observations to Evaluate the Effects of a Personalized Music Intervention on Agitated Behaviors and Mood in Nursing Home Residents With Dementia: Results From an Embedded, Pragmatic Randomized Controlled Trial.

OBJECTIVE: The objective of this research was to determine if a personalized music intervention reduced the frequency of agitated behaviors as measured by structured observations of nursing home (NH) residents with dementia. DESIGN: The design was a parallel, cluster-randomized, controlled trial. SETTING: The setting was 54 NH (27 intervention, 27 control) from four geographically-diverse, multifacility NH corporations. PARTICIPANTS: The participants were 976 NH residents (483 intervention, 493 control) with Alzheimer's disease or related dementias (66% with moderate to severe symptoms); average age 80.3 years (SD: 12.3) and 25.1% were Black. INTERVENTION: The intervention was individuals' preferred music delivered via a personalized music device. MEASUREMENT: The measurement tool was the Agitated Behavior Mapping Instrument, which captures the frequency of 13 agitated behaviors and five mood states during 3-minute observations. RESULTS: The results show that no verbally agitated behaviors were reported in a higher proportion of observations among residents in NHs randomized to receive the intervention compared to similar residents in NHs randomized to usual care (marginal interaction effect (MIE): 0.061, 95% CI: 0.028-0.061). Residents in NHs randomized to receive the intervention were also more likely to be observed experiencing pleasure compared to residents in usual care NHs (MIE: 0.038; 95% CI: 0.008-0.073)). There was no significant effect of the intervention on physically agitated behaviors, anger, fear, alertness, or sadness. CONCLUSIONS: The conclusions are that personalized music may be effective at reducing verbally-agitated behaviors. Using structured observations to measure behaviors may avoid biases of staff-reported measures.

Agreement of Antipsychotic Use between Nursing Home Electronic Records and Minimum Data Set.

OBJECTIVES: Nursing home (NH) Minimum Data Set (MDS) have frequently been used to measure medication use in epidemiologic studies, but there is little evidence on the accuracy of MDS-based medication records. We compared antipsychotic use estimated using 2 data sources-MDS and NH electronic medication administration records (eMAR). DESIGN: Cross-sectional comparison. SETTING AND PARTICIPANTS: This analysis was based on MDS and linked eMAR data of 604 NH residents with dementia at 54 NHs in 10 states, participating in a cluster-randomized pragmatic trial (METRIcAL), from June 2019 to February 2020. METHODS: One admission, quarterly, or annual MDS assessment was chosen for each participant. The MDS assessment recorded the number of antipsychotic treatment days during a 7-day window. We then identified antipsychotic administrations during the corresponding window in the eMAR. We used Cohen kappa to assess agreement in the proportion of participants on antipsychotics during the week and used intraclass correlation coefficient (ICC) to assess the agreement of treatment days. We further used the eMAR data as a reference to calculate validity parameters. RESULTS: A total of 29.5% of study participants were identified as antipsychotic users based on the MDS vs 28.3% based on the eMAR data (kappa value: 0.96). MDS-based average treatment duration was estimated to be 2.0, consistent with eMAR-based estimate (1.8 days, ICC: 0.96). The sensitivity was 98.8% (95% CI 95.8%-99.9%), the specificity was 97.9% (95% CI 96.1%-99.1%), the positive predictive value was 94.9% (95% CI 90.8%-97.3%), and the negative predictive value was 99.5% (95% CI 98.2%-99.9%). CONCLUSIONS AND IMPLICATIONS: Agreement between the MDS and eMAR in antipsychotic use is high, suggesting that the MDS is a valid tool to measure antipsychotic use in epidemiologic studies. Further studies with large and diverse populations are warranted to confirm our findings.

Pragmatic Implementation of a Music Intervention in Nursing Homes Before and During COVID-19.

OBJECTIVES: We conducted 2 trials of a music intervention for managing behaviors in nursing home (NH) residents with dementia, before (2019) and during (2021) the pandemic. In this report, we compare adherence fidelity across the trials using the Framework for Implementation Fidelity (FIF). DESIGN: Cross-sectional, descriptive implementation comparison. SETTING AND PARTICIPANTS: Fifty-four NHs randomized to receive the intervention (27 pre-COVID, 27 during COVID) METHODS: We compare the trials on the following FIF criteria: coverage (number of residents receiving the intervention); duration (minutes of music received per exposed day); frequency (percentage of residents with nursing staff use of music in the past week); and details of content (adherence to core components of the intervention). We report NH-level performance in each domain and compare characteristics of NHs in the bottom (low) and top (high) terciles of adherence. RESULTS: Across FIF domains, adherence fidelity was lower during COVID compared with pre-COVID: coverage, residents exposed (COVID: 7.5, SD 5.6; pre-COVID: 12.7, SD 3.6); duration, music minutes per exposed day (COVID: 2.5, SD 5.1; pre-COVID: 27.1, SD 23.9); frequency, percentage of residents with nursing use of intervention in the past week (COVID: 15.0, SD 31.5; pre-COVID 40.4, SD 25.6); and details of content, compliance with core components of the intervention (COVID: 8.3, SD 1.9; pre-COVID 9.6, SD 2.0). In both trials, high-adherence fidelity NHs had better nursing staff ratios, greater percentages of Medicare residents, and lower percentages of Black residents, compared with low-fidelity NHs. CONCLUSIONS AND IMPLICATIONS: Adherence fidelity was worse in the COVID vs pre-COVID trial, despite adaptations between trials intended to reduce staff burden and increase clinical targeting of the intervention. Results may point to the long-term effects of COVID on quality improvement capacity in NHs and/or a lack of available resources in most NHs to implement complex behavioral interventions without direct research support.

Testing an insurance-based monetary incentive program for exercise: RCT design and rationale.

Participation in regular physical activity (PA) has numerous health benefits; however, as few as 10% of U.S. adults meet guidelines when device-based assessments of PA are used. The present paper presents the design and rationale for an RCT examining the efficacy of an exercise incentive program currently offered by at least three major US insurance companies, in which participants must attend a YMCA fitness facility at least 50 times within 6 months to receive an incentive. In a factorial design, incentive amount ($200, $100, $0) is crossed with a comparison of the standard gain-framed incentive program and a loss-framed incentive condition in which participants are told their membership fee is being held and will be returned or forfeited depending on their fitness facility attendance. Participants (N = 330) are randomized to gain-framed $100 incentive (n = 55), gain-framed $200 incentive (n = 55), loss-framed $100 incentive (n = 55), loss-framed $200 incentive (n = 55), or control (n = 110). Each participant is enrolled in the same condition for two consecutive 6-month periods for a total of 12 months per participant. The primary outcome is number of visits to the fitness facility over each 6-month period, verified by objective swipe-card data. Secondary outcomes include total moderate-to-vigorous PA (MVPA) over 7-day periods assessed at 3-month intervals through accelerometers (Actigraph wGT3x-BT) and self-report. Habit formation and anticipated regret are putative mediators and household income is a putative moderator of the incentive-based programs. A payer-perspective, within-trial cost-utility analysis will quantify the incremental costs per (a) quality-adjusted life year gained, (b) YMCA attendance, and (c) change in MVPA.

Examining the Relationship Between Multilevel Resilience Resources and Cardiovascular Disease Incidence, Overall and by Psychosocial Risks, Among Participants in the Jackson Heart Study, the Multi-Ethnic Study of Atherosclerosis, and the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study.

We examined relationships between resilience resources (optimism, social support, and neighborhood social cohesion) and cardiovascular disease (CVD) incidence and assessed potential effect-measure modification by psychosocial risk factors (e.g., stress, depression) among adults without CVD in 3 cohort studies (2000-2018): the Jackson Heart Study, the Multi-Ethnic Study of Atherosclerosis, and the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study. We fitted adjusted Cox models accounting for within-neighborhood clustering while censoring at dropout or non-CVD death. We assessed for effect-measure modification by psychosocial risks. In secondary analyses, we estimated standardized risk ratios using inverse-probability-weighted Aalen-Johansen estimators to account for confounding, dropout, and competing risks (non-CVD deaths) and obtained 95% confidence intervals (CIs) using cluster bootstrapping. For high and medium (versus low) optimism (n = 6,243), adjusted hazard ratios (HRs) for incident CVD were 0.94 (95% CI: 0.78, 1.13) and 0.90 (95% CI: 0.75, 1.07), respectively. Corresponding HRs were 0.88 (95% CI: 0.74, 1.04) and 0.92 (95% CI: 0.79, 1.06) for social support (n = 7,729) and 1.10 (95% CI: 0.94, 1.29) and 0.99 (95% CI: 0.85, 1.16) for social cohesion (n = 7,557), respectively. Some psychosocial risks modified CVD HRs. Secondary analyses yielded similar findings. For optimism and social support, an inverse relationship was frequently most compatible with the data, but a positive relationship was also compatible. For neighborhood social cohesion, positive and null relationships were most compatible. Thus, specific resilience resources may be potential intervention targets, especially among certain subgroups.

Comparing a recommendation for self-paced versus moderate intensity physical activity for midlife adults: Rationale and design.

Current U.S. guidelines recommend that adults obtain 150 min per week of moderate intensity physical activity (PA), 75 min of vigorous intensity PA, or some equivalent combination. However, less than half of U.S. adults reach this goal, with the proportion even smaller among adults with overweight or obesity. Moreover, regular PA declines after age 45-50. Previous research suggests a shift in national guidelines to emphasize PA of a self-selected intensity (i.e., self-paced), instead of prescribed moderate intensity PA, may result in better adherence to PA programs, particularly among midlife adults with overweight or obesity. The present paper presents the protocol for a field-based RCT testing the hypothesis that adherence to PA programs is improved when PA is explicitly recommended to be self-paced rather than prescribed at moderate intensity among midlife (ages 50-64) adults (N = 240) with overweight or obesity. All participants receive a 12-month intervention designed to help them overcome barriers to regular PA and are randomly assigned to either self-paced or prescribed moderate intensity PA. The primary outcome is total volume of PA (minutes by intensity) as measured by accelerometry. Secondary outcomes include self-reported min/week of PA and changes in bodyweight. Additionally, using ecological momentary assessment, we examine putative mediators of treatment effects. We hypothesize self-paced PA will lead to a more positive affective response to PA, more perceived autonomy, and lower perceived exertion during PA, and thus greater increases in PA behavior. Findings will have direct implications for PA intensity recommendations among midlife adults with overweight or obesity.

Social support, psychosocial risks, and cardiovascular health: Using harmonized data from the Jackson Heart Study, Mediators of Atherosclerosis in South Asians Living in America Study, and Multi-Ethnic Study of Atherosclerosis.

Purpose: Social support may have benefits on cardiovascular health (CVH). CVH is evaluated using seven important metrics (Life's Simple 7; LS7) established by the American Heart Association (e.g., smoking, diet). However, evidence from longitudinal studies is limited and inconsistent. The objective of this study is to examine the longitudinal relationship between social support and CVH, and assess whether psychosocial risks (e.g., anger and stress) modify the relationship in a racially/ethnically diverse population. Methods: Participants from three harmonized cohort studies - Jackson Heart Study, Mediators of Atherosclerosis in South Asians Living in America, and Multi-Ethnic Study of Atherosclerosis - were included. Repeated-measures modified Poisson regression models were used to examine the overall relationship between social support (in tertiles) and CVH (LS7 metric), and to assess for effect modification by psychosocial risk. Results: Among 7724 participants, those with high (versus low) social support had an adjusted prevalence ratio (aPR) and 95% confidence interval (CI) for ideal or intermediate (versus poor) CVH of 0.99 (0.96-1.03). For medium (versus low) social support, the aPR (95% CI) was 1.01 (0.98-1.05). There was evidence for modification by employment and anger. Those with medium (versus low) social support had an aPR (95% CI) of 1.04 (0.99-1.10) among unemployed or low anger participants. Corresponding results for employed or high anger participants were 0.99 (0.94-1.03) and 0.97 (0.91-1.03), respectively. Conclusion: Overall, we observed no strong evidence for an association between social support and CVH. However, some psychosocial risks may be modifiers. Prospective studies are needed to assess the social support-CVH relationship by psychosocial risks in racially/ethnically diverse populations.

Examining relationships between perceived neighborhood social cohesion and ideal cardiovascular health and whether psychosocial stressors modify observed relationships among JHS, MESA, and MASALA participants.

BACKGROUND: Psychosocial stressors increase the risks for cardiovascular disease across diverse populations. However, neighborhood level resilience resources may protect against poor cardiovascular health (CVH). This study used data from three CVH cohorts to examine longitudinally the associations of a resilience resource, perceived neighborhood social cohesion (hereafter referred to as neighborhood social cohesion), with the American Heart Association's Life's Simple 7 (LS7), and whether psychosocial stressors modify observed relationships. METHODS: We examined neighborhood social cohesion (measured in tertiles) and LS7 in the Jackson Heart Study, Multi-Ethnic Study of Atherosclerosis, and Mediators of Atherosclerosis in South Asians Living in America study. We used repeated-measures, modified Poisson regression models to estimate the relationship between neighborhood social cohesion and LS7 (primary analysis, n = 6,086) and four biological metrics (body mass index, blood pressure, cholesterol, blood glucose; secondary analysis, n = 7,291). We assessed effect measure modification by each psychosocial stressor (e.g., low educational attainment, discrimination). RESULTS: In primary analyses, adjusted prevalence ratios (aPR) and 95% confidence intervals (CIs) for ideal/intermediate versus poor CVH among high or medium (versus low) neighborhood social cohesion were 1.01 (0.97-1.05) and 1.02 (0.98-1.06), respectively. The psychosocial stressors, low education and discrimination, functioned as effect modifiers. Secondary analyses showed similar findings. Also, in the secondary analyses, there was evidence for effect modification by income. CONCLUSION: We did not find much support for an association between neighborhood social cohesion and LS7, but did find evidence of effect modification. Some of the effect modification results operated in unexpected directions. Future studies should examine neighborhood social cohesion more comprehensively and assess for effect modification by psychosocial stressors.

A multi-component tailored intervention in family childcare homes improves diet quality and sedentary behavior of preschool children compared to an attention control: results from the Healthy Start-Comienzos Sanos cluster randomized trial.

BACKGROUND: Childcare settings are important environments for influencing child eating and physical activity (PA). Family childcare homes (FCCH) care for many children of low-income and diverse racial/ethnic backgrounds who are at greater risk for poor diet quality, low PA, and obesity, but few interventions have targeted this setting. The aim of this study was to assess the efficacy of a multicomponent intervention conducted in FCCH on the diet quality and PA of 2-5 year old children in their care. TRIAL DESIGN: Cluster randomized trial. METHODS: The cluster-randomized trial, Healthy Start/Comienzos Sanos (2015-2019) evaluated an 8-month nutrition and PA intervention that included four components: (1) monthly telephone calls from a support coach using brief motivational interviewing, (2) tailored reports, newsletters and videos, (3) group support meetings, and (4) active play toys. After completing baseline measurement, FCCH were randomized into intervention or comparison groups in matched pairs. Both groups received the same intervention components but on different topics (intervention: nutrition/PA vs. comparison: reading readiness/literacy). Evaluation staff were blinded to group assignment. Child primary outcome measures collected at baseline and 8-months included: 1) Healthy Eating Index (HEI-2015) scores calculated from diet observation, and 2) accelerometer measurement of PA. Process measures were collected from field data and provider surveys. Generalized Estimating Equation Models assessed changes in HEI-2015 scores and PA over time by experimental condition. RESULTS: Ethnically diverse FCCH providers (n = 119) and 2-to-5-year-old children in their care (n = 377) were included in the final analysis. Process evaluation showed high participation in all intervention components except for group meetings. Compared to children in comparison group FCCH, children in intervention FCCH increased total HEI-2015 scores by 7.2 points (p < .001) including improvement in component scores for vegetables (0.84 points, p = .025) and added sugar (0.94 points, p = .025). For PA, compared to children in the comparison group, children in intervention FCCH decreased sedentary time by 5.7% (p = .021). CONCLUSIONS: The multicomponent Healthy Start intervention was effective in improving diet quality and sedentary behavior of children in FCCH, which demonstrates the promise of obesity prevention interventions in this setting. Future research could include enhancing the Healthy Start intervention to strengthen the PA component, considering virtual peer support, and determining how to best translate and disseminate the intervention into FCCH nationally. TRIAL REGISTRATION: National Institutes of Health, NCT02452645 . Registered 5 May 2015.

Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia.

OBJECTIVE: To test the effect of a personalized music intervention on agitated behaviors and medication use among long-stay nursing home residents with dementia. DESIGN: Pragmatic, cluster-randomized controlled trial of a personalized music intervention. Staff in intervention facilities identified residents' early music preferences and offered music at early signs of agitation or when disruptive behaviors typically occur. Usual care in control facilities may include ambient or group music. SETTING AND PARTICIPANTS: The study was conducted between June 2019 and February 2020 at 54 nursing homes (27 intervention and 27 control) in 10 states owned by 4 corporations. METHODS: Four-month outcomes were measured for each resident. The primary outcome was frequency of agitated behaviors using the Cohen-Mansfield Agitation Inventory. Secondary outcomes included frequency of agitated behaviors reported in the Minimum Data Set and the proportion of residents using antipsychotic, antidepressant, or antianxiety medications. RESULTS: The study included 976 residents with dementia [483 treatment and 493 control; mean age = 80.3 years (SD 12.3), 69% female, 25% African American]. CMAI scores were not significantly different (treatment: 50.67, SE 1.94; control: 49.34, SE 1.68) [average marginal effect (AME) 1.33, SE 1.38, 95% CI -1.37 to 4.03]. Minimum Data Set-based behavior scores were also not significantly different (treatment: 0.35, SE 0.13; control: 0.46, SE 0.11) (AME -0.11, SE 0.10, 95% CI -0.30 to 0.08). Fewer residents in intervention facilities used antipsychotics in the past week compared with controls (treatment: 26.2, SE 1.4; control: 29.6, SE 1.3) (AME -3.61, SE 1.85, 95% CI -7.22 to 0.00), but neither this nor other measures of psychotropic drug use were statistically significant. CONCLUSIONS AND IMPLICATIONS: Personalized music was not significantly effective in reducing agitated behaviors or psychotropic drug use among long-stay residents with dementia. Barriers to full implementation included engaging frontline nursing staff and identifying resident's preferred music.

Physical Activity Levels among Preschool-Aged Children in Family Child Care Homes: A Comparison between Hispanic and Non-Hispanic Children Using Accelerometry.

Obesity prevalence among Hispanic children is twice that of non-Hispanic white children; Hispanic children may also engage in less physical activity (PA) compared to non-Hispanic white children. A large number of U.S. preschool-aged children are cared for in Family Child Care Homes (FCCH), yet few studies have examined PA levels and ethnicity differences in PA levels among these children. We examine baseline data from a cluster-randomized trial (Healthy Start/Comienzos Sanos) to improve food and PA environments in FCCHs. Children aged 2-to-5-years (n = 342) wore triaxial accelerometers for two days in FCCHs. Variables examined include percentage of time (%) spent in sedentary, and light, moderate, and vigorous PA. The full dataset (n = 342) indicated sedentary behavior 62% ± 11% of the time and only 10% ± 5% of the time spent in moderate-to-vigorous PA. Among children in the upper-median half of wear-time (n = 176), Hispanic children had significantly greater % sedentary time vs. Non-Hispanic children (66.2% ± 8.3% vs. 62.6% ± 6.9%, p = 0.007), and lower % light PA (25.4% ± 6.3% vs. 27.7% ± 4.9%, p = 0.008) and moderate PA (5.5% ± 2.1% vs. 6.4% ± 2.2%, p = 0.018). Our results highlight that PA levels were lower among our sample compared to previous studies, and that Hispanic children were more sedentary and less active compared to non-Hispanic white children.

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. OBJECTIVE: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. METHODS: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. RESULTS: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. CONCLUSIONS: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23690.

Examining Optimism, Psychosocial Risks, and Cardiovascular Health Using Life's Simple 7 Metrics in the Multi-Ethnic Study of Atherosclerosis and the Jackson Heart Study.

Background: Optimism has been shown to be positively associated with better cardiovascular health (CVH). However, there is a dearth of prospective studies showing the benefits of optimism on CVH, especially in the presence of adversities, i.e., psychosocial risks. This study examines the prospective relationship between optimism and CVH outcomes based on the Life's Simple 7 (LS7) metrics and whether multilevel psychosocial risks modify the aforementioned relationship. Methods: We examined self-reported optimism and CVH using harmonized data from two U.S. cohorts: Multi-Ethnic Study of Atherosclerosis (MESA) and Jackson Heart Study (JHS). Modified Poisson regression models were used to estimate the relationship between optimism and CVH using LS7 among MESA participants (N = 3,520) and to examine the relationship of interest based on four biological LS7 metrics (body mass index, blood pressure, cholesterol, and blood glucose) among JHS and MESA participants (N = 5,541). For all CVH outcomes, we assessed for effect measure modification by psychosocial risk. Results: Among MESA participants, the adjusted risk ratio (aRR) for ideal or intermediate CVH using LS7 comparing participants who reported high or medium optimism to those with the lowest level of optimism was 1.10 [95% Confidence Interval (CI): 1.04-1.16] and 1.05 (95% CI: 0.99-1.11), respectively. Among MESA and JHS participants, the corresponding aRRs for having all ideal or intermediate (vs. no poor) metrics based on the four biological LS7 metrics were 1.05 (0.98-1.12) and 1.04 (0.97-1.11), respectively. The corresponding aRRs for having lower cardiovascular risk (0-1 poor metrics) based on the four biological LS7 metrics were 1.01 (0.98-1.03) and 1.01 (0.98-1.03), respectively. There was some evidence of effect modification by neighborhood deprivation for the LS7 outcome and by chronic stress for the ideal or intermediate (no poor) metrics outcome based on the four biological LS7 metrics. Conclusion: Our findings suggest that greater optimism is positively associated with better CVH based on certain LS7 outcomes among a racially/ethnically diverse study population. This relationship may be effect measure modified by specific psychosocial risks. Optimism shows further promise as a potential area for intervention on CVH. However, additional prospective and intervention studies are needed.

Are self-efficacy measures confounded with motivation? An experimental test.

Standard measures of self-efficacy (SE) may confound perceived capability and motivation because respondents interpret the word "can" as "will". Objective: To test whether priming for the meaning of the word "can" changes self-efficacy ratings. Design: In an experimental test, 134 university students responded to an on-line standardized measure of exercise SE and provided definitions of the words "can" and "will". One month later participants were randomized to complete (a) the same questionnaire (control), (b) the same questionnaire but with presentation of each participant's definition of "can" prior to the SE measure (definition priming), or (c) the same questionnaire but with SE items ("I can exercise…") placed side-by-side with behavioral intention items ("I will exercise…") (side-by-side priming). Results: SE increased relative to controls for side-by-side (b = 12.08, SE = 2.70, p<.01) but not definition priming (ns), with the former even stronger among participants (n = 91) who provided strict (i.e., literal) rather than liberal definitions of "can" (b = 15.38, SE = 3.21, p<.001). Conclusion: Priming of the meaning of the word "can" led to increases in self-efficacy ratings among those who hold a literal meaning of the word "can". This suggests that for many respondents standard assessments of SE may be confounded by motivation.

Improving nutrition and physical activity environments of family child care homes: the rationale, design and study protocol of the 'Healthy Start/Comienzos Sanos' cluster randomized trial.

BACKGROUND: Early childhood is a crucial time to foster healthy eating and physical activity (PA) habits, which are critical for optimal child health, growth and development. Child care facilities are important settings to promote healthy eating and PA and prevent childhood obesity; however, almost all prior intervention studies have focused on child care centers and not family child care homes (FCCH), which care for over 1.6 million U.S. children. METHODS: This paper describes Healthy Start/Comienzos Sanos, a cluster-randomized trial evaluating the efficacy of a multicomponent intervention to improve nutrition and PA environments in English and Spanish-speaking FCCH. Eligible child care providers complete baseline surveys and receive a two-day FCCH observation of the home environment and provider practices. Parent-consented 2-5 year-old children are measured (height, weight, waist circumference), wear accelerometers and have their dietary intake observed during child care using validated protocols. FCCH providers are then randomly assigned to receive an 8-month intervention including written materials tailored to the FCCH providers' need and interest, videos, peer support coaching using brief motivational interviewing, and periodic group meetings focused on either nutrition and PA (Intervention) or reading readiness (Comparison). Intervention materials focus on evidence-based nutrition and physical activity best practices. The initial measures (surveys, two-day observation of the FCCH and provider practices, child diet observation, physical measures, and accelerometer) are assessed again 8 and 12 months after the intervention starts. Primary outcomes are children's diet quality (Healthy Eating Index), time in moderate and vigorous PA and sedentary PA during child care. Secondary outcomes include FCCH provider practices and foods served, and PA environments and practices. Possible mediators (provider attitudes, self-efficacy, barriers and facilitators) are also being explored. Process evaluation measures to assess reach, fidelity and dose, and their relationship with dietary and PA outcomes are included. DISCUSSION: Healthy Start/Comienzos Sanos fills an important gap in the field of childhood obesity prevention by rigorously evaluating an innovative multicomponent intervention to improve the nutrition and physical activity environments of FCCH. TRIAL REGISTRATION: (# NCT02452645 ) ClinicalTrials.gov Trial registered on May 22, 2015.

Nutrition-Related Practices of Family Child Care Providers and Differences by Ethnicity.

BACKGROUND: Child care settings play an important role in shaping children's eating behaviors; yet few studies have included family child care homes (FCCHs). We examined provider-reported nutrition-related practices in FCCHs and observed adherence to nutrition guidelines from the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC), exploring differences by provider ethnicity. METHODS: We assessed baseline data from a cluster-randomized trial, including surveys with FCCH providers and observational data collected at the FCCH. We examined provider-reported nutrition-related practices and if providers met NAP SACC guidelines using observational data. Differences by ethnicity were assessed using chi-square and multivariate log-linear analysis adjusting for education. RESULTS: Providers completed a telephone survey (n = 166, 100% female and 72% Hispanic) and participated in 2 full-day observations (n = 119). Many providers reported engaging in positive nutrition-related practices. Significant differences by ethnicity included the following: Hispanic providers less likely to report feeding practices that were responsive to children's self-regulation, but also less likely to report eating and drinking unhealthy foods/beverages in front of children and having screens on during meals and more likely to report seeking nutrition trainings. Using observational data, only 10 of 26 NAP SACC practices were met by >60% of providers. Few ethnic differences in meeting guidelines were found (7 of 26 practices). CONCLUSIONS: While providers engage in some positive nutrition practices, improvement is needed to ensure that all providers actually meet evidence-based guidelines. Ethnic differences in certain practices underscore the need for culturally relevant trainings. TRIAL REGISTRATION NUMBER: NCT02452645.

Multilevel approaches to increase fruit and vegetable intake in low-income housing communities: final results of the 'Live Well, Viva Bien' cluster-randomized trial.

BACKGROUND: Fruit and vegetable (F&V) intake can reduce risks for chronic disease, but is much lower than recommended amounts in most Western populations, especially for those with low income levels. Rigorous research is needed on practical, cost-effective interventions that address environmental as well as personal determinants of F&V intake. This paper presents the results of a cluster randomized controlled trial evaluating the efficacy of 'Live Well, Viva Bien' (LWVB), a multicomponent intervention that included discount, mobile fresh F&V markets in conjunction with nutrition education. METHODS: Fifteen subsidized housing sites in Providence County, Rhode Island (8 intervention and 7 control sites) were randomized using a random number generator. Of these, nine housed elderly and/or disabled residents and six housed families. A total of 1597 adult housing site residents (treatment n = 837; control n = 760) were enrolled (73% women, 54% Hispanic, 17% black, Mean age 54 years). A year-long multicomponent intervention including mobile F&V markets plus nutrition education (e.g. campaigns, DVDs, newsletters, recipes, and chef demonstrations) was implemented at intervention sites. Physical activity and stress interventions were implemented at control sites. Follow-up occurred at 6 and 12 months. The main outcome measure was F&V consumption measured by National Cancer Institute's 'Eating at America's Table All Day Screener'. RESULTS: From baseline to 12 months, the intervention group increased total F&V intake by 0.44 cups with the control group decreasing intake by 0.08 cups (p < .02). Results also showed an increased frequency of F&V eating behaviors compared to the control group (p < .01). There was a clear dose response effect of the F&V markets with participants who reported attending all or most of the markets increasing F&V intake by 2.1 cups and 0.86 cups, respectively compared with less than half cup increases for lower levels of market attendance (p < .05). Use of the DVDs, recipes and taste-testings was also associated with greater increases in F&V intake; however, use of other educational components was not. CONCLUSIONS: LWVB is the first cluster, randomized controlled trial to demonstrate the efficacy of year-round F&V markets on improving F&V intake for low-income adults, which provides an evidence-base to bolster the mission of mobile produce markets. Further, the results more broadly support investment in environmental changes to alleviate disparities in F&V consumption and diet-related health inequities. TRIAL REGISTRATION NUMBER: Clinicatrials.gov registration number: NCT02669472.

Psychosocial consequences of skin cancer screening.

Screening for melanoma may save lives, but may also cause patient distress. One key reason that preventative visual skin examinations for skin cancer are not currently recommended is the inadequate available evidence to assess potential harm to psychosocial wellbeing. We investigated potential psychological harms and benefits of skin examinations by conducting telephone surveys in 2015 of 187 screened participants; all were ≥35 years old. Participants had their skin examined by practitioners who had completed INFORMED, a validated web-based training for detection of skin cancers, particularly melanoma. Participants underwent the Spielberger State-Trait Anxiety Inventory (STAI), Psychological Consequences of Screening (PCQ), Hospital Anxiety and Depression (HAD) scale, and the 12-Item Short Form Health Survey (SF-12). Analyses were conducted in 2017. Of the entire study sample, 40% were thoroughly screened as determined by patient-reported level of undress and skin areas examined. Participants who were thoroughly screened: did not differ on negative psychosocial measures; scored higher on measures of positive psychosocial wellbeing (PCQ); and were more motivated to conduct monthly self-examinations and seek annual clinician skin examinations, compared to other participants (p < 0.05). Importantly, thoroughly screened patients were more likely to report skin prevention practices (skin self-examinations to identify a concerning lesion, practitioner provided skin exam), recommend skin examinations to peers, and feel satisfied with their skin cancer education than less thoroughly screened individuals (p < 0.01). Our results suggest that visual screening for skin cancer does not worsen patient psychosocial wellbeing and may be associated with improved skin cancer-related practices and attitudes.

A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Good to Go' cluster randomized trial.

BACKGROUND: Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education. METHODS: This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison). Secondary aims include: 1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis of the different intervention arms. DISCUSSION: The GTG study will fill important research gaps in the field by implementing a rigorous cluster randomized trial to evaluate the efficacy of an innovative environmental intervention providing access and availability to F&V at the worksite and whether this access intervention is further enhanced by accompanying educational interventions. GTG will provide an important contribution to public health research and practice. Trial registration number NCT02729675, ClinicalTrials.gov.