Humberto Parada

Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial

IMPORTANCE Pictorial warnings on cigarette packs draw attention and increase quit intentions, but their effect on smoking behavior remains uncertain. OBJECTIVE To assess the effect of adding pictorial warnings to the front and back of cigarette packs. DESIGN, SETTING, AND PARTICIPANTS This 4-week between-participant randomized clinical trial was carried out in California and North Carolina. We recruited a convenience sample of adult cigarette smokers from the general population beginning September 2014 through August 2015. Of 2149 smokers who enrolled, 88% completed the trial. No participants withdrew owing to adverse events. INTERVENTIONS We randomly assigned participants to receive on their cigarette packs for 4 weeks either text-only warnings (one of the Surgeon Generals warnings currently in use in the United States on the side of the cigarette packs) or pictorial warnings (one of the Family Smoking Prevention and Tobacco Control Acts required text warnings and pictures that showed harms of smoking on the top half of the front and back of the cigarette packs). MAIN OUTCOMES AND MEASURES The primary trial outcome was attempting to quit smoking during the study. We hypothesized that smokers randomized to receive pictorial warnings would be more likely to report a quit attempt during the study than smokers randomized to receive a text-only Surgeon Generals warning. RESULTS Of the 2149 participants who began the trial (1039 men, 1060 women, and 34 transgender people; mean [SD] age, 39.7 [13.4] years for text-only warning, 39.8 [13.7] for pictorial warnings), 1901 completed it. In intent-to-treat analyses (n = 2149), smokers whose packs had pictorial warnings were more likely than those whose packs had text-only warnings to attempt to quit smoking during the 4-week trial (40% vs 34%; odds ratio [OR], 1.29; 95% CI, 1.09-1.54). The findings did not differ across any demographic groups. Having quit smoking for at least the 7 days prior to the end of the trial was more common among smokers who received pictorial than those who received text-only warnings (5.7% vs 3.8%; OR, 1.53; 95% CI, 1.02-2.29). Pictorial warnings also increased forgoing a cigarette, intentions to quit smoking, negative emotional reactions, thinking about the harms of smoking, and conversations about quitting. CONCLUSIONS AND RELEVANCE Pictorial warnings effectively increased intentions to quit, forgoing cigarettes, quit attempts, and successfully quitting smoking over 4 weeks. Our trial findings suggest that implementing pictorial warnings on cigarette packs in the United States would discourage smoking. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02247908.

Peer Support in Health Care and Prevention: Cultural, Organizational, and Dissemination Issues

As reviewed in the article by Perry and colleagues (2014) in this volume, ample evidence has documented the contributions of peer support (PS) to health, health care, and prevention. Building on that foundation, this article discusses characteristics, contexts, and dissemination of PS, including (a) fundamental aspects of the social support that is often central to it; (b) cultural influences and ways PS can be tailored to specific groups; (c) key features of PS and the importance of ongoing support and backup of peer supporters and other factors related to its success; (d) directions in which PS can be expanded beyond prevention and chronic disease management, such as in mental health or interventions to prevent rehospitalization; (e) other opportunities through the US Affordable Care Act, such as through patient-centered medical homes and chronic health homes; and (f) organizational and policy issues that will govern its dissemination. All these demonstrate the extent to which PS needs to reflect its contexts--intended audience, health problems, organizational and cultural settings--and, thus, the importance of dissemination policies that lead to flexible response to contexts rather than constraint by overly prescriptive guidelines.

Correlates of medication nonadherence among Latinos with type 2 diabetes.

Purpose The purpose of this study is to assess factors related to diabetes medication nonadherence in a sample of predominantly Spanish-speaking Mexican-origin adults residing along the US-Mexico border. Methods As part of a randomized controlled trial, 302 patients randomly sampled from a clinic roster completed a baseline interview. Medication nonadherence was assessed with the Morisky Medication Adherence Scale. Consistent with the framework proposed by Venturini et al, four factors were examined: patient-related attributes, drug regimen characteristics and complexity, health status, and patient-provider interaction characteristics. Results Sixty percent of the patients were classified as nonadherent. Men, those who engaged in diabetes control behaviors less frequently, and individuals with depression were more likely to be classified as nonadherent. Among those who were Spanish-dominant, education and self-rated health also were significantly and negatively related to medication adherence; patients with a high school education or greater and those who more positively rated their health were more likely to be classified as nonadherent compared to those with less than a high school education and those who rated their health as poor. Conclusions Results reflect potentially higher medication nonadherence rates for Latinos with type 2 diabetes living in rural communities along the US-Mexico border. Additionally, this study supports the need to address strategies to support medication adherence, including addressing depression, for diabetes control. Strategies to promote adherence among Latino men are sorely needed, as are strategies to address forgetfulness and carelessness regarding diabetes medicine taking.

Puentes hacia una mejor vida (Bridges to a Better Life): Outcome of a Diabetes Control Peer Support Intervention

PURPOSE Peer support can promote diabetes control, yet research on feasible and effective peer support models is lacking. This randomized controlled trial tested a volunteer-based model of peer support for diabetes control. METHODS Thirty-four volunteer peer leaders were recruited and trained to provide support to 5 to 8 patients each through telephone contact, in-person, individual, and group support. Planned dose was 8 contacts, preferably in the first 6 months. Patients with uncontrolled diabetes were randomly sampled from the medical records of 3 community clinics. After a baseline interview and medical records review to obtain baseline values for the primary outcome, HbA1c, 336 patient participants were randomly assigned to a 12-month peer support intervention or usual care. The assessment protocol was repeated at 6 and 12 months after baseline. RESULTS Thirty peer leaders delivered an average of 4 contacts each per assigned participant (range 1–24). Despite the lack of intervention fidelity, the intervention was effective at reducing glycated hemoglobin (HbA1c) among intervention as compared with usual care participants (P=0.05). Similar trends were observed in frequency of meeting fruit and vegetable guidelines (P =0.09), a secondary outcome. Counterintuitively, usual care participants reported checking their feet more days out of 7 than intervention participants (P =0.03). CONCLUSIONS Given the modest changes we observed, combined with other evidence for peer support to promote diabetes control, additional research is needed on how to modify the system of care to increase the level of peer support delivered by volunteers.

Family Support Is Associated With Behavioral Strategies for Healthy Eating Among Latinas

Background. Healthy eating is important for obesity control. Dietary interventions target the adoption of behavioral strategies to increase fiber and decrease fat consumption. However, little is known about the contributions of psychosocial factors to the use of these strategies. Purpose. This study examined psychosocial correlates of behavioral strategies for healthy eating among Latinas. Method. Participants included 361 Latino mothers living along the U.S.–Mexico border in California. Data included measures of sociodemographics, acculturation, and psychosocial determinants of healthy eating. A 30-item dietary behavioral strategies scale assessed strategies to increase fiber and decrease fat consumption. Results. Family interactions regarding dietary habits (β = .224, p < .001) and financial status (β = .148, p = .029) were associated with the use of strategies to decrease fat consumption. Positive family interactions regarding dietary habits (β = .226, p < .001), fewer barriers to obtaining fruits and vegetables (β = −.207, p < .001), and more family support for vegetable purchasing (β = .070, p = .047) were associated with use of strategies to increase fiber consumption. Conclusions. Future interventions would benefit from improving family systems associated with healthy eating.

Negative affect, message reactance and perceived risk: how do pictorial cigarette pack warnings change quit intentions?

Objective Pictorial warnings on cigarette packs increase motivation to quit smoking. We sought to examine the potential mediating role of negative affect, message reactance (ie, an oppositional reaction to a message) and perceived risk in shaping quit intentions. Methods In 2014 and 2015, we randomly assigned 2149 adult US smokers to receive either pictorial warnings or text-only warnings applied to their cigarette packs for 4 weeks. Analyses used structural equation modelling with bootstrapped SEs to test our theorised mediational model. Findings Pictorial warnings increased negative affect, message reactance and quit intentions (all P<0.001), but not perceived risk (ie, perceived likelihood and severity of harms of smoking). Negative affect mediated the impact of pictorial warnings on quit intentions (mediated effect=0.16, P<0.001). Message reactance weakened the impact of pictorial warnings on quit intentions, although the effect was small (mediated effect=−0.04, P<0.001). Although pictorial warnings did not directly influence perceived risk, the model showed additional small mediation effects on quit intentions through negative affect and its positive association with perceived risk (mediated effect=0.02, P<0.001), as well as reactance and its negative association with perceived risk (mediated effect=−0.01, P<0.001). Conclusions Pictorial cigarette pack warnings increased quit intentions by increasing negative affect. Message reactance partially attenuated this increase in intentions. The opposing associations of negative affect and reactance on perceived risk may explain why pictorial warnings did not lead to observable changes in perceived risk.

Polychlorinated biphenyls and their association with survival following breast cancer

BACKGROUND Polychlorinated biphenyls (PCBs) are hypothesised to influence breast carcinogenesis due to their persistence and potential to induce oestrogenic and anti-oestrogenic effects. Whether PCBs influence survival following breast cancer is unknown. METHODS A population-based cohort of women diagnosed with first primary invasive or in situ breast cancer in 1996-1997 and with blood-measured PCBs (n=627) collected shortly after diagnosis was followed for vital status through 2011. After 5 and 15 years, we identified 54 and 187 deaths, respectively, of which 36 and 74 were breast cancer related. Using Cox regression, we estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for mortality for baseline PCB concentrations, individually and as oestrogenic (ΣGroup 1B: PCB101, PCB174, PCB177, PCB187, and PCB199), anti-oestrogenic (ΣGroup 2A: PCB66, PCB74, PCB105, and PCB118; ΣGroup 2B: PCB138 and PCB170), and cytochrome P450 enzyme-inducing (ΣGroup 3: PCB99, PCB153, PCB180, PCB183, and PCB203) groups. RESULTS The highest PCB174 tertile was associated with an increase in all-cause (HR=2.22, 95% CI: 1.14-4.30) and breast cancer-specific (HR=3.15, 95% CI: 1.23-8.09) mortalities within 5 years of diagnosis and remained associated with breast cancer-specific mortality (HR=1.88, 95% CI: 1.05-3.36) at 15 years. At 5 years, the highest tertile of PCB177 was positively associated with all-cause mortality (HR=2.12, 95% CI: 1.05-4.30). At 15 years, the highest tertiles of ΣGroup 2A congeners and PCB118 were inversely associated with all-cause mortality (HR=0.60, 95% CI: 0.39-0.83; HR=0.63, 95% CI: 0.43-0.92, respectively). CONCLUSIONS In this first US study of PCBs and breast cancer survival, PCBs were associated with mortality in biologically plausible directions. The investigation of other, structurally similar, chemicals may be warranted.

Organochlorine insecticides DDT and chlordane in relation to survival following breast cancer

Organochlorine insecticides have been studied extensively in relation to breast cancer incidence, and results from two meta‐analyses have been null for late‐life residues, possibly due to measurement error. Whether these compounds influence survival remains to be fully explored. We examined associations between organochlorine insecticides [p,p′‐DDT (dichlorodiphenyltrichloroethane), its primary metabolite, p,p′‐DDE, and chlordane] assessed shortly after diagnosis and survival among women with breast cancer. A population‐based sample of women diagnosed with a first primary invasive or in situ breast cancer in 1996–1997 and with available organochlorine blood measures (n = 633) were followed for vital status through 2011. After follow‐up of 5 and 15 years, we identified 55 and 189 deaths, of which 36 and 74, respectively, were breast cancer‐related. Using Cox regression models, we estimated the multivariable‐adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for lipid‐adjusted organochlorine concentrations with all‐cause and breast cancer‐specific mortality. At 5 years after diagnosis, the highest tertile of DDT concentration was associated with all‐cause (HR = 2.19; 95% CI: 1.02, 4.67) and breast cancer‐specific (HR = 2.72; 95% CI: 1.04, 7.13) mortality. At 15 years, middle tertile concentrations of DDT (HR = 1.42; 95% CI 0.99, 2.06) and chlordane (HR = 1.42; 95% CI: 0.94, 2.12) were modestly associated with all‐cause and breast cancer‐specific mortality. Third tertile DDE concentrations were inversely associated with 15‐year all‐cause mortality (HR = 0.66; 95% CI: 0.44, 0.99). This is the first population‐based study in the United States to show that DDT may adversely impact survival following breast cancer diagnosis. Further studies are warranted given the high breast cancer burden and the ubiquity of these chemicals.

An Ecological Perspective on Diabetes Self-care Support, Self-management Behaviors, and Hemoglobin A1C Among Latinos:

Purpose The purpose of this study was to examine the role of self, interpersonal (ie, family/friend), and organizational (ie, health care) support in performing diabetes-related self-management behaviors and hemoglobin A1C (A1C) levels among rural Latinos with type 2 diabetes. Methods Cross-sectional data from baseline interviews and medical records were used from a randomized controlled trial conducted in rural Southern California involving a clinic sample of Latinos with type 2 diabetes (N = 317). Self-management behaviors included fruit and vegetable intake, fat intake, physical activity, glucose monitoring, daily examination of feet, and medication adherence. Multivariate linear and logistic regression models were used to assess the relationships of sources of support with self-management behaviors and A1C. Results Higher levels of self-support were significantly associated with eating fruits and vegetables most days/week, eating high-fat foods few days/week, engaging in physical activity most days/week, daily feet examinations, and self-reported medication adherence. Self-support was also related to A1C. Family/friend support was significantly associated with eating fruits and vegetables and engaging in physical activity most days/week. Health care support was significantly associated with consuming fats most days/week. Conclusions Health care practitioners and future interventions should focus on improving individuals’ diabetes management behaviors, with the ultimate goal of promoting glycemic control. Eliciting family/friend support should be encouraged to promote fruit and vegetable consumption and physical activity.

A Process Evaluation of an Efficacious Family-Based Intervention to Promote Healthy Eating The Entre Familia: Reflejos de Salud Study

Entre Familia: Reflejos de Salud was a successful family-based randomized controlled trial designed to improve dietary behaviors and intake among U.S. Latino families, specifically fruit and vegetable intake. The novel intervention design merged a community health worker (promotora) model with an entertainment-education component. This process evaluation examined intervention implementation and assessed relationships between implementation factors and dietary change. Participants included 180 mothers randomized to an intervention condition. Process evaluation measures were obtained from participant interviews and promotora notes and included fidelity, dose delivered (i.e., minutes of promotora in-person contact with families, number of promotora home visits), and dose received (i.e., participant use of and satisfaction with intervention materials). Outcome variables included changes in vegetable intake and the use of behavioral strategies to increase dietary fiber and decrease dietary fat intake. Participant satisfaction was high, and fidelity was achieved; 87.5% of families received the planned number of promotora home visits. In the multivariable model, satisfaction with intervention materials predicted more frequent use of strategies to increase dietary fiber (p ≤ .01). Trends suggested that keeping families in the prescribed intervention timeline and obtaining support from other social network members through sharing of program materials may improve changes. Study findings elucidate the relationship between specific intervention processes and dietary changes.