The El Valor de Nuestra Salud clustered randomized controlled trial store-based intervention to promote fruit and vegetable purchasing and consumption.

BACKGROUND: Modifying the environment to promote healthy foods is a population-based approach for improving diet. This study evaluated the outcome effectiveness of a food store intervention that used structural and social change strategies to promote fruits and vegetables. It was hypothesized that intervention versus control store customers would improve their consumption of fruits and vegetables at 6 months. TRIAL DESIGN: Clustered randomized controlled trial METHODS: Sixteen pair-matched stores were randomized to an intervention or wait-list control condition. With the research team's support, intervention stores modified the availability, accessibility, and promotion of fruits and vegetables, including augmenting produce displays within the store and building employees' capacity to place and promote fruits and vegetables throughout the store (Phase 1), followed by the delivery of a customer-directed marketing campaign for 6 months (Phase 2). From months 7 to 12, stores were encouraged to maintain strategies on their own (Phase 3). Customer-reported daily fruit and vegetable consumption (cups/day) were collected by blinded research assistants at three time-points (baseline, 6 months and 12 months post-baseline) from 369 participating customers (an average of 23/store). Secondary outcomes included customer-reported fruit and vegetable purchasing and other behaviors. RESULTS: The study retained the 16 stores and most customers at 6 (91%) and 12 (89%) months. Although significant differences were not observed in the overall sample for vegetable consumption, male customers of intervention versus control stores consumed significantly more fruit daily at 6 months [mean (standard deviation) cups at baseline and six months; intervention: 1.6 (1.5) to 1.6 (1.5) vs. control: 1.4 (1.2) to 1.1 (0.8)]. However, this difference was not observed at 12 months, or among females. There was an overall increase in dollars spent at the targeted store in the intervention versus control condition among male versus female customers at 6 months; however, no change was observed in the percent of dollars spent on fruits and vegetables at the targeted store. Frequency of shopping at the targeted store did not modify intervention effects. CONCLUSIONS: Structural and social change interventions can modify customers' behavior in the short-term. Future research should consider methods for achieving longer-term changes, and potential generalizability to other products (e.g., energy-dense sweet and savory products). TRIAL REGISTRATION: NCT01475526.

Distributing and Sourcing Local Produce in Latino-focused Food Stores: A Qualitative Study with Stores and Small Farmers in San Diego County.

A strategy to address challenges in sourcing and maintaining produce in tiendas is to build a new localized food economy. Key informant interviews were conducted with tienda owners and managers and small produce farmers to understand produce distribution and sourcing behaviors, and to identify the potential to connect tiendas with small produce farmers. Interviews were analyzed using an inductive coding approach and were summarized into three themes: people, place, and product. Results provide context for understanding factors that affect access to local produce in Latino communities. Future research should be conducted with produce distributors, and policy-level strategies should be considered.

What influences Latino grocery shopping behavior? Perspectives on the small food store environment from managers and employees in San Diego, California.

To inform the design of a multilevel in-store intervention, this qualitative study utilized in-depth semistructured interviews with 28 managers and 10 employees of small-to-medium-sized Latino food stores (tiendas) in San Diego, California, to identify factors within the tienda that may influence Latino customers' grocery-shopping experiences and behaviors. Qualitative data analysis, guided by grounded theory, was performed using open coding. Results suggest that future interventions should focus on the physical (i.e., built structures) and social (i.e., economic and sociocultural) dimensions of store environments, including areas where the two dimensions interact, to promote the purchase of healthy food among customers.

Primary care-based screening and recruitment for an adolescent depression prevention trial: Contextual considerations during a youth mental health crisis.

Background: Rising rates of adolescent depression in the wake of COVID-19 and a youth mental health crisis highlight the urgent need for accessible mental healthcare and prevention within primary care. Digital mental health interventions (DMHIs) may increase access for underserved populations. However, these interventions are not well studied in adolescents, nor healthcare settings. The purpose of this study was to identify barriers and facilitators to screening and recruitment activities for PATH 2 Purpose (P2P): Primary Care and Community-Based Prevention of Mental Disorders in Adolescents, a multi-site adolescent depression prevention trial comparing two digital prevention programs within four diverse health systems in two U.S. states. Method: This qualitative study is a component of a larger Hybrid Type I trial. We conducted semi-structured key informant interviews with clinical and non-clinical implementers involved with screening and recruitment for the P2P trial. Informed by the Consolidated Framework for Implementation Research (CFIR), interviews were conducted at the midpoint of the trial to identify barriers, facilitators, and needed adaptations, and to gather information on determinants that may affect future implementation. Findings: Respondents perceived the P2P trial as valuable, well aligned with the mission of their health systems. However, several barriers were identified, many of which stemmed from influences outside of the healthcare settings. Universal and site-specific outer setting influences (COVID-19 pandemic, youth mental health crisis, local community conditions) interacted with Inner Setting and Innovation domains to create numerous challenges to the implementation of screening and recruitment. Conclusion: Our findings emphasize the need for ongoing, comprehensive assessment of dynamic inner and outer setting contexts prior to and during implementation of clinical trials, as well as flexibility for adaptation to unique clinical contexts. The CFIR is useful for assessing determinants during times of rapid inner and outer setting change, such as those brought on by the COVID-19 pandemic, youth mental health crisis, and the corresponding exacerbation of resource strain within healthcare settings. Clinical trial registration: PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents https://www.clinicaltrials.gov/study/NCT04290754.

Adolescent mental health problems such as depression, anxiety, and suicidal behavior are prevalent, and have been increasing in the wake of the COVID-19 pandemic. In 2021, the Surgeon General declared a "youth mental health crisis," and the American Academy of Pediatrics issued a joint statement declaring a national youth mental health emergency. Accessible, affordable, evidence-based interventions are needed to prevent the development of depressive symptoms into major depressive disorder. The integration of digital mental health interventions (DMHIs) into primary care may reduce access barriers. Primary care clinical settings are well suited to identify individuals at-risk for developing depression, and facilitate preventive treatment planning. While preventive DMHIs for adolescents exist, more evidence is needed on their effectiveness, and how to best integrate them into healthcare. Our study team interviewed primary care-based staff, administrators, and clinical providers involved with implementing screening and recruitment activities for the P2P trial, a randomized controlled trial comparing the effectiveness of two digital depression prevention programs. Respondents shared experiences with trial recruitment in their settings, including perceived challenges. Our findings suggest that multiple factors influenced recruitment, including influences situated outside of the clinical settings, such as the COVID-19 pandemic and worsening adolescent mental health. These influences interacted with factors affecting recruitment inside of health clinics, such as demands on staff and provider time, and perceived importance of prevention programming versus other initiatives. Identifying these influencing factors during the trial helps to inform considerations for planning future integration of similar programs into primary care settings.

Race/Ethnicity Modifies the Relationship Between Diet Quality at the Home- and Individual-Levels and Weight Status Among African American and Hispanic/Latinx Households With Preschool-Age Children.

Background: Higher obesity prevalence and poorer diet quality disproportionately impacting groups based on income and race/ethnicity may be partially attributed to the home food environment. This study examined home- and individual-level diet quality with weight status among racially/ethnically diverse households. Methods: This cross-sectional study included African American (AA) and Hispanic/Latinx (H/L) households with preschool-age children (n = 97). Home-level diet quality was based on comprehensive home food inventories and individual-level diet quality was based on 24-hour dietary recalls; scores were estimated with the Healthy Eating Index. Child and adult appropriate weight categories based on BMI were estimated with measured heights and weights. Multiple linear regression models (independent variable: weight status, outcome: diet quality scores) with an interaction term for weight status and race/ethnicity and adjusting for potential confounding factors were used to estimate adjusted mean diet quality scores. Postestimation pairwise comparisons of these scores were used to look for within and between group differences by weight status and race/ethnicity. Results: Home-level diet quality scores were significantly higher among H/L households compared to AA counterparts regardless of weight status. AA parents with BMI <30 and AA children with BMI <85th percentile had poorer individual-level diet quality scores compared to AA parents and children of lower weight status and all H/L parents and children. Conclusions: These findings offer evidence that race/ethnicity modifies the relationship between diet quality and weight among AA and H/L households. Future research needs to examine the distinctive ways race/ethnicity shapes the relationship between weight and diet quality in these households.

Comparing the gut microbiome of obese, African American, older adults with and without mild cognitive impairment.

Those with mild cognitive impairment (MCI), a precursor to dementia, have a gut microbiome distinct from healthy individuals, but this has only been shown in healthy individuals, not in those exhibiting several risk factors for dementia. Using amplicon 16S rRNA gene sequencing in a case-control study of 60 older (ages 55-76), obese, predominately female, African American adults, those with MCI (cases) had different gut microbiota profiles than controls. While microbial community diversity was similar between cases and controls, the abundances of specific microbial taxa weren't, such as Parabacteroides distasonis (lower in cases) and Dialister invisus (higher in cases). These differences disappeared after adjusting for markers of oxidative stress and systemic inflammation. Cognitive scores were positively correlated with levels of Akkermansia muciniphila, a bacterium associated with reduced inflammation. Our study shows that gut microbial composition may be associated with inflammation, oxidative stress, and MCI in those at high risk for dementia.

Exploring the Effects of a Mediterranean Diet and Weight Loss on the Gut Microbiome and Cognitive Performance in Older, African American Obese Adults: A Post Hoc Analysis.

African American adults have a higher prevalence of Alzheimer's dementia (AD) than non-Hispanic Whites. The impact of a Mediterranean Diet (Med Diet) and intentional weight loss (IWL) on the gut microbiome may alter AD risk. A post hoc analysis of the Building Research in Diet and Cognition (BRIDGE) trial was performed to determine whether participation in an 8-month Med Diet lifestyle intervention with (n = 35) or without IWL (n = 31) was associated with changes in gut microbiota structure, abundance, and function and whether these changes were related to changes in cognitive performance. The results showed that family and genus alpha diversity increased significantly in both groups combined (p = 0.0075 and p = 0.024, respectively). However, there were no other significant microbially related within- or between-group changes over time. Also, an increase in Med Diet adherence was significantly associated with a decrease in alpha diversity at the phylum level only (p = 0.049). Increasing alpha diversity was associated with decreasing cognitive performance, but this association was attenuated after controlling for Med Diet adherence. In sum, an 8-month Med Diet lifestyle intervention with or without IWL did not appreciably alter the gut microbiome.

PATH 2 Purpose: Design of a comparative effectiveness study of prevention programs for adolescents at-risk for depression in the primary care setting.

The majority of mental, emotional, and behavioral (MEB) disorders have an initial onset before age 24, with 20% annual incidence, and with major depressive disorder (MDD) being the most common MEB. Health systems may be able to reduce costs by transitioning from the current treatment-focused model for MDD to a prevention model. However, evidence is needed for (1) the comparative effectiveness of a "scalable intervention" and (2) an implementation model for such a scalable intervention in the primary care setting. This paper describes a comparative effectiveness trial evaluating the efficacy of two evidence-based cognitive-behavioral prevention (CBP) programs: Teens Achieving Mastery over Stress (TEAMS), the "gold standard," group therapy model, and Competent Adulthood Transition with Cognitive Behavioral, Humanistic and Interpersonal Training (CATCH-IT), a scalable, self-directed, technology-based model. Eligible adolescents, age 13-19, are offered one of these two depression prevention programs across five health systems (30 clinics) in urban and suburban Chicago, IL, rural Western IL, and Louisville, KY. We are comprehensively evaluating patient-centered outcomes and stakeholder-valued moderators of effect versus baseline at two, six, 12, and 18-month assessment points. Using a hybrid clinical trial design that simultaneously examines the implementation process, the study is also assessing adolescents', parents', and providers' experiences (e.g., efficacy, time commitment, cultural acceptability) within each intervention approach.

Black American and Latinx Parent/Caregiver Participation in Digital Health Obesity Interventions for Children: A Systematic Review.

Parents/caregivers are consistently described as integral targets given their influential role in supporting and managing behaviors such as diet and physical activity. Identifying effective obesity prevention interventions to enhance and sustain parent participation is needed. Digital obesity prevention interventions are a promising strategy to improve parent/caregiver participation. Digital health interventions demonstrate acceptable participation and retention among parents/caregivers. However, our understanding of digital obesity prevention interventions targeting Black American and Latinx parents/caregivers is limited. This systematic review aims to identify Black American and Latinx parents'/caregivers' level of participation in digital obesity prevention and treatment interventions and determine the relationship between parent/caregiver participation and behavioral and weight status outcomes. This review adheres to PRISMA guidelines and is registered in PROSPERO. Eligibility criteria include: intervention delivered by digital technology, targeted Black American and Latinx parents/caregivers of young children (2-12 years), reported parent/caregiver participation outcomes, targeted diet or physical activity behaviors, and randomized controlled trial study design. Searches were conducted in September 2020 in ERIC, PsychInfo, PubMed, and Web of Science. Initial searches returned 499 results. Four reviewers screened records against eligibility criteria and 12 studies met inclusion criteria. Across all studies, parent/caregiver participation ranged from low to high. Only half of the included studies reported significant improvements in behavioral or weight status outcomes for parents/caregivers and/or children. Of these studies, three reported high parental/caregiver participation rates, and three reported high satisfaction rates. These findings suggest that participation and satisfaction may impact behavior change and weight status. The small number of studies indicates that additional research is needed to determine whether engagement or other factors predict responsiveness to the digital health intervention. Our results lay the groundwork for developing and testing future digital health interventions with the explicit goal of parental/caregiver participation and considers the need to expand our digital health intervention research methodologies to address obesity inequities among diverse families better.

Support policies that foster a healthy food environment and incentivize healthy food purchases to mitigate cancer inequities.

The COVID-19 pandemic has highlighted the inequitable access to resources, leading to a disproportionate burden of disease in vulnerable communities in the USA. However, these inequities in health outcomes are not limited to COVID-19. Approximately 18% of cancers are related to dietary behaviors and excess body weight. Underserved communities, such as minority racial/ethnic groups living in neighborhoods of low socioeconomic status, experience barriers to healthy eating including lack of access to high-quality healthy foods and higher availability of unhealthy foods and beverages in local retail food outlets. Strikingly, these same populations are more likely to die from cancers related to dietary intake and obesity like colorectal, liver, and pancreatic cancers. To reduce cancer inequities, policy makers can act by supporting programs that incentivize healthy food purchases and improve the local food environment in underserved communities.

Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial.

BACKGROUND: The COVID-19 pandemic has altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them. DESIGN: This brief report describes the experience of adapting the Building Research in Diet and Cognition (BRIDGE) study, a randomized clinical trial examining the effects of the Mediterranean diet, with and without weight loss, on cognitive functioning in 185 older obese African American adults during the COVID-19 pandemic. MEASUREMENT: The University of Illinois at Chicago (UIC) developed an expedited amendment process for research shifting to remote data collection. We conducted the study in three consecutive groups. For group 3, 14-month data collection period, we adapted our protocol to allow data collection via telephone and e-mail. We were unable to collect certain measures that required face-to-face contact. RESULTS: For measures that could be collected remotely, 14-month retention was similar for group 3 compared to groups 1 and 2: data were collected for 86.9% of group 3 (remote) and 87.9% of groups 1 and 2 (face to face), p = .84. CONCLUSIONS: In order to preserve the integrity of our clinical trial and ensure the safety of our participants and staff during the COVID-19 pandemic, we had to carefully and efficiently adapt our data collection procedures. The procedures put in place allowed us to collect our primary outcomes and the majority of our secondary outcomes and will enable us to examine the role of dietary intake, with and without weight loss, on cognitive functioning in a vulnerable and high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov NCT3129048. Registration Date: 4/17/2017.

Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE).

Background . The COVID-19 pandemic has significantly altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them. Design . This brief report describes the experience of adapting the Building Research in Diet and Cognition (BRIDGE) study, a randomized clinical trial examining the effects of the Mediterranean Diet, with and without weight loss, on cognitive functioning in 185 older obese African American adults during the COVID-19 pandemic. Measurement . The University of Illinois at Chicago (UIC) developed an expedited amendment process for research shifting to remote data collection. For the Cohort 3, 14-month data collection period, we adapted our protocol to allow data collection via telephone and e-mail. We were unable to collect certain measures that required face-to face contact. Results . For measures that could be collected remotely, 14-month retention was similar for Cohort 3 and earlier cohorts: data were collected for 86.9% of cohort 3 (remote) and 87.9% of cohorts 1 and2 (face to face), p = .84. Conclusions . In order to preserve the integrity of our clinical trial and ensure the safety of our participants and staff during the COVID-19 pandemic, we had to carefully and efficiently adapt our data collection procedures. The procedures put in place allowed us to collect our primary outcomes and the majority of our secondary outcomes and will enable us to examine the role of dietary intake, with and without weight loss, on cognitive functioning in a vulnerable and high-risk population. ClinicalTrials.gov NCT03129048.

Building research in diet and cognition (BRIDGE): Baseline characteristics of older obese African American adults in a randomized controlled trial to examine the effect of the Mediterranean diet with and without weight loss on cognitive functioning.

In the United States, >5.4 million people age 65 and older are affected by cognitive impairment and dementia, including Alzheimer's disease. African Americans are more likely than non-Hispanic whites to suffer from these disorders. Obesity is linked to accelerated age-related cognitive decline, and weight loss through caloric restriction is a potential strategy to prevent this cognitive impairment. Adherence to a healthful dietary pattern, such as the Mediterranean Diet (MedDiet), has also shown positive effects on reducing risk for dementia. African Americans are disproportionately affected by obesity and have less healthful diets than non-Hispanic whites. We present baseline characteristics from a three-arm randomized controlled trial that randomized 185 obese (BMI ≥ 30 kg/m2 and ≤ 50 kg/m2) healthy older adults (55-85 years of age) to: 1) Typical Diet Control (TDC); 2) MedDiet alone (MedDiet-A) intervention; or 3) MedDiet caloric restricted intervention to promote weight loss (MedDiet-WL). The majority of the sample was African American (91.4%) and female (85.9%). The two active interventions (MedDiet-A and MedDiet-WL) met once weekly for 8 months, and the TDC received weekly general health newsletters. Baseline data were collected between January 2017 and July 2019 in Chicago, IL. In our sample, closer adherence to a MedDiet pattern was associated with higher attention and information processing (AIP) and higher executive functioning (EF). Consistent with the literature, we saw that older participants performed more poorly on the cognitive assessments than younger participants, and women outperformed men across verbally mediated tasks, especially ones related to learning and memory.

A systematic review of the implementation of obesity prevention interventions in early childcare and education settings using the RE-AIM framework.

Previous systematic reviews have examined the efficacy of obesity prevention interventions within early childcare/education settings. Often lacking in these reviews is reporting on external validity, which continues to be underemphasized compared to internal validity. More attention to external validity would help better translate evidence-based interventions to real-world settings. This systematic review aimed to determine the availability of data on both internal and external validity across dimensions of the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework in studies reporting on obesity prevention interventions in early childcare/education settings. Inclusion criteria included: randomized controlled trials, early childcare/education setting, targeted children 2-6 years old, addressed both diet and physical activity, collected measures of weight status and diet and/or physical activity, and published within the last 10 years. Searches were conducted in ERIC, PsychInfo, and PubMed; 23 studies met inclusion criteria. A validated RE-AIM abstraction tool was used to code studies. Most commonly reported dimensions were Reach (62.3%), Implementation (53.5%), and Efficacy/Effectiveness (48.7%). Adoption (21.7%) and Maintenance (11.6%) were less often reported. All studies reported on primary outcomes, but few reported on RE-AIM indicators of characteristics of participation and adoption, quality of life, methods used to identify staff, staff inclusion/exclusion criteria and adoption rates, implementation fidelity, measures of cost to start-up and deliver the intervention, and indicators of maintenance. This systematic review underscores the need for more focus on external validity to inform replication, dissemination, and implementation so that evidence-based early childcare/education obesity interventions can be generalized to real-world settings.

Fruit and Vegetable Intake of US Hispanics by Food Store Type: Findings from NHANES.

This study examined fruit and vegetable intake by food store type shopped among US Hispanics. Using National Health and Nutrition Examination Survey 2011-2012 data, T test and chi-square tests examined differences between Hispanic consumers by food store type. Negative binomial regression analyses estimated associations between fruit and vegetable intake and food store type. Hispanics who only purchased fruits and vegetables from convenience stores were younger and more likely US born. They reported lower intakes of fruit and vegetables than individuals who purchased these foods from supermarket/grocery stores. Those who primarily purchased fruits and vegetables from supermarkets/grocery stores consumed 0.92 (p < .001) greater fruit cup equivalents and 0.26 (p = .001) greater vegetable cup equivalents than those who only purchased from convenience stores. Research on the influence of shopping in multiple food store types is needed to develop targeted in-store intervention strategies to encourage healthier food purchases. Results provide support for policy-level research such as minimum stocking requirements for healthy foods in convenience stores.

Evaluation of Store Environment Changes of an In-Store Intervention to Promote Fruits and Vegetables in Latino/Hispanic-Focused Food Stores.

Implementing interventions that manipulate food store environments are one potential strategy for improving dietary behaviors. The present study evaluated intervention effects, from the El Valor de Nuestra Salud (The Value of Our Health) study, on in-store environmental changes within Latino/Hispanic-focused food stores (tiendas). Sixteen tiendas were randomly assigned to either: a six-month structural and social food store intervention or a wait-list control condition. Store-level environmental measures of product availability, placement, and promotion were assessed monthly from baseline through six-months post-baseline using store audits. Linear mixed effects models tested for condition-by-time interactions in store-level environmental measures. Results demonstrated that the intervention was successful at increasing the total number of fruit and vegetable (FV) promotions (p < 0.001) and the number of FV promotions outside the produce department (p < 0.001) among tiendas in the intervention versus control condition. No changes in product availability or placement were observed. Results suggests changing the marketing mix element of promotions within small stores is measurable and feasible in an in-store intervention. Difficulties in capturing changes in product availability and placement may be due to intervention implementation methods chosen by tiendas. It is important to build upon the lessons learned from these types of interventions to disseminate evidence-based in-store interventions.

Examination of the Relationship between In-Store Environmental Factors and Fruit and Vegetable Purchasing among Hispanics.

Retail food environments have received attention for their influence on dietary behaviors and for their nutrition intervention potential. To improve diet-related behaviors, such as fruit and vegetable (FV) purchasing, it is important to examine its relationship with in-store environmental characteristics. This study used baseline data from the "El Valor de Nuestra Salud" study to examine how in-store environmental characteristics, such as product availability, placement and promotion, were associated with FV purchasing among Hispanic customers in San Diego County. Mixed linear regression models indicated that greater availability of fresh FVs was associated with a $0.36 increase in FV purchasing (p = 0.01). Placement variables, specifically each additional square foot of display space dedicated to FVs (p = 0.01) and each additional fresh FV display (p = 0.01), were associated with a $0.02 increase and $0.29 decrease, respectively, in FV purchasing. Introducing FV promotions in the final model was not related to FV purchasing. Exploratory analyses indicated that men reported spending $3.69 fewer dollars on FVs compared to women, controlling for covariates (p = 0.02). These results can help inform interventions targeting in-store environmental characteristics to encourage FV purchasing among Hispanics.

A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial.

INTRODUCTION: Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small- to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. METHODS: Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. RESULTS: Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. CONCLUSIONS: Determining whether a tienda-based intervention can improve customers' FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments.