[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07490652":3,"trial-entities:NCT07490652":112,"trial-summary:NCT07490652":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":62,"locations":65,"central_contacts":105,"overall_officials":108,"references":110,"see_also_links":111},"NCT07490652","STUDY00021082","Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention","RECRUITING","2029-05","2026-08","2026-08-12","2026-04-17","University of Washington","OTHER",true,"The goal of this clinical trial is to adapt and implement The Value of Our Health (Our Value), a program to promote eating fruit and vegetables, for people living in rural areas. The program will be offered in small, independent grocery stores and delivered by community health workers. The main question this study will answer is: Do customers who shop at stores receiving Our Value eat more fruits and vegetables than customers of other stores?","In this trial, researchers seek to augment the benefits of Our Value by adding community health workers (CHWs) to deliver the intervention and adapting and testing its effectiveness in rural communities in central Washington State. People in these rural areas experience social and structural barriers to the consumption of fruits and vegetables (FV), such as limited access to fresh, varied, affordable FV and long commutes to food retailers. Yet, these communities also have a strong identity and supportive community networks; thus, our partners endorsed training CHWs to deliver the intervention. CHWs are known for effective delivery of health promotion interventions to reduce health disparities; they are recognized as trusted and respected leaders in rural communities.\n\nTo test the implementation and effectiveness of the adapted intervention, researchers use a hybrid type I cluster-randomized controlled trial (RCT) study design and apply the Retail Food Environment and Customer Interactions Model and RE-AIM framework. The study will occur in three rural counties in Washington State.\n\nTo evaluate the effects of the intervention on customers, the research team will conduct customer surveys to measure fruit and vegetable purchasing and eating.\n\nThe proposed study will contribute to reducing access to FV-related chronic disease health disparities in rural areas through behavioral-, store-, and community-level intervention. The study will shed light on the nuances, resources, and challenges of conducting health promotion and disease prevention research in rural areas. The results will provide new tools and evidence for researchers and practitioners to translate and implement evidence-based interventions in rural communities, and community-level health promotion interventions to reduce health disparities.",[18,19,20,21],"Hispanic Americans","Chronic Disease Prevention","Cancer Prevention","Fruit and Vegetable Consumption",[18,23,21,20,19,24],"Rural Population","Latino Health","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},400,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","The Value of Our Health","The Value of Our Health is a 12-month program. Community health workers (CHWs) lead the first six months of structural and social change activities, followed by six months of store manager and employee-led activities, and technical assistance from CHWs. During the first 6 months, CHWs will work directly with the store staff to plan for structural changes at the store to promote fruit and vegetable (FV) purchasing and consumption. CHWs will deliver store staff training to promote FVs. CHWs will welcome customers into the program at the store by offering social and structural change strategies directed to customers and reinforced by store managers and employees. CHWs will work with employees to deliver a Point of Purchase campaign highlighting recipes and fresh FV sold in the stores. Employees will receive newsletters that reinforce their training. During months 7-12, CHWs will visit the store to support the maintenance of social and structural changes made in the first 6 months.",[38],"Intervention condition",[40],{"measure":41,"description":42,"timeFrame":43},"6-month Fruit and Vegetable Consumption","The validated NCI Fruit and Vegetable (FV) All-Day Screener will be used to measure daily servings of FV consumed in the past month at baseline and at 6-months. The 19-item screener has been used in several large epidemiological and intervention studies is correlated with four 24-hr dietary recalls for both men (r=.59) and women (r=.56). The instrument provides ten response options for each food item ranging from \"never\" to \"5 or more times a day.\" The screener also includes portion-size estimates, which have been shown to increase the accuracy of the estimates in predicting actual FV intake. The screener produces a final continuous score that reflects daily FV servings. Researchers will use food models to assist with portion estimations consistent with previous research.","Baseline, 6-month",[45],{"measure":46,"description":47,"timeFrame":48},"12-month Fruit and Vegetable Consumption","The validated NCI Fruit and Vegetable (FV) All-Day Screener will be used to measure daily servings of FV consumed in the past month at baseline and at 12-months. The 19-item screener has been used in several large epidemiological and intervention studies is correlated with four 24-hr dietary recalls for both men (r=.59) and women (r=.56). The instrument provides ten response options for each food item ranging from \"never\" to \"5 or more times a day.\" The screener also includes portion-size estimates, which have been shown to increase the accuracy of the estimates in predicting actual FV intake. The screener produces a final continuous score that reflects daily FV servings. Researchers will use food models to assist with portion estimations consistent with previous research.","Baseline, 12 months","ALL","18 Years",null,{"inclusion":53,"exclusion":60,"raw_text":61},[54,55,56,57,58,59],"Identify as Latino or Hispanic","Be at least 18 years or older","Live in Benton, Franklin, or Yakima county for at least 6 months and plan to remain there for the next 12 months","Visit this store at least once per week","Be primary household shopper (conducting 50% of shopping duties)","Eat 4 or less servings of fruits and vegetables per week Only one participant per household will be recruited to ensure the independence of observations.",[],"Inclusion criteria:\n\nIn order for an individual to participate in this study, the individual must meet all of the following criteria:\n\n* Identify as Latino or Hispanic\n* Be at least 18 years or older\n* Live in Benton, Franklin, or Yakima county for at least 6 months and plan to remain there for the next 12 months\n* Visit this store at least once per week\n* Be primary household shopper (conducting 50% of shopping duties)\n* Eat 4 or less servings of fruits and vegetables per week Only one participant per household will be recruited to ensure the independence of observations.\n\nExclusion criteria:\n\nSubjects who do not meet the inclusion criteria above will be excluded from the study. If any subject shows 3 or more visual signs of intoxication or impairment, they will be excluded from the study. The study team member will assess visual signs of intoxication during recruitment using the Oregon Liquor \\& Cannabis Commission 50 Signs of Visual Intoxication assessment. A link to these signs can be found here: https:\u002F\u002Fwww.oregon.gov\u002Folcc\u002Fdocs\u002Fpublications\u002F50\\_signs\\_visible\\_intoxication.pdf",[63,64],"ADULT","OLDER_ADULT",[66,88],{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":85},"Northwest Communities Education Center\u002FRadio KDNA","Granger","Washington","98932","United States",[73,78,82],{"name":74,"role":75,"phone":76,"email":77},"Diana Diaz, MS","CONTACT","(509) 854-2222","ddiaz@kdna.org",{"name":79,"role":75,"phone":80,"email":81},"Leonardo Rios, RN","509-854-2222","lrios@kdna.org",{"name":83,"role":84},"Elizabeth Torres, BA","SUB_INVESTIGATOR",{"lat":86,"lon":87},46.34207,-120.18727,{"facility":12,"status":7,"city":89,"state":69,"zip":90,"country":71,"contacts":91,"geoPoint":102},"Seattle","98195",[92,96,99],{"name":93,"role":75,"phone":94,"email":95},"KeliAnne K Hara-Hubbard, MPH","206-616-9071","harak@uw.edu",{"name":97,"role":75,"email":98},"Amy Hernandez, BS","amyh19@uw.edu",{"name":100,"role":101},"Barbara Baquero, PhD","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},47.60621,-122.33207,[106,107],{"name":93,"role":75,"phone":94,"email":95},{"name":97,"role":75,"email":98},[109],{"name":100,"affiliation":12,"role":101},[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[20,114,21],"Chronic disease present",[],{"nct_id":4,"found":14,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This study is an interventional type, meaning participants will receive a specific program. It aims to enroll 400 participants.","completed","Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities","This study, called \"Nuestro Valor,\" is looking at a program called \"The Value of Our Health\" to help people in rural areas eat more fruits and vegetables. The program will be offered in local grocery stores and led by community health workers. To join, you need to identify as Latino or Hispanic, be at least 18 years old, live in Benton, Franklin, or Yakima county for at least six months, visit a participating store at least once a week, and be the main shopper for your household. The main goal is to see if customers who shop at stores using this program eat more fruits and vegetables. The current status of this study is unclear, and it plans to enroll 400 people.","Fruit and vegetable consumption will be measured at the beginning of the study and again at 6 months.",122,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]