[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634834":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":26,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":26,"enrollmentInfo":102,"targetDuration":26,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":132,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Hawaii","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Community Health Worker Navigated Produce Prescription (Intervention Arm)","EXPERIMENTAL","Produce Prescription program and 1-on-1 Community Health Worker navigation sessions.",[13],"Behavioral: Community Health Worker navigated Produce Prescription",{"label":15,"type":16,"description":17,"interventionNames":18},"Produce Prescription Only (Control Arm)","ACTIVE_COMPARATOR","Produce Prescription program only",[19],"Behavioral: Produce Prescription Only",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Produce Prescription Only","Participants in the Control Arm receive a 12-month Produce Prescription program only. This includes the same $100 monthly vouchers to buy fresh fruits and vegetables at a local retailer (or produce box of the same value) as the intervention arm, but no bi-monthly 1-on-1 sessions with the Community Health Worker (CHW). Participants will receive 1 monthly reminder from the CHW to use vouchers each month",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Community Health Worker navigated Produce Prescription","Participants in the Intervention Arm receive a 12-month Community Health Worker (CHW) navigated Produce Prescription program, including $100 monthly vouchers to buy fresh fruits and vegetables at a local retailer (or produce box of the same value). In addition to the vouchers, this group receives at minimum, bi-monthly, 1-on-1 sessions with a trained CHW (at least 6 sessions total). CHWs will use motivational interviewing and goal setting to drive behavior change, connect participants to community resources, and provide access to reputable nutrition information to help debunk misinformation. They will use their understanding of the local community to provide relevant support. This guidance is designed to overcome barriers to voucher redemption and encourage positive health behaviors as a result of being in the program.",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Monica K Esquivel","CONTACT","(808) 956-8691","monicake@hawaii.edu",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Cherese M Kwan","chereses@hawaii.edu",[41,59,73],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hāmākua-Kohala Health Center","Honokaa","Hawaii","96727","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-155.46691,20.07931,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":26,"email":58},"Cathy Marquette","808-930-2737","cmarquette@hamakua-health.org",{"facility":60,"status":26,"city":61,"state":44,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Waianae Coast Comprehensive Health Center","Waianae","96792",{"type":49,"coordinates":64},[65,66],-158.18555,21.43785,{"lat":66,"lon":65},[69],{"name":70,"role":34,"phone":71,"phoneExt":26,"email":72},"May Okihiro","(808) 697-3433","okihirom@hawaii.edu",{"facility":74,"status":26,"city":75,"state":44,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Waimānalo Health Center","Waimanalo","96795",{"type":49,"coordinates":78},[79,80],-157.7238,21.34614,{"lat":80,"lon":79},[83],{"name":84,"role":34,"phone":85,"phoneExt":26,"email":86},"Mary Oneha","808-259-7948","moneha@waimanalohealth.org",{"type":88,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[90],{"name":91,"class":92},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100634834","navigating-hypertension-and-food-insecurity-100634834",false,"NCT07544836","Navigating Hypertension and Food Insecurity","Navigating Hypertension and Food Insecurity: A Produce Prescription Program to Improve Health Outcomes for Native Hawaiian and Pacific Islander Communities","Inclusion Criteria:\n\n* patient of the participating health center clinic\n* age 20 years and older\n* positive screen for food insecurity using a validated two-question tool\n* physician diagnosed HTN and continued indications of SBP \\>130 mmHG\n\nExclusion Criteria:\n\n* prior history of cardiovascular disease\n* unable to provide informed consent and complete study procedures in English","ALL","20 Years",{"count":103,"type":104},250,"ESTIMATED","INTERVENTIONAL",[107],"NA","This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness.\n\nThe study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and\u002For the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities.\n\nTo test the effectiveness of the added CHW support, there will be two groups of participants:\n\nGroup 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges.\n\nGroup 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW.\n\nThe investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes.\n\nUpon providing informed consent and enrolling into the program, produce prescription program participants will:\n\n* Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months.\n* Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure.\n* Answer surveys about their demographic background, health habits, diet, and culture.\n* Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer.\n* Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program.\n* Group 2 will receive monthly reminders to use their vouchers but no CHW meetings.\n\nAfter the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.",[110,111],"Hypertension (HTN)","Food Insecurity",[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"hypertension","high blood pressure","produce prescription","food insecurity","cardiovascular disease prevention","community health worker","fruit and vegetable vouchers","Randomized Controlled Trial","Community-Based Participatory Research","Social Determinants of Health","cost-effectiveness analysis","Native Hawaiian health","Pacific Islander health","Federally Qualified Health Center","Food as Medicine","Hypertension self-management support","cost-effectiveness","healthcare cost reduction analysis","quality-adjusted life year","NOT_YET_RECRUITING","2026-05-18",{"date":135,"type":136},"2026-05-20","ACTUAL",{"date":138,"type":104},"2026-09-01",{"date":140,"type":104},"2028-03",{"name":5,"class":6},3]