[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07126587":3,"trial-entities:NCT07126587":108,"trial-summary:NCT07126587":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":54,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":84,"locations":87,"central_contacts":97,"overall_officials":103,"references":106,"see_also_links":107},"NCT07126587","24-2854","Healthy Living Anson Study","Healthy Living Anson","RECRUITING","2028-03-30","2025-08","2025-10-30","2025-09-24","University of North Carolina, Chapel Hill","OTHER",false,"The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve the quality of their diet compared to participants who receive only physical activity education and coaching.","Purpose: Evaluate whether a Food is Medicine (FIM) intervention improves the quality of food intake among rural adults who have at least one chronic disease or are at risk for chronic disease compared to those receiving a physical activity intervention.\n\nParticipants: English speaking Anson County residents 18 years or older\n\nProcedures: Randomized delayed intervention control study design - 4 months receive either the FIM intervention (healthy frozen meals and\u002For produce box, and education by a Community Health Advocate (CHA) or physical activity (PA) education and support via a CHA. At the end of the 4 months, the FIM group will receive the PA intervention, and the PA group receives the FIM intervention with both groups continuing for another 4 months. Data collected will include a funder required survey (demographics, social, and behavioral factors) plus additional study related questions and biometrics. The survey will be completed online or in person for those requiring internet access or support. The biometrics will be obtained at an in-person session. Once enrollment is complete, participants will be randomized into either the FIM or PA group and receive their study materials. Data collection will occur at baseline, midpoint, and at the end of the study.",[19,20,21,22,23,24],"Obesity (Disorder)","Diabetes Type 2","Heart Disease","Hypertension","Cancer","High Cholesterol",[7,26,27,28,29],"HLA study","nutrition","healthy eating","overweight (BMI ≥ 25)","INTERVENTIONAL","PREVENTION",[33],"NA",{"count":35,"type":36},120,"ESTIMATED",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Nutrition Education and Food Delivery","Healthy frozen meals, produce boxes, and nutrition counseling",[43,44],"Nutrition Education and Food Delivery, Then Physical Activity Comparator","Physical Activity Comparator, Then Nutrition Education and Food Delivery",{"type":39,"name":46,"description":47,"armGroupLabels":48},"Physical Activity Comparator","Physical activity counseling, mHealth text messaging",[43,44],[50],{"measure":51,"description":52,"timeFrame":53},"Med-South Dietary Risk Assessment Score","The Med-South Dietary Risk Assessment (DRA) is scored as the sum of the column score for each numbered item, with column score multiplied by 0.5 for Items 3.3 and 3.4. The score ranges from 0 to 10, 0 meaning no adherence and 10 meaning full adherence. With regard to diet quality, the first response option is considered \"desirable,\" the second \"could be improved,\" and the third \"needs to be improved.","Baseline, Midpoint (Month 4), Endpoint (up to Month 10)",[55,59,63],{"measure":56,"description":57,"timeFrame":58},"Physical Activity Questionnaire","Assessed by the International Physical Activity Questionnaire (IPAQ) - Short Form. This questionnaire is a well-validated 7-day physical activity recall assessment for physical activity. This will measure frequency (days per week) and duration (time per day) for each specific type of activity. Three specific activity types will be scored, walking, moderate-intensity activity, and vigorous-intensity activity. Participants will be scored based on metabolic equivalent of task units (MET, energy expenditure). This will be determined by multiplying the frequency by duration (in hours). Each activity type will have MET calculated separately, and the summation of each score will generate the the overall physical activity score in MET units. Scores will range from 0-99. We will only report the overall score. Higher scores indicate higher levels of physical activity and more energy expenditure.","Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)",{"measure":60,"description":61,"timeFrame":62},"Skin Carotenoids","Description: Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. A Veggie Meter uses reflection spectroscopy to determine the level of skin carotenoids using the fingertip. Measurements are taken three times, with scores being averaged and reported. A higher score indicates more fruit and vegetable intake.","Baseline, Midpoint (month 4), Endpoint (up to month 10)",{"measure":64,"description":65,"timeFrame":66},"Nutrition Insecurity","Nutrition Insecurity will be measured using a survey with one item. This item indicates the frequency in which a participant has skipped or cut the size of meals due to lack of finances. Frequency is established using a likert scale, always to never, with one selection option. Always would signify high nutrition insecurity, and never would signify low nutrition insecurity.","baseline, endpoint","ALL","18 Years","99 Years",true,{"inclusion":72,"exclusion":82,"raw_text":83},[73,74,75,76,77,78,79,80,81],"Potential participants must be a resident of Anson County.","At least 18 years of age.","Have or be at risk for a chronic disease.","Ability to make own dietary decisions.","Ability to travel to a central Anson County location for data collection and group class sessions.","Ability and willingness to try the prepared meals.","Ability to store 10 frozen meals in a freezer.","Ability to communicate in English","No dietary restrictions or food allergies such that a Mediterranean diet is not appropriate.",[],"Inclusion Criteria:\n\n* Potential participants must be a resident of Anson County.\n* At least 18 years of age.\n* Have or be at risk for a chronic disease.\n* Ability to make own dietary decisions.\n* Ability to travel to a central Anson County location for data collection and group class sessions.\n* Ability and willingness to try the prepared meals.\n* Ability to store 10 frozen meals in a freezer.\n* Ability to communicate in English\n* No dietary restrictions or food allergies such that a Mediterranean diet is not appropriate.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599","United States",{"lat":95,"lon":96},35.9132,-79.05584,[98],{"name":99,"role":100,"phone":101,"email":102},"Anissa I Vines, MS, PhD","CONTACT","19198431210","avines@email.unc.edu",[104],{"name":99,"affiliation":13,"role":105},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":115},[110,111,22,112,113,114],"Heart Disorder","Hypercholesterolemia","Malignant Neoplasm","Obesity","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":70,"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 is a randomized study involving 120 participants. You would be assigned to one of two groups: one receiving healthy meals and nutrition education, or one receiving physical activity education.","completed","Healthy Living Anson Study for Chronic Disease Risk","This study, called the Healthy Living Anson Study, is looking at whether healthy meals and nutrition counseling can improve diet quality for adults in Anson County who have or are at risk for chronic diseases like obesity, type 2 diabetes, heart disease, hypertension, or cancer. You would either receive healthy frozen meals, produce boxes, and nutrition counseling, or physical activity counseling and text messages. Researchers will compare changes in your diet quality using a special score (Med-South Dietary Risk Assessment Score) over about 10 months. The study aims to enroll 120 participants and is currently unclear on its recruitment status. To join, you must live in Anson County, be at least 18 years old, and be able to make your own food choices and store frozen meals.","Participants are followed for up to 10 months, with the final assessment at the end of this period.",127,"You would participate for about 10 months, with data collected at the beginning, middle (4 months), and end of the study. This includes surveys and in-person biometric measurements, and potentially attending group classes.","Not stated in the trial record.",[],"v2"]