[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657800":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":51,"overallOfficials":31,"centralContacts":57,"locations":63,"responsibleParty":78,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":31,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":31,"enrollmentInfo":96,"targetDuration":31,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":111,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Skin carotenoid scores","Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)","Baseline, 12-weeks, and 6-months.",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Dietary Intake","Dietary intake will be calculated using the Healthy Eating Index (HEI)-2020","Baseline, 6-months",{"measure":19,"description":20,"timeFrame":17},"Depression","Symptoms of depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9)",{"measure":22,"description":23,"timeFrame":24},"Anxiety","Symptoms of anxiety will be measured using the 7-item Generalized Anxiety Disorder (GAD-7).","Baseline, 6-month",{"measure":26,"description":27,"timeFrame":17},"Food security status","Food security status will be measured using the USDA Adult Food Security Survey Module",{"measure":29,"description":30,"timeFrame":17},"Nutrition security status","The Center for Nutrition and Health Impact 4-item nutrition security screener will be used.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","A critical research gap of FIM is objective, non-invasive measures of dietary intake for rigorously evaluating interventions, such as produce prescription programs. The Veggie Meter® is a research-grade tool strongly correlated with plasma carotenoid levels that utilizes pressure-mediated reflection spectroscopy to rapidly detect carotenoids in the skin, correcting for melanin concentration across skin tones, to estimate V\u002FF intake over 30 days. Carotenoids are fat-soluble compounds found ubiquitously in V\u002FF, detectable in the diet, plasma, and body tissues and may contain bioactive properties that have been demonstrated to slow the progression of chronic disease development. Carotenoid status may serve as a comprehensive, objective, and non-invasive measures of dietary intake that has yet to be implemented in the evaluation of FIM. In addition to being ideally suited for evaluating the effectiveness of FIM, the Veggie Meter® may serve as a promising tool to incorporate into primary care for better assessing dietary intake for prevention and treatment of diet-related chronic diseases. With dietary intake and behavioral lifestyle modifications at the core of chronic disease management, understanding the role of nutritional monitoring in primary care on initiating and sustaining patient health-related behavior change is essential to reduce disease prevalence and severity.\n\nThe specific aims of the project are:\n\nAim 1: Evaluate whether participants in a FIM intervention have higher skin carotenoid scores compared to those not in a FIM intervention over 6 months.\n\nAim 2: Determine whether informing participants of their skin carotenoid scores at baseline is effective for increasing diet quality at 6 months compared to not receiving skin carotenoid scores. Participants and controls (n=150) will be randomized to receive skin carotenoid scores and their clinical lab values (HbA1c, lipids, BP, anthropometrics) or to only receive their clinical lab values.\n\nAim 3: Examine barriers and facilitators of integrating objective, non-invasive nutritional monitoring into primary care using a convergent mixed methods design.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Bite-sized Biomarkers: Knowledge of skin carotenoid scores","EXPERIMENTAL","Participants will be randomized to receive their skin carotenoid scores at baseline.",[45],"Behavioral: Bite-sized Biomarkers: Skin carotenoid scores",{"label":47,"type":48,"description":49,"interventionNames":50},"Bite-sized Biomarkers: Masked to Skin Carotenoid Scores","ACTIVE_COMPARATOR","Participants will be randomized to be masked to their skin carotenoid values until the follow-up visit.",[45],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":31},"BEHAVIORAL","Bite-sized Biomarkers: Skin carotenoid scores","In this intervention, participants will be randomized to either receive or be masked to additional information on their nutritional status by measuring skin carotenoid scores as a proxy of fruit and vegetable intake to see if knowledge of status at baseline leads to more dietary behavior change.",[41,47],[58],{"name":59,"role":60,"phone":61,"phoneExt":31,"email":62},"Marcela Radtke, PhD","CONTACT","650-260-4767","mdradtke@stanford.edu",[64],{"facility":5,"status":31,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Palo Alto","California","94114","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-122.14302,37.44188,{"lat":74,"lon":73},[77],{"name":59,"role":60,"phone":61,"phoneExt":31,"email":62},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Marcela Radtke","Postdoctoral Research Fellow",[83],{"name":84,"class":85},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100657800","bite-sized-biomarkers-100657800",false,"NCT07845383","Bite Sized Biomarkers","Bite Sized Biomarkers: Promoting Health Behavior Change Through Objective Dietary Monitoring","Inclusion Criteria:\n\n* adults (18 years or older)\n* at risk for food insecurity (affirmative response to one or more questions on the Huger Vital Signs\n* at risk or experiencing a nutrition-sensitive chronic conditions (e.g., obesity, type 2 diabetes, MASLD, hypertension, etc.)\n* able to read and write in English or Spanish\n\nExclusion Criteria:\n\n* planned relocation within the study window\n* currently pregnant or plans to become pregnant within the study window\n* unable to provide informed consent",true,"ALL","18 Years",{"count":97,"type":98},150,"ESTIMATED","INTERVENTIONAL",[101],"NA","The primary objective of this study is to rigorously evaluate the effectiveness of a Food is Medicine (FIM) intervention using objective biomarkers and to determine the role of nutritional monitoring on the impact and sustainability of integrating nutrition supports into primary care.",[104,105,106],"Dietary Assessment","Diet, Food, and Nutrition","Carotenoid Status",[108,109,110],"Skin carotenoids","Food is Medicine","Nutritional monitoring","NOT_YET_RECRUITING","2026-09-21",{"date":114,"type":115},"2026-09-28","ACTUAL",{"date":117,"type":98},"2026-10-05",{"date":119,"type":98},"2028-07-28",{"name":5,"class":6},1]