[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551777":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":12,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":12,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Vanderbilt University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Whole Foods Counseling Group","NO_INTERVENTION","Participants randomized to the \"usual care\" group will receive a MyPlate Plan that follows a conventional Dietary Guidelines for Americans (DGA) diet which is considered a healthy diet pattern for adolescents with obesity. This diet intervention will encourage the consumption of a whole foods \"dietary patterns\" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. Physical activity will be encouraged per MyPlate guidelines and will be reported on the MyPlate plan daily. At the end of each week, study personnel and\u002For the study RDN will follow up with the participants to review the food checklists. At this time personnel will address diet-related questions and provide guidance on diet adherence.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Whole Foods MyPlate Group","EXPERIMENTAL","Adolescents and adults randomized to the \"intervention group\" will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs. The 8-week intervention will consist of rotating menus (per above) and bi-weekly groceries of mostly fruits and vegetables delivered to family's homes that align with the study menus to support adherence.",[18],"Behavioral: Whole Foods MyPlate Group",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","Families will receive 4-weeks of rotating menus that have been designed as a part of our preliminary work and will be adapted to support adherence with the adolescent in mind (e.g., school lunch options, on-the-go snacks). Menus and diet recommendations will align with the current macronutrient nutritional goals outlined by the 2020-2025 DGA for age-sex groups. Participants will be encouraged to eat ad libitum (i.e., as desired until full) without calorie restrictions. MyPlate will be used by participants to implement the diet. During the study, adolescents and adults in the intervention group will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs.",[14],[25],{"name":26,"affiliation":5,"role":27},"Nadia M Sneed, PhD, MSN","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","615-343-1542","nadia.sneed@vanderbilt.edu",{"name":34,"role":30,"phone":12,"phoneExt":12,"email":12},"Daien Sanchez, MA",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Vanderbilt University School of Nursing","RECRUITING","Nashville","Tennessee","37240","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.78444,36.16589,{"lat":48,"lon":47},[51,55],{"name":52,"role":30,"phone":53,"phoneExt":12,"email":54},"Bryn Evans, MMHC, PMP","615-343-3290","bryn.evans@vanderbilt.edu",{"name":56,"role":30,"phone":57,"phoneExt":12,"email":58},"Gay Nell Krauss, MPA, CRA","615-343 6070","gaynell.krauss@Vanderbilt.Edu",{"type":27,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Nadia Markie Sneed","Principal Investigator",[63],{"name":64,"class":6},"Vanderbilt University Medical Center","100551777","whole-foods-for-teens-a-pilot-dietary-intervention-to-reduce-body-adiposity-in-adolescents-with-obesity-100551777",false,"NCT06464497","Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity","Inclusion Criteria:\n\nFor this study, eligible adolescents will be those that:\n\n1. 10-18 years of age at time of initial screening;\n2. living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);\n3. obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;\n4. reside within greater Middle Tennessee area and has enrolled parent\u002Fcaregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);\n6. are willing and able to participate in an 8-week diet study that encourages preparing and eating healthy foods and snacks for 8 weeks with parental or caregiver support;\n7. have parental or caregiver commitment to participate in the research study;\n\nFor this study, eligible adult parents or caregivers will be those that:\n\n1. adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;\n2. live with the adolescent full-time (≥80% in primary residence);\n3. have 1 or more metabolic risk factor(s) and\u002For metabolic condition(s) (e.g., overweight\u002Fobesity, hypertension, hypercholesterolemia or dyslipidemia, hyperglycemia \\[elevated fasting blood glucose ≥100 mg\u002FdL\\] and\u002For prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease);\n4. reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups);\n6. are able to participate in a study program that encourages preparing and eating healthy foods and snacks for 8 weeks with most preparation\u002Fcooking of meals\u002Fsnacks at home;\n\nExclusion Criteria:\n\nAdolescent exclusion criteria include:\n\n1. Outside of the specified age range;\n2. not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);\n3. BMI less than 95th percentile for age and gender;\n4. pregnant or lactating;\n5. no eligible enrolled parent or caregiver or lack of parental\u002Fcaregiver commitment to participate in study;\n6. food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;\n7. use of medications that cause weight loss or diabetes medications;\n8. active participation in a weight loss or intense lifestyle modification program;\n9. limited English-language proficiency;\n10. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n11. adolescents who display dissenting behaviors during baseline data collection;\n12. adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nAdult Parent or Caregiver exclusion criteria include:\n\n1. not parent\u002F or legal caregiver;\n2. not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);\n3. lack of metabolic condition(s) per inclusion criteria;\n4. special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n5. limited English-language proficiency;\n6. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n7. parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","ALL","10 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study will address the following aims:\n\nAim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity.\n\nAim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention.\n\nHypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group.\n\nAim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention.\n\nHypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and\u002For waist circumference at the 8-week follow-up than those in the control group.\n\nSecondary Aims:\n\nAim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period.\n\nHypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group.\n\nAim 3: Conduct post-intervention family focus groups to identify how individual\u002Ffamily needs and preferences and social determinants of health (SDOH) may be perceived barriers and\u002For facilitators of diet adherence to a whole foods diet pattern.",[81,82,83],"Obesity, Childhood","Diet, Healthy","Body Weight Changes","2026-03-18",{"date":86,"type":87},"2026-03-23","ACTUAL",{"date":89,"type":87},"2025-03-24",{"date":91,"type":75},"2027-04-30",{"name":5,"class":6},1]