[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553196":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":12,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":12,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Vanderbilt University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Whole Foods Counseling Group (Control)","NO_INTERVENTION","Participants randomized to the control group will receive dietetic counseling sessions (weeks 1-2) on the 2020-2025 Dietary Guidelines for Americans (DGA) which is considered a healthy diet pattern for prediabetes. Diet adherence will be assessed with 3-day food diary in weeks 1-12. Study personnel and\u002For the study RDN will follow up with the participants during the study to review the food diaries.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Whole Foods Healthy Eating Group (Intervention)","EXPERIMENTAL","The 12-week whole foods intervention consists of 2 phases. The feeding phase (weeks 1-8) is comprised of an intensive 2-week controlled feeding period followed by a 6-week partial feeding period. This diet intervention will encourage the consumption of a whole foods \"dietary pattern\". The maintenance phase (weeks 9-12) is a 4-week \"free-living\" period to assess intervention feasibility without food provision or dietetic support.",[18],"Behavioral: Whole Foods for Families",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Whole Foods for Families","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. During the partial feeding period (weeks 3-8), families will be asked to continue the whole foods diet with support that includes: 1) 3 weekly dinners of the families' choosing (described above), 2) rotating menus (\\~3 weeks' worth) that will allow for customization (e.g., protein, vegetable, grain swaps) to support cultural\u002Fdietary preferences, and 3) dietetic support to help with customization and diet maintenance. Participants will be instructed by the registered dietitian nutritionist (RDN) on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled families in the study, the goal is to maintain complete diet adherence during the twelve-week intervention.",[14],[26],{"name":27,"affiliation":5,"role":28},"Nadia M Sneed, PhD, MSN","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Nadia M. Sneed, PhD, MSN","CONTACT","615-343-1542","nadia.sneed@vanderbilt.edu",{"name":36,"role":32,"phone":12,"phoneExt":12,"email":12},"Kylee Vecchi, MS",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Vanderbilt University School of Nursing","RECRUITING","Nashville","Tennessee","37240","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-86.78444,36.16589,{"lat":50,"lon":49},[53,57],{"name":54,"role":32,"phone":55,"phoneExt":12,"email":56},"Bryn Evans, MMHC, PMP","615-343-3290","bryn.evans@vanderbilt.edu",{"name":58,"role":32,"phone":59,"phoneExt":12,"email":60},"Gay Nell Krauss, MPA, CRA","615-343 6070","gaynell.krauss@Vanderbilt.Edu",{"type":28,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Nadia Markie Sneed","Principal Investigator",[65],{"name":66,"class":6},"Vanderbilt University Medical Center","100553196","whole-food-for-families-a-pilot-rct-of-a-dietary-guidelines-based-intervention-to-prevent-type-2-diabetes-100553196",false,"NCT06482944","Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes","Inclusion Criteria:\n\nFor this study, eligible adults will be those that:\n\n1. are 25 to 59 years of age at time of initial screen and identify as a parent to at least one child or adolescent 6-18 years;\n2. have a body mass index of between ≥23kg\u002Fm2 to \\\u003C40kg\u002Fm2;\n3. have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg\u002FdL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test \\[OGTT\\] 140 mg\u002FdL to 199 mg\u002FdL) with recent lab values reported within the prior 6-12 months and confirmed by an HbA1c A1cNow+ collected prior to enrollment (\\*see comment below);\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. are English speaking;\n6. reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;\n7. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n8. are able to participate in a 12-week dietary program that requires home preparation\u002Fcooking for meals and snacks;\n\nFor this study, eligible offspring will be those that:\n\n1. Are 6-18 years at time of initial screen;\n2. Have an index parent with prediabetes that is actively enrolled in the program;\n3. have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. have parental commitment to participate in a 12-week research study\n6. are English speaking;\n7. reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- week study;\n8. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n9. are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;\n\nExclusion Criteria:\n\nAdult exclusion criteria include:\n\n1. Adults who's HbA1c test is outside of the HbA1c range during screening\\* (see details related to screening results)\n2. adults outside the specified age range of \\\u003C25 years or \\>59 years;\n3. adults whose body mass index is \\\u003C23kg\u002Fm2 or those with a body mass index ≥40kg\u002Fm2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);\n4. receiving care by a healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management\u002Ftreatment;\n5. adults actively participating in any type of weight loss program (dietary or physical activity)\n6. adults with a prior history of type 2 diabetes;\n7. adults who are not English speaking or have limited English-language proficiency;\n8. adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n9. adults with serious mental or neurologic illness that impairs the ability to consent\u002Fparticipate;\n10. women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;\n11. adults currently taking medications to treat diabetes or to promote weight loss;\n12. adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;\n13. adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nOffspring (child\\[ren\\] and adolescent\\[s\\]) exclusion criteria include:\n\n1. children\u002Fadolescents outside the specified age range of \\\u003C6 years or \\>18 years;\n2. children\u002Fadolescents whose body mass index is \\\u003C5th percentile for age and gender on standardized CDC growth curves;\n3. children\u002Fadolescents who do not have an eligible index parent participating in the study;\n4. children who do not have parental commitment to participate consistently for 12-weeks\n5. children\u002Fadolescents who are not English speaking or have limited English-language proficiency;\n6. children\u002Fadolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n7. children\u002Fadolescents who display dissenting behaviors during baseline data collection;\n8. children\u002Fadolescents actively participating in any type of weight loss program (medical or lifestyle);\n9. children\u002Fadolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","ALL","6 Years","59 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study will address the following aims:\n\nAim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet.\n\nFeasibility: ≥80% participant retention and completion of study outcome measures.\n\nAcceptability: ≥75 adult diet satisfaction via survey report and\u002For perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult\u002Fchild diet quality during the 12-week intervention.\n\nAim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.\n\nHypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group.\n\nAim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group.\n\nAim 3: Conduct family focus groups to understand how SDOH and individual\u002Ffamily needs and preferences may be perceived barriers or facilitators of diet adherence.",[84,85,86],"PreDiabetes","Diet, Healthy","Nutritional and Metabolic Diseases","2026-03-05",{"date":89,"type":90},"2026-03-06","ACTUAL",{"date":92,"type":90},"2025-10-13",{"date":94,"type":78},"2027-06-30",{"name":5,"class":6},1]