[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658335":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":76,"studyPopulation":63,"armGroups":77,"interventions":90,"overallOfficials":100,"centralContacts":104,"locations":113,"responsibleParty":130,"collaborators":133,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":63,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":169,"whyStopped":63,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Prairie View A&M University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":63},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Body Weight","Change in measured body weight, expressed in kilograms (kg), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.","Baseline, 6 weeks, and 12 weeks",{"measure":14,"description":15,"timeFrame":12},"Change in Healthy Eating Index (HEI)-2020 Total Score","Change in Healthy Eating Index (HEI)-2020 total score derived from participants' dietary intake data collected using 24-hour dietary recalls. HEI-2020 scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to the Dietary Guidelines for Americans.",{"measure":17,"description":18,"timeFrame":12},"Change in Fasting Blood Glucose","Change in fasting blood glucose concentration, expressed in milligrams per deciliter (mg\u002FdL), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.",[20,23,26,29,32,35,38,41,44,47,51,54,57,60],{"measure":21,"description":22,"timeFrame":12},"Change in Hemoglobin A1C (HbA1C)","Change in haemoglobin A1C concentration, expressed as a percentage of total haemoglobin (%), as a measure of long-term glycemic control.",{"measure":24,"description":25,"timeFrame":12},"Change in Body Fat Percentage","Change in body fat percentage (%) measured using body composition assessment methods.",{"measure":27,"description":28,"timeFrame":12},"Change in Skeletal Muscle Mass","Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods. Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods.",{"measure":30,"description":31,"timeFrame":12},"Change in Waist Circumference","Change in waist circumference, expressed in centimeters (cm), measured using standardized anthropometric procedures.",{"measure":33,"description":34,"timeFrame":12},"Change in Body Mass Index (BMI)","Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg\u002Fm²).",{"measure":36,"description":37,"timeFrame":12},"Change in Average Daily Step Count","Change in average daily step count measured using a pedometer.",{"measure":39,"description":40,"timeFrame":12},"Change in Energy Expenditure","Change in activity-related energy expenditure, expressed in kilocalories per day (kcal\u002Fday), measured using a pedometer or activity-monitoring device.",{"measure":42,"description":43,"timeFrame":12},"Change in Blood Pressure","Change in Change in systolic and diastolic blood pressure measurements, expressed in millimeters of mercury (mmHg), measured using standardized procedures.",{"measure":45,"description":46,"timeFrame":12},"Change in Lipid Profile","Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations, expressed in milligrams per deciliter (mg\u002FdL).",{"measure":48,"description":49,"timeFrame":50},"Program Compliance","Percentage of prescribed nutrition counseling activities, dietary recommendations, and physical activity recommendations completed by participants during the intervention period.","Throughout study completion (up to 12 weeks)",{"measure":52,"description":53,"timeFrame":50},"Participant Recruitment Rate","Percentage of eligible individuals who enroll in the study among all individuals screened for participation.",{"measure":55,"description":56,"timeFrame":50},"Participant Retention Rate","Percentage of enrolled participants who complete all study assessments through the end of the intervention period.",{"measure":58,"description":59,"timeFrame":50},"Participant Satisfaction Questionnaire Score","Participant satisfaction with the intervention measured using a study-specific satisfaction questionnaire. The level of satisfaction will be scored on a likert scale.",{"measure":61,"description":62,"timeFrame":50},"Program Favorability Questionnaire Score","Participant perceptions of the intervention measured using a study-specific program favorability questionnaire. Scores will be on a likert scale that reflects perceptions of the intervention.",null,{"allocation":65,"interventionModel":66,"interventionModelDescription":67,"primaryPurpose":68,"observationalModel":63,"timePerspective":63,"maskingInfo":69},"RANDOMIZED","PARALLEL","Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. Both groups will be followed concurrently throughout the study, and outcomes will be compared between groups.","TREATMENT",{"masking":70,"maskingDescription":71,"whoMasked":72},"TRIPLE","Participants will be informed that they would follow a healthy eating pattern, however the type of diet of each arm will not be revealed. Given the behavioral and educational nature of the intervention, only personnel providing education and counseling will be aware of the study group assignment.",[73,74,75],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Obesity and prediabetes are major public health concerns and disproportionately affect under-supported populations, including African American and Hispanic\u002FLatino communities. Traditional nutrition interventions often use a one-size-fits-all approach and may not adequately account for individual variability in biological, behavioral, and environmental factors that influence health outcomes. Precision nutrition is an emerging approach that tailors nutrition recommendations to individual characteristics such as dietary intake, physical activity, health status, genotype, phenotype, psychosocial influences, and environmental exposures. Advances in nutrition science, artificial intelligence, and machine learning have created opportunities to integrate these factors and deliver more personalized dietary and lifestyle recommendations. The purpose of this study is to determine whether a culturally sensitive precision nutrition intervention can improve obesity and type 2 diabetes risk factors among African American and Hispanic\u002FLatino adults living in Texas. The study will recruit adults aged 18 to 65 years with overweight, obesity, and\u002For prediabetes. Participants will be randomized to either an intervention group or a control group. The intervention group will receive tailored nutrition counseling, individualized meal planning, physical activity guidance, behavior-change education, and access to a mobile-health platform to support healthy lifestyle modification. The intervention will incorporate motivational interviewing techniques and social support resources. The control group will receive standard nutrition counseling and educational materials. Data collection will occur at baseline, 6 weeks, and 12 weeks. Measures will include sociodemographic information, dietary intake, food security, anthropometric and body composition assessments, physical activity, blood pressure, fasting blood glucose, hemoglobin A1C, lipid profile, genetic markers, gut microbiome measures, inflammatory markers, and cognitive assessments. Qualitative interviews and focus group discussions will be used to explore participant experiences and intervention acceptability. Primary outcomes include changes in body weight, diet quality, and fasting blood glucose. Secondary outcomes include changes in hemoglobin A1C, body composition, blood pressure, lipid profile, physical activity levels, feasibility, acceptability, compliance, and sustainability of intervention effects. Findings from this study will provide preliminary evidence regarding the effectiveness and feasibility of precision nutrition approaches for obesity and diabetes prevention in under-supported populations.",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"Precision Nutrition Intervention","EXPERIMENTAL","Participants will receive a culturally sensitive precision nutrition intervention including individualized nutrition counseling, personalized meal planning, physical activity guidance, health behavior lessons, mobile-health support, motivational interviewing, and social support resources.",[83],"Behavioral: Precision Nutrition Intervention",{"label":85,"type":86,"description":87,"interventionNames":88},"Standard Nutrition Counseling Control","ACTIVE_COMPARATOR","Participants will receive standard nutrition counseling and dietary education materials without individualized precision nutrition recommendations.",[89],"Behavioral: Standard Nutrition Counseling",[91,95],{"type":92,"name":79,"description":93,"armGroupLabels":94,"otherNames":63},"BEHAVIORAL","A personalized precision nutrition program tailored to participants' dietary habits, physical activity, socioeconomic characteristics, psychosocial factors, phenotype, and genotype. The intervention includes nutrition counseling, physical activity guidance, behavioral education, mobile-health support, and social support activities.",[79],{"type":92,"name":96,"description":97,"armGroupLabels":98,"otherNames":99},"Standard Nutrition Counseling","Standard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices.",[85],[85],[101],{"name":102,"affiliation":5,"role":103},"Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,","PRINCIPAL_INVESTIGATOR",[105,109],{"name":102,"role":106,"phone":107,"phoneExt":63,"email":108},"CONTACT","9362612536","jaantwi@pvamu.edu",{"name":110,"role":106,"phone":111,"phoneExt":63,"email":112},"Obed Akwaa Harrison, PhD, MSc(R), RNutr.","9362612522","oaharrison@pvamu.edu",[114],{"facility":115,"status":63,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"integrated Nutrition Intervention for Community and Health Enhancement Laboratory (iNICHE Lab)","Prairie View","Texas","77446","United States","US",{"type":122,"coordinates":123},"Point",[124,125],-95.98773,30.09327,{"lat":125,"lon":124},[128,129],{"name":102,"role":106,"phone":107,"phoneExt":63,"email":108},{"name":102,"role":103,"phone":63,"phoneExt":63,"email":63},{"type":103,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Janet Antwi","Associate Professor",[134],{"name":135,"class":136},"United States Department of Agriculture (USDA)","FED","100658335","precision-nutrition-for-obesity-and-prediabetes-prevention-in-under-supported-communities-100658335",false,"NCT07850531","Precision Nutrition for Obesity and Prediabetes Prevention in Under-supported Communities","Building Capacity in Precision Nutrition to Address Obesity and Diabetes in Underserved Communities","PNOD","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* African American or Hispanic\u002FLatino adults\n* Residents of Texas\n* Body mass index (BMI) ≥ 25 kg\u002Fm² and\u002For fasting blood glucose levels of 100-125 mg\u002FdL\n* Hemoglobin A1C (HbA1C) between 5.7% and 6.4%\n* Daily access to a cell phone and the internet\n* Able to participate in moderate-to-vigorous physical activity\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Do not meet the inclusion criteria\n* Following a prescribed diet for any reason, including weight loss, within the previous 3 months\n* Diagnosed diabetes mellitus\n* Cardiovascular disease\n* Eating disorders\n* Lung disease\n* Liver disease\n* Thyroid disease\n* Crohn's disease\n* Pregnant\n* Lactating","ALL","18 Years","65 Years",{"count":149,"type":150},100,"ESTIMATED","INTERVENTIONAL",[153],"NA","This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic\u002FLatino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.",[156,157],"Obesity & Overweight","Prediabetes",[159,160,161,162,163,164,165,166,167,157,168],"Precision Nutrition","Personalized Nutrition","Weight Loss","Diabetes Prevention","Nutrition Counseling","Physical Activity","Culturally Sensitive Intervention","African American Adults","Hispanic\u002FLatino Adults","Obesity","NOT_YET_RECRUITING","2026-09-24",{"date":172,"type":173},"2026-09-30","ACTUAL",{"date":175,"type":150},"2026-10-01",{"date":177,"type":150},"2027-08-31",{"name":5,"class":6},1]