[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558262":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":61,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":29,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":43,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"George Washington University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (Group 1)","ACTIVE_COMPARATOR","Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention.",[13],"Behavioral: Control Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"NNS Restriction in Lactation (Group 2)","Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.",[18,13],"Behavioral: NNS Restriction Intervention",{"label":20,"type":10,"description":21,"interventionNames":22},"NNS Restriction in Pregnancy and Lactation (Group 3)","Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","NNS Restriction Intervention","Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy\u002Flactation may have unfavorable effects on infants' adiposity and health.\n\nProvide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS.\n\nEmphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead.\n\nBi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages.\n\nAutomated text messages will also be sent to mothers once per week with reminders that they should avoid NNS",[15,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Control Intervention","Counsel about best practices for home safety and babyproofing.\n\nProvide a detailed booklet to take home, which will provide information about home safety and baby proofing.\n\nEducate about common causes of accidental infant and young child injuries or death.\n\nAutomated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.",[9,15],[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Allison C Sylvetsky, PhD","CONTACT","202-994-5602","asylvets@gwu.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The George Washington University","RECRUITING","Washington D.C.","District of Columbia","20037","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.03637,38.89511,{"lat":53,"lon":52},[56],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Allison Sylvetsky (Meni)","Associate Professor",[62,64,66],{"name":63,"class":6},"Children's Hospital Los Angeles",{"name":65,"class":6},"Children's National Research Institute",{"name":67,"class":68},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100558262","effects-of-a-non-nutritive-sweetener-reduction-intervention-in-pregnancy-and-lactation-on-maternal-and-infant-outcomes-100558262",false,"NCT06548828","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)","Inclusion Criteria:\n\n* Pregnant\n* ≤ 16 weeks gestation\n* Singleton pregnancy\n* Report frequent NNS beverage consumption (≥ 7 servings\u002Fweek)\n* 18-45 years of age\n* Able to read English at a 5th grade level; and\n* Intend to breastfeed for at least the first 6 months of life.\n* For infants: The mother must be enrolled and provide assent for the infant to participate.\n\nExclusion Criteria:\n\n* Physical or mental concerns preventing study participation;\n* Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;\n* Tobacco or drug use during pregnancy;\n* Alcohol consumption (\\>1 drink per week) during pregnancy;\n* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;\n* Known suspected\u002Fconfirmed genetic fetal abnormalities or suspected or known congenital birth defects.\n* History of prior gastric bypass surgery.",true,"FEMALE","18 Years","45 Years",{"count":81,"type":82},324,"ESTIMATED","INTERVENTIONAL",[85],"NA","The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and\u002For lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.",[88,89,90],"Gestational Diabetes Mellitus in Pregnancy","Glucose Intolerance During Pregnancy","Non-nutritive Sweeteners Consumption in Pregnancy and\u002For Lactation",[92,93,94,95,96,97,98],"Non-nutritive sweeteners (NNS)","Pregnancy","Lactation","Infant fat mass","Gestational diabetes (GDM)","Glucose tolerance","PeaPod","2026-02-16",{"date":101,"type":102},"2026-02-18","ACTUAL",{"date":104,"type":102},"2024-08-19",{"date":106,"type":82},"2029-02-01",{"name":5,"class":6},1]