[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657442":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":67,"studyPopulation":67,"armGroups":73,"interventions":86,"overallOfficials":67,"centralContacts":94,"locations":100,"responsibleParty":113,"collaborators":67,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":67,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":67,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":138,"overallStatus":148,"whyStopped":67,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Arizona State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":57},[9,13,17,20,23,26,29,32,35,38],{"measure":10,"description":11,"timeFrame":12},"Gut Microbiome Diversity","Microbial DNA extracted from toddler stool samples will undergo shotgun metagenomic sequencing to identify the unique species present in the gut microbial community and evaluate the richness and abundance of microbes present in the stool.","At enrollment to the end of treatment at 12 months",{"measure":14,"description":15,"timeFrame":16},"Toddler length","Toddler length will be assessed with a pediatric length board and reported in centimeters.","From enrollment to the end of treatment at 12 months",{"measure":18,"description":19,"timeFrame":16},"Toddler weight","Infant weight will be assessed with a calibrated scale and reported in grams.",{"measure":21,"description":22,"timeFrame":16},"Vineland Adaptive Behavior Scale (Vinland-3)","A questionnaire completed by the parent\u002Fcaregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.",{"measure":24,"description":25,"timeFrame":16},"McArthur Bates Communicative Development Inventories III (MBCDI-III)","A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.",{"measure":27,"description":28,"timeFrame":16},"Mullen Scales of Early Learning","Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.",{"measure":30,"description":31,"timeFrame":16},"Brief Infant Sleep Questionnaire - Extended","Sleep location, duration, quality, and interactions; validated for infants and toddlers through age 3 years; REDCap online. Scores range from 0-100 with higher scores representing healthier, more consolidated sleep patterns (e.g., shorter time to fall asleep, fewer and shorter night wakings).",{"measure":33,"description":34,"timeFrame":16},"Sleep-Wake Patterns measured by actigraphy (time awake and asleep)","Actigraphy is a standard, valid, noninvasive measure for assessing sleep and circadian rhythm patterns across the life course. For infants and young children (e.g., toddlers), the actigraph is a small watch-like device that will be worn around the left ankle to record body motion (activity counts). The child will wear the devices for 7 continuous days and nights after all in-home visits. Constant assessment is necessary to capture the full development of sleep-wake patterns and circadian rhythmicity across toddlerhood. Home visits will be scheduled to avoid current illnesses or well-visits to avoid vaccination effects on sleep patterns. Primary sleep variables will be averaged across the recording period. Data will be reported in minutes of time that the child is awake or asleep.",{"measure":36,"description":37,"timeFrame":16},"Parent-Reported Sleep-Wake Patterns (time awake and asleep, and number of naps and perceived quality of sleep episodes)","During actigraphy data collection, the parent\u002Fguardian will complete sleep diaries on the sleep of their toddler. Diaries will be used to identify artifacts that might affect motion (externally induced motion e.g. car seat, swing, or constricted motion e.g. swaddling), and to define sleep periods from actigraphy outputs for children prior to analysis with the sleep-wake algorithms. Primary sleep diary variables will be (1) bed\u002Fnap clock times attempted to sleep, (2) bed\u002Fnap clock times of sleep bout awakenings, and (3) time in bed or interval between attempted bed and wake times.",{"measure":39,"description":40,"timeFrame":16},"Home Observation for Measurement of the Environment Inventory (quality and extent of stimulation, support, and learning resources in the home)","Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment. The inventory qualitatively assesses the quality and extent of stimulation, support, and learning resources available in a child's home environment.",[42,45,48,51,54],{"measure":43,"description":44,"timeFrame":16},"Infant 24-hour Diet Records","Habitual intake will be assessed via the Automated Self-Administered 24-hr recall software (ASA24) on 2 weekdays and one weekend day developed by the National Cancer Institute.",{"measure":46,"description":47,"timeFrame":16},"Food intake photos showing the infant consuming intervention foods (compliance measure)","Pre-post meal photos of the infant and their food will be provided by the parents. These images will be used to help corroborate dietary intake and behavior data.",{"measure":49,"description":50,"timeFrame":16},"Centers for Disease Control Infant Feeding Questionnaire to assess feeding practices in toddlerhood","This questionnaire asks about breastfeeding, formula feeding, complementary feeding, introduction to solid foods, food allergies, and participation in the Special Supplemental Nutrition Assistance Program for Women, Infant, and Children.",{"measure":52,"description":53,"timeFrame":16},"Food Security Screener","The USDA 6-Item Food Security Screener will be used to assess household food insecurity. Scores range from 0-6 with higher scores representing higher levels of food insecurity.",{"measure":55,"description":56,"timeFrame":16},"Comprehensive Early Childhood Allergy Questionnaire","Will be used to evaluate allergy exposures and risk across the study period. This is a checklist of various common allergies that parents report the child having or not having each allergy.",[58,61],{"measure":59,"description":60,"timeFrame":16},"Stool Consistency","Parents will be asked to classify the stool consistency using the picture-based Brussels Infant and Toddler Stool Scale (BITSS), developed specifically for non-toilet-trained children.",{"measure":62,"description":63,"timeFrame":16},"Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers","To assess children's experiences of gastrointestinal and gastroesophageal reflux symptoms. A total score is calculated as a sum of responses from 36 questions. Higher scores indicate greater symptom burden, and scores range from 0 to 180",{"allocation":65,"interventionModel":66,"interventionModelDescription":67,"primaryPurpose":68,"observationalModel":67,"timePerspective":67,"maskingInfo":69},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":70,"maskingDescription":67,"whoMasked":71},"SINGLE",[72],"OUTCOMES_ASSESSOR",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Cow's Milk","EXPERIMENTAL","Toddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1\u002F2 cup)).",[79],"Other: Daily cow's milk products",{"label":81,"type":82,"description":83,"interventionNames":84},"Oat Milk","ACTIVE_COMPARATOR","Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup fluid oat milk) + ½ cup equivalent of oat-based cheese (0.75 oz.) or yogurt (1\u002F2 cup)).",[85],"Other: Daily Oat Milk Exposure",[87,90],{"type":6,"name":88,"description":77,"armGroupLabels":89,"otherNames":67},"Daily cow's milk products",[75],{"type":6,"name":91,"description":92,"armGroupLabels":93,"otherNames":67},"Daily Oat Milk Exposure","Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1\u002F2 cup)).",[81],[95],{"name":96,"role":97,"phone":98,"phoneExt":67,"email":99},"Corrie M Whisner, PhD","CONTACT","602-496-3348","cwhisner@asu.edu",[101],{"facility":5,"status":67,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":67},"Phoenix","Arizona","85004","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-112.07404,33.44838,{"lat":111,"lon":110},{"type":114,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100657442","tiny-tummies---a-milk-study-100657442",false,"NCT07839156","Tiny Tummies - A Milk Study","Beyond the Bottle: Investigating the Differential Biological Effects of Cow's Milk and Oat Milk on Toddler Development","Inclusion Criteria:\n\n* Children born to mothers 18 years and older while pregnant\n* Parents speak English and\u002For Spanish\n* At least one caregiver in the home must have at least an 8th-grade education level\n* Children still being breastfed into toddlerhood will be eligible to participate. Breastfeeding frequency and duration will be tracked in this case for statistical model adjustment.\n\nExclusion Criteria:\n\n* Children regularly taking probiotics and\u002For antibiotics (e.g., due to chronic ear infections)\n* Children with known allergies to cow's milk or oat products\n* Children introduced to fluid cow's or oat milk prior to 12 months of age however, yogurt and cheese made from cow's or oat milk will be acceptable and will be quantified for model adjustment during statistical analyses\n* Children born with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development\n* Children born with congenital abnormalities or developmental delays\n* Children born with birth weights \\\u003C2500 g or \\>4000 g\n* Biological mothers must have no known substance use during the child's pregnancy (alcohol, tobacco, marijuana, or illegal drugs)\n* Biological mothers who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.) that affected child growth\n* A family history of dairy or gluten (oats are sometimes contaminated with gluten) allergies will be evaluated to assess the child's risk. If either the child's mother or father is allergic to dairy and\u002For gluten, physician clearance for child participation will be needed\n* The toddler's biological parents have heritable diseases that could influence the findings (e.g., autism).",true,"ALL","6 Months","12 Months",{"count":127,"type":128},150,"ESTIMATED","INTERVENTIONAL",[131],"NA","This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents\u002Fday of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.",[134,135,136,137],"Gut Microbiome","Neurocognitive Correlates of Eating Habits","Infants and Young Children","Sleep",[139,140,141,142,143,144,145,146,147],"milk","oatmilk","toddlers","growth","development","gut microbiome","neurocognitive","brain health","sleep","NOT_YET_RECRUITING","2026-09-18",{"date":151,"type":152},"2026-09-24","ACTUAL",{"date":154,"type":128},"2026-09-15",{"date":156,"type":128},"2031-01-30",{"name":5,"class":6},1]