Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT07229508
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developmental Trajectories of Reinforcer Pathology and Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'zBMI', 'timeFrame': '0, 12, 24 and 36 months', 'description': 'Height and weight will be measured to determine zBMI using the CDC extended BMI-for-age growth charts. First, height (m) and weight (kg) will be used to calculate BMI (kg/m\\^2), then, using the CDC extended BMI-for-age growth charts, a zBMI score will be determined based on the charts.'}, {'measure': 'body fat', 'timeFrame': '0, 12, 24 and 36 months', 'description': 'Body fat (% of body weight) will be measured using the Tanita BF-400 Total Body Analyzer.'}, {'measure': 'percent change over the overweight BMI', 'timeFrame': '0, 12, 24 and 36 months', 'description': 'Height and weight will be measured to calculate changes in overweight status of children. Change in percent overweight from 0, 12, 24, 36 months. First, height and weight will be used to calculate BMI (kg/m\\^2), then CDC extended growth charts will be used to determine BMI percentile. Percent overweight is calculated as ((childBMI percentile - 85th BMI percentile)/(85th BMI percentile)) x 100. Percent over the age- and sex- specific 85th BMI percentile for children will be used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reinforcer Pathology Theory', 'Reinforcing Value', 'Delay Discounting'], 'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to understand how children's food preferences, physical activity, and decision-making change over time and how these behaviors relate to body weight and overall health.", 'detailedDescription': 'A cohort sequential design will be used to track 2 cohorts of children aged 8.5-9 years 11 months, and 10.5-11 years 11 months over a 3 year period to understand how the development of food and activity reinforcement and delay discounting could lead to the development of childhood obesity in children aged 9-14.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female children of varying racial/ethnic backgrounds, SES backgrounds, and varying body compositions', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female children\n* Black, Indigenous, and People of Color (BIPOC) or Hispanic families\n* Children from low SES families (as defined by household education, eligibility for government assistance)\n* Children in overweight/obese category (defined by range in each cohort)\n\nExclusion Criteria:\n\n* Medical causes for obesity\n* Stature below the 5th percentile\n* Physical activity restrictions\n* Psychopathology\n* Medication use that affects activity or appetite\n* Children that spend less than 65% of their time in participating parent's household\n* BMI percentile criteria\n* Liking of study foods and activities\n* Dietary restrictions and food allergies"}, 'identificationModule': {'nctId': 'NCT07229508', 'acronym': 'TRACK', 'briefTitle': 'Developmental Trajectories of Reinforcer Pathology and Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Trajectories of Reinforcement, Activity, and Consumption in Kids', 'orgStudyIdInfo': {'id': 'STUDY00008702'}, 'secondaryIdInfos': [{'id': '1R01DK139258-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK139258-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aged 8.5-9', 'description': 'Children that are enrolled when they are 8.5- 9 years, 11 months of age'}, {'label': 'Aged 10.5-11', 'description': 'Children that are enrolled when they are 10.5-11 years, 11 months age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary J Hite, BA', 'role': 'CONTACT', 'email': 'maryjohi@buffalo.edu', 'phone': '7168292261'}, {'name': 'Katelyn Carr, PhD', 'role': 'CONTACT', 'email': 'kcarr@buffalo.edu', 'phone': '7168296814'}, {'name': 'Leonard H Epstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State University of New York at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Mary J Hite, BA', 'role': 'CONTACT', 'email': 'maryjohi@buffalo.edu', 'phone': '7168292261'}, {'name': 'Katelyn Carr, PhD', 'role': 'CONTACT', 'email': 'kcarr@buffalo.edu', 'phone': '7168296814'}], 'overallOfficials': [{'name': 'Leonard H Epstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY-University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leonard Epstein', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}