Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 7:00 AM
Study NCT ID:
NCT00121706
Status:
COMPLETED
Last Update Posted:
2006-02-06
First Post:
2005-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Food Feeding in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2006-02-03', 'studyFirstSubmitDate': '2005-07-15', 'studyFirstSubmitQcDate': '2005-07-15', 'lastUpdatePostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy (calorie) intake during fast food feedings, assessed by direct observation'}], 'secondaryOutcomes': [{'measure': 'Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '15199032', 'type': 'BACKGROUND', 'citation': 'Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. JAMA. 2004 Jun 16;291(23):2828-33. doi: 10.1001/jama.291.23.2828.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.', 'detailedDescription': 'Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.\n\n* Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).\n* Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.\n* Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between the 85th and 98th percentiles for sex and age\n* Consumption of fast food at least one time per week\n* Willingness to eat the foods specified in the research methods\n* Parent/guardian willing and able to cooperate\n* Access to a working telephone\n\nExclusion Criteria:\n\n* Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)\n* Taking any prescription medication that may affect food intake\n* Current smoking (i.e., any tobacco in the last month)\n* Previous diagnosis of an eating disorder'}, 'identificationModule': {'nctId': 'NCT00121706', 'briefTitle': 'Fast Food Feeding in Youth', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Fast Food Feeding in Youth', 'orgStudyIdInfo': {'id': 'P30DK040561', 'link': 'https://reporter.nih.gov/quickSearch/P30DK040561', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Condition A (see detailed summary)', 'type': 'BEHAVIORAL'}, {'name': 'Condition B (see detailed summary)', 'type': 'BEHAVIORAL'}, {'name': 'Condition C (see detailed summary)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Cara B Ebbeling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'David S Ludwig, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}]}}}