Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01221220
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
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', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2010-10-13', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '18 months post randomization'}], 'secondaryOutcomes': [{'measure': 'Waist Circumference', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Triceps skinfold', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Resting heart rate', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Dietary intake/ meals eaten with television', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Weight concerns', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Daily energy intake', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Physical Activity', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Fasting blood lipids, insulin/glucose metabolism', 'timeFrame': '6 months and 18 months post randomization'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '6 months post randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. The investigators propose to test these methods when added to a current state-of-the-art behavioral program.', 'detailedDescription': 'Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion criteria: 8-15 year old obese children (BMI \\≥ 95th percentile on the 2000 CDC BMI reference) on the date of randomization. Our standard Stanford Pediatric Weight Control Program eligibility criteria will apply: both child and parent/guardian must want to join, both child and at least one parent/guardian must agree to attend sessions, and must agree to not miss more than 2 consecutive sessions. As we interested in testing generalizable strategies for weight control in diverse populations, the eligibility criteria are designed to be liberal, to maximize the generalizability of the results, but also maintain the internal validity of the test of the intervention. Exclusion Criteria:Exclusions: To enhance internal validity, children will not be eligible if they:\n\n1. have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder \\[present or past\\], AIDS or HIV infection, pregnancy);\n2. are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);\n3. have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);\n4. have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language);\n5. are unable to read, understand or complete informed consent in English or Spanish;\n6. plan to move from the San Francisco Bay Area within the next 18 months.'}, 'identificationModule': {'nctId': 'NCT01221220', 'briefTitle': 'Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children', 'orgStudyIdInfo': {'id': 'SU-08302010-6809'}, 'secondaryIdInfos': [{'id': 'R01HL096015', 'link': 'https://reporter.nih.gov/quickSearch/R01HL096015', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Treatment', 'description': 'Six-month, family-based, group, behavioral weight control program', 'interventionNames': ['Behavioral: Standard Packard Pediatric Weight Control Program']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral Treatment plus Environmental Strategies', 'description': 'Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention', 'interventionNames': ['Behavioral: Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes']}], 'interventions': [{'name': 'Standard Packard Pediatric Weight Control Program', 'type': 'BEHAVIORAL', 'description': 'Six-month, family-based, group, behavioral weight control program', 'armGroupLabels': ['Behavioral Treatment']}, {'name': 'Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes', 'type': 'BEHAVIORAL', 'description': 'Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention', 'armGroupLabels': ['Behavioral Treatment plus Environmental Strategies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Thomas Robinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Irving Schulman, MD Endowed Professor in Child Health; Professor of Pediatrics and of Medicine and CHP/PCOR Associate', 'investigatorFullName': 'Thomas Robinson', 'investigatorAffiliation': 'Stanford University'}}}}