Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-21 @ 11:56 PM
Study NCT ID:
NCT03797105
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency Needed for School-based Obesity Intervention
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Standardized Body Mass Index (zBMI)', 'timeFrame': 'baseline, 6, and 12 months', 'description': 'standardized body mass index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Child']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.', 'detailedDescription': 'Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BMI-for-age (Body Mass Index) percentile ≥ 85\n2. Male or female between ages 10 - 17 years\n3. Self-identified as Mexican-American\n\nExclusion Criteria:\n\n1. Student who is pregnant, planning to become pregnant, or becomes pregnant\n2. School report of cognitive impairment significantly below average age and/or grade level\n3. Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening\n4. Type 1 or 2 diabetes medical diagnosis'}, 'identificationModule': {'nctId': 'NCT03797105', 'briefTitle': 'Frequency Needed for School-based Obesity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'STUDY00000487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control, 0 days', 'description': 'control group, no intervention'}, {'type': 'EXPERIMENTAL', 'label': '1 day', 'description': 'received the intervention 1 day/week', 'interventionNames': ['Behavioral: School-Based Obesity Intervention (FLOW)']}, {'type': 'EXPERIMENTAL', 'label': '3 days', 'description': 'received the intervention 3 days/week', 'interventionNames': ['Behavioral: School-Based Obesity Intervention (FLOW)']}, {'type': 'EXPERIMENTAL', 'label': '5 days', 'description': 'received the intervention 5 days/week', 'interventionNames': ['Behavioral: School-Based Obesity Intervention (FLOW)']}], 'interventions': [{'name': 'School-Based Obesity Intervention (FLOW)', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.', 'armGroupLabels': ['1 day', '3 days', '5 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77031', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'YES Prep Brays Oaks', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Craig A Johnston, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Craig A Johnston', 'investigatorAffiliation': 'University of Houston'}}}}