Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT00841334
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2009-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescents Committed to Nutrition and Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI percentile', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '6 months'}, {'measure': 'Lipids', 'timeFrame': '6 months'}, {'measure': 'Dietary intake', 'timeFrame': '6 months'}, {'measure': 'Blood pressure', 'timeFrame': '6 months'}, {'measure': 'Physical activity', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent', 'Overweight', 'Obesity', 'Weight loss', 'Nutrition', 'Physical activity', 'Community-based participatory research', 'School-based', 'Primary Care', 'Motivational interviewing'], 'conditions': ['Overweight', 'Obesity', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '24379526', 'type': 'DERIVED', 'citation': 'Romaniuk D, Kimsa MW, Strzalka-Mrozik B, Kimsa MC, Kabiesz A, Romaniuk W, Mazurek U. Gene expression of IGF1, IGF1R, and IGFBP3 in epiretinal membranes of patients with proliferative diabetic retinopathy: preliminary study. Mediators Inflamm. 2013;2013:986217. doi: 10.1155/2013/986217. Epub 2013 Nov 28.'}, {'pmid': '23984053', 'type': 'DERIVED', 'citation': 'Sussman AL, Montoya C, Werder O, Davis S, Wallerstein N, Kong AS. An adaptive CBPR approach to create weight management materials for a school-based health center intervention. J Obes. 2013;2013:978482. doi: 10.1155/2013/978482. Epub 2013 Jul 29.'}, {'pmid': '23589771', 'type': 'DERIVED', 'citation': 'Kong AS, Sussman AL, Yahne C, Skipper BJ, Burge MR, Davis SM. School-based health center intervention improves body mass index in overweight and obese adolescents. J Obes. 2013;2013:575016. doi: 10.1155/2013/575016. Epub 2013 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. The intervention will be implemented through school-based health centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. Students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than or equal to the 85th percentile in BMI\n* in 9th through 11th grades at participating schools\n\nExclusion Criteria:\n\n* BMI greater than or equal to 40\n* previously diagnosed type 1 or type 2 diabetes\n* blood pressure in the range of stage 2 hypertension\n* medications that significantly interfere with weight'}, 'identificationModule': {'nctId': 'NCT00841334', 'acronym': 'ACTION', 'briefTitle': 'Adolescents Committed to Nutrition and Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)', 'orgStudyIdInfo': {'id': '08-013'}, 'secondaryIdInfos': [{'id': '5R21HL092533-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21HL092533-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ACTION', 'interventionNames': ['Behavioral: ACTION']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual care', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'ACTION', 'type': 'BEHAVIORAL', 'description': 'Overweight/obese adolescents enrolled in ACTION will meet with SBHC providers over a 6 month period in one school year. SBHC providers will use Motivational Enhancement Therapy to motivate overweight/obese adolescents to adopt strategies for improving nutrition and physical activity.', 'armGroupLabels': ['1']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexio', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Alberta S Kong, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alberta Kong, MD, MPH', 'investigatorAffiliation': 'University of New Mexico'}}}}