Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-29 @ 6:05 PM
Study NCT ID:
NCT01236794
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2010-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2010-09-14', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': 'About 12 Weeks', 'description': 'Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.'}], 'secondaryOutcomes': [{'measure': 'QOL', 'timeFrame': 'About 12 Weeks', 'description': 'Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22585870', 'type': 'RESULT', 'citation': 'Shaibi GQ, Konopken Y, Hoppin E, Keller CS, Ortega R, Castro FG. Effects of a culturally grounded community-based diabetes prevention program for obese Latino adolescents. Diabetes Educ. 2012 Jul-Aug;38(4):504-12. doi: 10.1177/0145721712446635. Epub 2012 May 14.'}, {'pmid': '21461141', 'type': 'RESULT', 'citation': 'Shaibi GQ, Greenwood-Ericksen MB, Chapman CR, Konopken Y, Ertl J. Development, implementation, and effects of community-based diabetes prevention program for obese latino youth. J Prim Care Community Health. 2010 Oct 1;1(3):206-12. doi: 10.1177/2150131910377909.'}, {'pmid': '23576420', 'type': 'RESULT', 'citation': 'Ryder JR, Vega-Lopez S, Ortega R, Konopken Y, Shaibi GQ. Lifestyle intervention improves lipoprotein particle size and distribution without weight loss in obese Latino adolescents. Pediatr Obes. 2013 Oct;8(5):e59-63. doi: 10.1111/j.2047-6310.2013.00162.x. Epub 2013 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.', 'detailedDescription': 'With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hispanic Ethnicity (Child and Parent)\n* Age 14-16 (Child) and Parent age \\< 85\n* BMI Percentile above the 85th (child)\n* Ability to read and speak English (child)\n\nExclusion Criteria:\n\n* Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))\n* Involved in any formal weight-loss program in the past 6 months (Child)\n* Diagnosed diabetes (type 1 or type 2 Child)\n* Weight is less than 110 Ibs (Child and Parent)'}, 'identificationModule': {'nctId': 'NCT01236794', 'acronym': 'ELSC', 'briefTitle': 'Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts', 'orgStudyIdInfo': {'id': 'P20MD002316ELSC'}, 'secondaryIdInfos': [{'id': 'P20MD002316', 'link': 'https://reporter.nih.gov/quickSearch/P20MD002316', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle and Exercise Intervention', 'interventionNames': ['Behavioral: Lifestyle Education Sessions and Youth Exercise Sessions']}], 'interventions': [{'name': 'Lifestyle Education Sessions and Youth Exercise Sessions', 'type': 'BEHAVIORAL', 'otherNames': ['ELSC', 'Every Little Step Counts'], 'description': 'The intervention will include a \\~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (\\~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.', 'armGroupLabels': ['Lifestyle and Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85287', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'St. Vincent de Paul Medical and Dental Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}