[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06970067":3,"trial-entities:NCT06970067":102,"trial-summary:NCT06970067":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":70,"central_contacts":92,"overall_officials":99,"references":100,"see_also_links":101},"NCT06970067","HSC-SPH-23-1139","Co-Creating Active Middle School Communities to Increase Student Physical Activity","Co-Creating and Implementing Contextually Responsive Physical Activity Interventions With Middle School Adolescents","RECRUITING","2028-12-31","2025-12","2026-05-11","2026-03-02","Deanna Hoelscher","OTHER",null,"The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.","Early adolescence is a critical window of opportunity for establishing lifelong physically active lifestyles. During this stage, youth seek autonomy and experience independent mobility. However, steep declines in physical activity occur in adolescence, a trend that continues into adulthood. This is partly due to reduced opportunities for structured exercise and sports in later life relative to childhood. Despite this, most school-based interventions heavily focus on physical education, sports participation, and active recess strategies (i.e., leisure), with less emphasis on promoting utilitarian (transport-based) physical activity.\n\nInterventions prioritizing the entire school community (including students, their families, and school neighborhood residents), and focused on increasing active transport and leisure, might have a more significant and sustainable impact over the lifespan. To be effective and contextually responsive, however, intervention development, implementation, and evaluation must be collaboratively conducted with and through local community members.\n\nThis project proposes to conduct a comprehensive and community-engaged mixed methods study to design and test strategies for improving community-wide and individual-level physical activity outcomes in middle school neighborhoods. The specific aims of this study are:\n\nAim 1. To identify community-level barriers and facilitators for physical activity in middle school communities using a comprehensive mixed methods approach (Delphi method with Group Concept Mapping, geospatial analysis, participatory GIS).\n\nAim 2. To engage multi-sectoral and multi-generational community actors for co-creating contextually-responsive intervention strategies to improve access to active transport and leisure in middle school communities.\n\nAim 3. To conduct a first-generation, controlled trial testing the effectiveness of the co-created intervention strategies for improving physical activity outcomes in middle school communities.\n\nHypothesis 3.1. 12-month pre-post change in daily minutes of moderate- to vigorous-intensity physical activity (MVPA) will be higher among middle school students (grades 6-7) in school communities that implement co-created strategies relative to comparison school communities.\n\nHypothesis 3.2 (exploratory). Community-based physical activity levels will improve at 12 months in intervention school communities, relative to comparison school communities.\n\nHypothesis 3.3. (exploratory). The intervention will improve community-level outcomes, including enhanced community norms regarding active travel, collective efficacy for physical activity, and perceived neighborhood traffic and crime safety.\n\nIf successful, these strategies can be scaled up to help increase physical activity among middle school children and communities in the U.S. Increased physical activity among middle school youth can lead to higher levels of physical activity throughout the lifespan, potentially decreasing or attenuating chronic diseases.",[19],"Physical Activity",[21,22,23,24,25],"physical activity","adolescent health","active transport","active leisure","middle school","INTERVENTIONAL","PREVENTION",[29],"NA",{"count":31,"type":32},450,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Active Middle School Communities","This intervention will engage multi-sectoral and multi-generational community members and middle school students to co-produce (co-design, co-implementation, and co-evaluation) contextually-responsive intervention strategies to improve access to active transport and leisure, resulting in increased physical activity and decreased risk for chronic disease in middle school communities. This intervention will use community-based participatory methods, with resources provided for changes in the built environment around the school catchment area.",[39],"Physical activity intervention co-produced by the community and investigators",[41],{"measure":42,"description":43,"timeFrame":44},"Child\u002Fadolescent physical activity","Measured using Accelerometry to determine minutes of moderate-to-vigorous physical activity (MVPA)","Baseline, 12 months (initial effectiveness), and 24 months (sustainability)",[46],{"measure":47,"description":48,"timeFrame":49},"Percentage of children\u002Fadolescents using active transport to\u002Ffrom school","Measured using Active Commuting to School Tallies to obtain counts of children\u002Fadolescents who walk or bike to or from school compared to all children\u002Fadolescents","Data will be collected for 4 years in both fall and spring each year (Years 2-5) for 8 data points.","ALL","11 Years","99 Years",true,{"inclusion":55,"exclusion":62,"raw_text":65},[56,57,58,59,60,61],"Parent\u002Fguardian and child\u002Fadolescent dyads","Child\u002Fadolescent must be enrolled in the 6th grade at participating schools at baseline","Parent\u002Fguardian and child\u002Fadolescent must reside in the same household","Parent\u002Fguardian and child\u002Fadolescent must reside within the school catchment area (school community)","Parent\u002Fguardian must speak English or Spanish","Child\u002Fadolescent must speak English",[63,64],"Child\u002Fadolescent has a condition that precludes or decreases participation in physical activity","Child\u002Fadolescent cannot complete a written survey","Inclusion Criteria:\n\n* Parent\u002Fguardian and child\u002Fadolescent dyads\n* Child\u002Fadolescent must be enrolled in the 6th grade at participating schools at baseline\n* Parent\u002Fguardian and child\u002Fadolescent must reside in the same household\n* Parent\u002Fguardian and child\u002Fadolescent must reside within the school catchment area (school community)\n* Parent\u002Fguardian must speak English or Spanish\n* Child\u002Fadolescent must speak English\n\nExclusion Criteria:\n\n* Child\u002Fadolescent has a condition that precludes or decreases participation in physical activity\n* Child\u002Fadolescent cannot complete a written survey",[67,68,69],"CHILD","ADULT","OLDER_ADULT",[71],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":89},"The University of Texas Health Science Center at Houston","Austin","Texas","78701","United States",[78,83,87],{"name":79,"role":80,"phone":81,"email":82},"Deanna M Hoelscher, PhD","CONTACT","5123912510","Deanna.M.Hoelscher@uth.tmc.edu",{"name":84,"role":80,"phone":85,"email":86},"Sarah S Bentley, MPH","+1 (512) 482 6152","Sarah.S.Bentley@uth.tmc.edu",{"name":79,"role":88},"PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},30.26715,-97.74306,[93,95],{"name":79,"role":80,"phone":94,"email":82},"(512) 391-2510",{"name":96,"role":80,"phone":97,"email":98},"Deborah Salvo, PhD","408-386-5614","dsalvo@austin.utexas.edu",[],[],[],{"nct_id":4,"conditions":103,"biomarkers":104},[19],[],{"nct_id":4,"found":53,"summary":106,"prompt_version":115},{"design":107,"status":108,"heading":6,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This interventional study plans to enroll 450 participants. It involves a behavioral intervention called Active Middle School Communities.","completed","This study, called \"Active Middle School Communities,\" aims to understand and improve physical activity levels in middle school students. Researchers will work with community members, families, and students to create and test new strategies to make it easier for kids to be active, both for fun and for getting around (like walking or biking to school). The goal is to see if these community-based approaches can increase physical activity and keep those improvements going over time. You and your middle school child (6th grader) might be able to join if you live in the school's area and speak English or Spanish. The study will measure physical activity at the start, after 12 months, and again after 24 months to see how well the strategies work.","Participants' physical activity will be measured at the beginning, after 12 months, and again after 24 months.",125,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]