[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579291":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":80,"collaborators":82,"id":95,"slug":25,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":25,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":121,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Colorado State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Health without Barriers\u002F Salud Sin Barreras (HWB\u002FSSB)","EXPERIMENTAL","HWB\u002FSSB is a community-delivered, whole-family intensive health behavior and lifestyle intervention intended to reduce adolescent risk of chronic diseases (i.e., T2D) through promoting health behaviors and healthy stress management. The program is based on a lifestyle intervention called the Healthy Living Program (HeLP), a family-centered obesity prevention and treatment program for children. Previous and ongoing work has focused on tailoring HWB\u002FSSB implementation to ensure cultural suitability for adolescents and their families in Southwest Colorado.\n\nHWB\u002FSSB emphasizes \"whole family\" involvement including the participation of siblings, elders, other caregivers, and relatives. HWB\u002FSSB is delivered.\n\nThe HWB\u002FSSB intervention delivery is not considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research. The intervention will be delivered regardless of any research activity.",[13,14,15,16,17,18],"Behavioral: Mindfulness-Based Intervention","Behavioral: Parent Education","Behavioral: Physical Activity","Behavioral: Brief Mindfulness Intervention for Parents","Behavioral: Preschool Curriculum","Behavioral: Nutrition and Cooking Education",[20,26,30,34,38,42],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Mindfulness-Based Intervention","Learning to BREATHE (L2B) is an evidence-based mindfulness curriculum for adolescents. L2B in this program consists of 6 sessions of approximately 1 hour per session. In between sessions, participants are asked to practice brief mindfulness skills individually.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Parent Education","The parent education curriculum includes 3 modules: 1) family support\u002Fparenting, 2) nutrition education and 3) physical activity education. Parents set weekly goals to implement what they learned in each session at home with their family.",[9],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Physical Activity","Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.",[9],{"type":21,"name":35,"description":36,"armGroupLabels":37,"otherNames":25},"Brief Mindfulness Intervention for Parents","Parent-based mindfulness education is based on the Learning to BREATHE curriculum.",[9],{"type":21,"name":39,"description":40,"armGroupLabels":41,"otherNames":25},"Preschool Curriculum","Preschool age children learn about and try new foods.",[9],{"type":21,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"Nutrition and Cooking Education","Nutrition education and hands-on cooking lessons for the whole family.",[9],[47],{"name":48,"affiliation":5,"role":49},"Lauren B Shomaker, PhD","PRINCIPAL_INVESTIGATOR",[51,55],{"name":48,"role":52,"phone":53,"phoneExt":25,"email":54},"CONTACT","970-491-3217","lauren.shomaker@colostate.edu",{"name":56,"role":52,"phone":57,"phoneExt":25,"email":58},"Natalia Sanchez, MPH","970-491-1120","natalia.sanchez@colostate.edu",[60],{"facility":5,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Fort Collins","Colorado","80523","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-105.08442,40.58526,{"lat":71,"lon":70},[74,75,79],{"name":56,"role":52,"phone":57,"phoneExt":25,"email":58},{"name":76,"role":52,"phone":77,"phoneExt":25,"email":78},"Vicky Jimenez, BS","970-286-5210","vicky.jimenez@colostate.edu",{"name":48,"role":49,"phone":25,"phoneExt":25,"email":25},{"type":81,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[83,86,88,90,92],{"name":84,"class":85},"Colorado State University Extension-Larimer County","UNKNOWN",{"name":87,"class":85},"Colorado State University Extension-Weld County",{"name":89,"class":85},"Colorado State University Extension-La Plata County",{"name":91,"class":6},"University of Colorado, Denver",{"name":93,"class":94},"United States Department of Agriculture (USDA)","FED","100579291",false,"NCT06822387","Health Without Barriers\u002FSalud Sin Barreras- Northern Colorado","Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment","HWB\u002FSSB","Inclusion Criteria:\n\nAdolescent subjects\n\n* Between the ages 11-19 years old\n* Reside in Larimer County, Weld County, or the surrounding areas.\n\nParent\u002Fguardian subjects:\n\n* 18 years old or older\n* Are parents\u002Fguardians of an adolescent between the ages of 11-19\n* Reside in Larimer County, Weld County, or the surrounding areas\n\nFacilitators subjects\n\n* 18 years old or older\n* Reside in Larimer County, Weld County, or the surrounding areas\n* Are planning to or have facilitated HWB\n\nExclusion Criteria\n\nAdolescents subjects will not take part in the research activities if they have a medical and\u002For psychological\u002Fbehavioral condition that, in the opinion of the Colorado State University\u002FExtension program team, could interfere with safety for themselves or others or interfere with the capability of the participant or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions).\n\nParents\u002Fguardians will not take part in the research activities if they have a medical and\u002For psychological\u002Fbehavioral condition that, in the opinion of the Colorado State University\u002FExtension program team, could interfere with safety for themselves or others or interfere with the capability of their family or other participating families to potentially benefit from the program (e.g., using drugs or alcohol or under the use of drugs\u002Falcohol during program sessions, aggressive or inappropriate behavior toward other participants).\n\nThere is no exclusion for facilitator subjects.",true,"ALL","11 Years",{"count":106,"type":107},140,"ESTIMATED","INTERVENTIONAL",[110],"NA","The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers\u002FSalud Sin Barreras (HWB\u002FSSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB\u002FSSB community facilitator training, evaluating the feasibility and acceptability of HWB\u002FSSB implementation, and characterizing changes in health outcomes among adolescent participants.",[113,114,115,116,117,118,119,120],"Lifestyle Risk Reduction","Adolescent Health","Family Health","Cardio-metabolic Health","Mental Health","Wellness Program","Type 2 Diabetes","Obesity, Adolescent",[122,123,124,125,31,126,127,128],"Whole-family","Mindfulness","Wellness education","Nutrition","Stress reduction","Health Without Barriers","Salud Sin Barreras","2025-04-29",{"date":131,"type":132},"2025-05-02","ACTUAL",{"date":134,"type":132},"2025-04-07",{"date":136,"type":107},"2026-06-30",{"name":5,"class":6},1]