[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06052943":3,"trial-entities:NCT06052943":152,"trial-summary:NCT06052943":157},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":59,"secondary_outcomes":67,"sex":107,"minimum_age":108,"maximum_age":109,"healthy_volunteers":15,"eligibility_criteria":110,"std_ages":116,"locations":119,"central_contacts":142,"overall_officials":149,"references":150,"see_also_links":151},"NCT06052943","1883","Health Without Barriers\u002FSalud Sin Barreras","Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado","RECRUITING","2027-06","2025-11","2025-11-13","2022-09-21","Colorado State University","OTHER",true,"The goal of this study is to address a key health inequity - lack of community access to evidence-based programs to prevent chronic health conditions (e.g., Type 2 Diabetes) - by tailoring and delivering a family-based lifestyle and stress management intervention, Health Without Barriers\u002FSalud Sin Barreras, for adolescents and their families living in rural Southwest Colorado. The intervention is a lifestyle program that addresses healthy lifestyle habits within the family context to support adolescent mental health (mindfulness intervention) and healthy weight (physical activity, nutrition, and parent education).","Health Without Barriers\u002FSalud Sin Barreras is a 12-session community-delivered, family-based lifestyle intervention for health promotion and reduction of risk for chronic diseases like T2D. The program is delivered over 6 weeks and includes family education\u002Fparent training, adolescent physical activity, mindfulness-based stress reduction training for adolescents, family meals, and family cooking\u002Fmeal preparation. The goal is to deliver the program to up to 175 participants and their families over the course of 5 years (2022-2027). The program content and delivery\u002Fimplementation processes already have been adapted based on information obtained through adolescent and parent interviews and community member voices though a 9-month community research collaboration. The investigators will gather new, additional information from program participants and stakeholders to continue to tailor the curriculum content and program processes. The investigators will do this iteratively using feedback collected during and in the wake of each cohort until thematic saturation is achieved (anticipated to be \\~3 cohorts) and until the community-research partnership group has obtained program optimization for families in Southwest Colorado. Further, the investigators will conduct program evaluations of the adapted Health Without Barriers\u002FSalud Sin Barreras program on changes in a range of indicators of mental\u002Fphysical health and health behaviors in adolescents.",[19,20,21],"Mental Health Wellness","Family Research","Lifestyle Risk Reduction",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},175,"ESTIMATED",[31,39,43,47,51,55],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"BEHAVIORAL","Mindfulness-Based Intervention","Learning 2 BREATHE (L2B) is an evidence based 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.",[36],"Health without Barriers\u002F Salud Sin Barreras",[38],"Learning 2 BREATHE",{"type":32,"name":40,"description":41,"armGroupLabels":42},"Parent Education","The parent education curriculum includes 3 modules: 1) family support\u002Fparenting, 2) nutrition and 3) physical activity. The parents set weekly goals to implement the parent education lessons into everyday living.",[36],{"type":32,"name":44,"description":45,"armGroupLabels":46},"Physical Activity","Combines aerobic and resistance training though game play.",[36],{"type":32,"name":48,"description":49,"armGroupLabels":50},"Brief Mindfulness Intervention for Parents","Parent-based mindfulness education based on the Learning to BREATHE curriculum.",[36],{"type":32,"name":52,"description":53,"armGroupLabels":54},"Preschool Curriculum","Preschool age children learn about and try new foods.",[36],{"type":32,"name":56,"description":57,"armGroupLabels":58},"Cooking Matters","Nutrition education and hands-on cooking lessons for the whole family",[36],[60,64],{"measure":61,"description":62,"timeFrame":63},"Treatment Acceptability: Questionnaire","Participants rate and comment on each component of the program (i.e. Cooking Matters, parent sessions, physical fitness sessions, Learning 2 BREATHE, dinners) separately. Questions include topics about how supported individuals felt during the program, the helpfulness of the facilitators, the perceived benefits of program participation, and their overall experience participating in the program. This questionnaire will only be completed one time at the post-program follow-up.","6 weeks",{"measure":65,"description":66,"timeFrame":63},"Intervention Acceptability: Qualitative Themes","Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.",[68,72,75,78,81,84,87,90,93,96,99,102,105],{"measure":69,"description":70,"timeFrame":71},"Emotion regulation","Difficulties in Emotion Regulation Scale-Short Form (18 items), measures non-acceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.","1 year",{"measure":73,"description":74,"timeFrame":71},"Eating behavior","Reward-Based Eating Drive Scale (REDS), a reliable\u002Fvalid survey instrument of hedonic eating",{"measure":76,"description":77,"timeFrame":71},"24-hour dietary intake","NIH Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in order to assess dietary intake, including total energy intake, macronutrients, fruits\u002Fvegetable consumption, and overall quality of diet.",{"measure":79,"description":80,"timeFrame":71},"Physical activity- engagement","NIH Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Physical Activity - Short Form, measures the number of times an individual engaged in different types of physical activity in the past 7 days.",{"measure":82,"description":83,"timeFrame":71},"Physical activity- self-confidence","Exercise Self-Efficacy Scale, measures an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40 or more minutes per session in the future.",{"measure":85,"description":86,"timeFrame":71},"Sleep disturbance","4-item PROMIS Pediatric Sleep Disturbance Short Form, measures the frequency an individual experienced disturbed sleep in the past 7 days.",{"measure":88,"description":89,"timeFrame":71},"Cardiometabolic health","Finger prick by lancet is used to analyze HbA1c, HDL\u002FLDL cholesterol, and triglycerides.",{"measure":91,"description":92,"timeFrame":71},"Daily glucose patterns","Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.",{"measure":94,"description":95,"timeFrame":71},"Blood Pressure","Blood pressure assessed via digital blood pressure monitor.",{"measure":97,"description":98,"timeFrame":71},"Height and Weight","Weight will be measured via scale and height via stadiometer. These measures are used to calculate BMI percentile. Fasted weight measurement is taken via scale and is optional for participants.",{"measure":100,"description":101,"timeFrame":71},"Body Composition Measurement","Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.",{"measure":103,"description":104,"timeFrame":71},"Activity Monitoring","Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.",{"measure":106,"description":104,"timeFrame":71},"Sleep Monitoring","ALL","11 Years","19 Years",{"inclusion":111,"exclusion":112,"raw_text":115},[],[113,114],"Participants will not take part in the program and\u002For 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) .","Parents\u002Fguardians will not take part in the program and\u002For 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).","Inclusion Criteria:\n\nFamilies must have at least 1 teen that is between the ages of 11-19 years old and reside in La Plata, Montezuma, or Archuleta Counties.\n\nExclusion Criteria:\n\n* Participants will not take part in the program and\u002For 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* Parents\u002Fguardians will not take part in the program and\u002For 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).",[117,118],"CHILD","ADULT",[120,135],{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":132},"Colorado State University Extension","Durango","Colorado","81301","United States",[127],{"name":128,"role":129,"phone":130,"email":131},"Nicole Clark, MS, RDN","CONTACT","970-382-6461","nicole.clark@co.laplata.co.us",{"lat":133,"lon":134},37.27528,-107.88007,{"facility":13,"status":136,"city":137,"state":123,"zip":138,"country":125,"geoPoint":139},"ACTIVE_NOT_RECRUITING","Fort Collins","80523",{"lat":140,"lon":141},40.58526,-105.08442,[143,147],{"name":144,"role":129,"phone":145,"email":146},"Lauren B Shomaker, PhD","970-491-3217","lauren.shomaker@colostate.edu",{"name":148,"role":129,"phone":130,"email":131},"Nicole Clark, RDN",[],[],[],{"nct_id":4,"conditions":153,"biomarkers":156},[154,155],"MENTAL HEALTH WELLNESS 2","Risk Reduction Behavior",[],{"nct_id":4,"found":15,"summary":158,"prompt_version":168},{"design":159,"status":160,"heading":161,"summary":162,"follow_up":163,"word_count":164,"commitments":165,"compensation":166,"drugs_mentioned":167},"This is an interventional study, meaning participants will receive specific interventions. It plans to enroll up to 175 participants and their families over five years.","completed","Health Without Barriers\u002FSalud Sin Barreras for Adolescent Mental Health and Healthy Lifestyles","This study, called Health Without Barriers\u002FSalud Sin Barreras, is looking at a family-based program to help adolescents (ages 11-19) and their families in rural Southwest Colorado improve mental health and reduce risks for chronic diseases like Type 2 Diabetes. The program includes several parts: Learning 2 BREATHE (L2B), a mindfulness program for teens; parent education on family support, nutrition, and physical activity; physical activity through games; brief mindfulness for parents; and a preschool curriculum about new foods. The study wants to see how well families like and accept these interventions. You can join if you have at least one teen between 11 and 19 years old and live in La Plata, Montezuma, or Archuleta Counties. The study is currently recruiting up to 175 participants and their families.","The study measures treatment and intervention acceptability at 6 weeks.",127,"The program involves 12 sessions delivered over 6 weeks. Participants will engage in family education, adolescent physical activity, mindfulness training, family meals, and cooking activities.","Not stated in the trial record.",[40,44,52],"v2"]