Health Without Barriers/Salud Sin Barreras
Part of paid clinical trials in Durango, Colorado.
- Sponsor
- Colorado State University
- Study ID
- NCT06052943
- Status
- Recruiting
Conditions
- Family Research
- Lifestyle Risk Reduction
- Mental Health Wellness
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 19 Years
- Healthy Volunteers
- Accepted
Interventions
- Mindfulness-Based Intervention — BEHAVIORALLearning 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.
- Parent Education — BEHAVIORALThe parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition and 3) physical activity. The parents set weekly goals to implement the parent education lessons into everyday living.
- Physical Activity — BEHAVIORALCombines aerobic and resistance training though game play.
- Brief Mindfulness Intervention for Parents — BEHAVIORALParent-based mindfulness education based on the Learning to BREATHE curriculum.
- Preschool Curriculum — BEHAVIORALPreschool age children learn about and try new foods.
- Cooking Matters — BEHAVIORALNutrition education and hands-on cooking lessons for the whole family
Study Details
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/Salud 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).
Key Dates
- Start date
- Sep 21, 2022
- Status verified
- Nov 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 175 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Health without Barriers/ Salud Sin BarrerasHealth Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Primary Outcome Measure
Treatment Acceptability: Questionnaire [ Time Frame: 6 weeks ]
Central Contacts
- Lauren B Shomaker, PhD970-491-3217
- Nicole Clark, RDN970-382-6461
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Colorado State University Extension | Durango | Colorado | 81301 | |
| Colorado State University | Fort Collins | Colorado | 80523 | - |
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