Trials / Recruiting
RecruitingNCT06052943
Health Without Barriers/Salud Sin Barreras
Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- Sponsor
- Colorado State University · Academic / Other
- Sex
- All
- Age
- 11 Years – 19 Years
- Healthy volunteers
- Accepted
Summary
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).
Detailed description
Health Without Barriers/Salud 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/parent training, adolescent physical activity, mindfulness-based stress reduction training for adolescents, family meals, and family cooking/meal 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/implementation 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/Salud Sin Barreras program on changes in a range of indicators of mental/physical health and health behaviors in adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Parent Education | The 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. |
| BEHAVIORAL | Physical Activity | Combines aerobic and resistance training though game play. |
| BEHAVIORAL | Brief Mindfulness Intervention for Parents | Parent-based mindfulness education based on the Learning to BREATHE curriculum. |
| BEHAVIORAL | Preschool Curriculum | Preschool age children learn about and try new foods. |
| BEHAVIORAL | Cooking Matters | Nutrition education and hands-on cooking lessons for the whole family |
Timeline
- Start date
- 2022-09-21
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2023-09-25
- Last updated
- 2025-11-13
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06052943. Inclusion in this directory is not an endorsement.