Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALMindfulness-Based InterventionLearning 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.
BEHAVIORALParent EducationThe 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.
BEHAVIORALPhysical ActivityCombines aerobic and resistance training though game play.
BEHAVIORALBrief Mindfulness Intervention for ParentsParent-based mindfulness education based on the Learning to BREATHE curriculum.
BEHAVIORALPreschool CurriculumPreschool age children learn about and try new foods.
BEHAVIORALCooking MattersNutrition 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.