Trials / Recruiting

RecruitingNCT06822387

Health Without Barriers/Salud Sin Barreras- Northern Colorado

Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 140 (estimated)

Sponsor: Colorado State University · Academic / Other
Sex: All
Age: 11 Years
Healthy volunteers: Accepted

Summary

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/Salud Sin Barreras (HWB/SSB), 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/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.

Detailed description

Health Without Barriers/Salud Sin Barreras (HWB/SSB) is a 12-session community-delivered, whole-family intensive health behavior and lifestyle intervention for health promotion and reduction of risk for chronic diseases (e.g., type 2 diabetes). The program is delivered over 6 weeks and includes mindfulness-based stress reduction training for adolescents, parent/caregiver health education and mindfulness training, youth physical activity, and whole-family nutrition education and cooking/meal preparation. Previous and ongoing work has focused on gathering and using direct input from local community members and families from Southwest Colorado to adapt HWB/SSB to ensure cultural suitability for teenagers and their families in this region. Now, there is a need for further refinement of HWB/SSB community facilitator training and evaluation of the intervention. The HWB/SSB intervention delivery is NOT considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research (objectives described below). The intervention will be delivered regardless of any research study, and participation in the research study is not a requirement for families to enroll in HWB/SSB or for facilitators to facilitate the intervention. There are three main objectives to this study: 1. Train community-based facilitators for HWB/SSB and refine training through: (a) conducting a series of focus groups with facilitators (up to n=20), (b) facilitator completion of a knowledge tests before and after training, (c) facilitator completion of surveys to evaluate and refine training processes, and (d) monitoring fidelity of HWB delivery through completion of standardized checklists by HWB trainers of mock and live sessions and through facilitator fidelity surveys. 2. Enroll adolescents (up to n=60) and parents/caregivers (up to n=60) from Northern Colorado in HWB/SSB to evaluate the acceptability and feasibility of the program. Program acceptability will be assessed through a series of focus groups and acceptability surveys completed by the participants. Program attendance and retention will be used to assess feasibility. 3. Describe changes in adolescents' psychological, health behavior, and health-related outcomes from before to up to 1-year after HWB/SSB participation. Outcomes include: 1) cardiometabolic health, 2) stress management, 3) enjoyment, self-efficacy, and frequency of physical activity, 4) healthy eating behaviors, and 5) sleep health.

Conditions

Interventions

Type	Name	Description
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.
BEHAVIORAL	Parent Education	The parent education curriculum includes 3 modules: 1) family support/parenting, 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.
BEHAVIORAL	Physical Activity	Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.
BEHAVIORAL	Brief Mindfulness Intervention for Parents	Parent-based mindfulness education is based on the Learning to BREATHE curriculum.
BEHAVIORAL	Preschool Curriculum	Preschool age children learn about and try new foods.
BEHAVIORAL	Nutrition and Cooking Education	Nutrition education and hands-on cooking lessons for the whole family.

Timeline

Start date: 2025-04-07
Primary completion: 2026-06-30
Completion: 2026-06-30
First posted: 2025-02-12
Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06822387. Inclusion in this directory is not an endorsement.