Health Without Barriers/Salud Sin Barreras- Northern Colorado

NCT06822387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

  • Lifestyle Risk Reduction
  • Adolescent Health
  • Family Health
  • Cardio-metabolic Health
  • Mental Health
  • Wellness Program
  • Type 2 Diabetes
  • Obesity, Adolescent

Interventions

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.

Sponsors & Collaborators

  • Colorado State University Extension-Larimer County

    collaborator UNKNOWN
  • Colorado State University Extension-Weld County

    collaborator UNKNOWN
  • Colorado State University Extension-La Plata County

    collaborator UNKNOWN
  • University of Colorado, Denver

    collaborator OTHER
  • United States Department of Agriculture (USDA)

    collaborator FED
  • Colorado State University

    lead OTHER

Principal Investigators

  • Lauren B Shomaker, PhD · Colorado State University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822387 on ClinicalTrials.gov