Health Without Barriers/Salud Sin Barreras- Northern Colorado

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT06822387
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
11 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mindfulness-Based Intervention — BEHAVIORAL
    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.
  • Parent Education — BEHAVIORAL
    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.
  • Physical Activity — BEHAVIORAL
    Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.
  • Brief Mindfulness Intervention for Parents — BEHAVIORAL
    Parent-based mindfulness education is based on the Learning to BREATHE curriculum.
  • Preschool Curriculum — BEHAVIORAL
    Preschool age children learn about and try new foods.
  • Nutrition and Cooking Education — BEHAVIORAL
    Nutrition education and hands-on cooking lessons for the whole family.

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Health without Barriers/ Salud Sin Barreras (HWB/SSB)
    HWB/SSB is a community-delivered, whole-family intensive health behavior and lifestyle intervention intended to reduce adolescent risk of chronic diseases (i.e., T2D) through promoting health behaviors and healthy stress management. The program is based on a lifestyle intervention called the Healthy Living Program (HeLP), a family-centered obesity prevention and treatment program for children. Previous and ongoing work has focused on tailoring HWB/SSB implementation to ensure cultural suitability for adolescents and their families in Southwest Colorado. HWB/SSB emphasizes "whole family" involvement including the participation of siblings, elders, other caregivers, and relatives. HWB/SSB is delivered. The HWB/SSB intervention delivery is not considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research. The intervention will be delivered regardless of any research activity.

Primary Outcome Measure

Intervention Fidelity: Observer Session Ratings [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Colorado State UniversityFort CollinsColorado80523
Natalia Sanchez, MPH
[email protected]
970-491-1120
Vicky Jimenez, BS
[email protected]
970-286-5210
Lauren B Shomaker, PhD (PRINCIPAL_INVESTIGATOR)

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Colorado State University· Fort Collins, CO

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