Health Without Barriers/Salud Sin Barreras- Northern Colorado
NCT ID: NCT06822387
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
140 participants
INTERVENTIONAL
2025-04-07
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Health Without Barriers/Salud Sin Barreras
NCT06052943
United for Health: Type 2 Diabetes Prevention in Latino Teens
NCT03527641
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
NCT05322876
Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
NCT04035395
Lifestyle Medicine Health Education and Intervention Program "Family Central E-Health"
NCT06934083
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
Physical Activity
Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.
Brief Mindfulness Intervention for Parents
Parent-based mindfulness education is based on the Learning to BREATHE curriculum.
Preschool Curriculum
Preschool age children learn about and try new foods.
Nutrition and Cooking Education
Nutrition education and hands-on cooking lessons for the whole family.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Physical Activity
Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.
Brief Mindfulness Intervention for Parents
Parent-based mindfulness education is based on the Learning to BREATHE curriculum.
Preschool Curriculum
Preschool age children learn about and try new foods.
Nutrition and Cooking Education
Nutrition education and hands-on cooking lessons for the whole family.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between the ages 11-19 years old
* Reside in Larimer County, Weld County, or the surrounding areas.
Parent/guardian subjects:
* 18 years old or older
* Are parents/guardians of an adolescent between the ages of 11-19
* Reside in Larimer County, Weld County, or the surrounding areas
Facilitators subjects
* 18 years old or older
* Reside in Larimer County, Weld County, or the surrounding areas
* Are planning to or have facilitated HWB
Exclusion Criteria
Parents/guardians will not take part in the research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the Colorado State University/Extension program team, could interfere with safety for themselves or others or interfere with the capability of their family or other participating families to potentially benefit from the program (e.g., using drugs or alcohol or under the use of drugs/alcohol during program sessions, aggressive or inappropriate behavior toward other participants).
There is no exclusion for facilitator subjects.
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Colorado State University Extension-Larimer County
UNKNOWN
Colorado State University Extension-Weld County
UNKNOWN
Colorado State University Extension-La Plata County
UNKNOWN
University of Colorado, Denver
OTHER
United States Department of Agriculture (USDA)
FED
Colorado State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lauren B Shomaker, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colorado State University
Fort Collins, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5952
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.