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Recruiting NCT06822387

NCT06822387 Health Without Barriers/Salud Sin Barreras- Northern Colorado

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Clinical Trial Summary
NCT ID NCT06822387
Status Recruiting
Phase
Sponsor Colorado State University
Condition Lifestyle Risk Reduction
Study Type INTERVENTIONAL
Enrollment 140 participants
Start Date 2025-04-07
Primary Completion 2026-06-30

Eligibility & Interventions

Sex All sexes
Min Age 11 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Mindfulness-Based InterventionParent EducationPhysical Activity

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 140 participants in total. It began in 2025-04-07 with a primary completion date of 2026-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion Criteria: Adolescent subjects * 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 Adolescents subjects 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 the participant or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions). 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.

Contact & Investigator

Central Contact

Lauren B Shomaker, PhD

✉ lauren.shomaker@colostate.edu

📞 970-491-3217

Principal Investigator

Lauren B Shomaker, PhD

PRINCIPAL INVESTIGATOR

Colorado State University

Frequently Asked Questions

Who can join the NCT06822387 clinical trial?

This trial is open to participants of all sexes, aged 11 Years or older, studying Lifestyle Risk Reduction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06822387 currently recruiting?

Yes, NCT06822387 is actively recruiting participants. Contact the research team at lauren.shomaker@colostate.edu for enrollment information.

Where is the NCT06822387 trial being conducted?

This trial is being conducted at Fort Collins, United States.

Who is sponsoring the NCT06822387 clinical trial?

NCT06822387 is sponsored by Colorado State University. The principal investigator is Lauren B Shomaker, PhD at Colorado State University. The trial plans to enroll 140 participants.

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